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TitreDateDurée
Next‑generation UTI diagnostics: delivering results in just 35 minutes07 Nov 202500:39:22

Urinary Tract infections, or UTIs, affect millions worldwide, driving sepsis, antibiotic overuse, and microbial resistance. Current diagnostics rely on either slow lab cultures or unreliable dipsticks, and often lead to delayed or unnecessary treatment. Llusern’s Lodestar DX changes that: a point-of-care test that detects 96% of key UTI pathogens in just 35 minutes, no lab required.

In this episode I’m joined by Emma Hayhurst who shares her journey into diagnostics, Llusern’s mission, and the emergence of Wales as a biotech hub with a growing life sciences sector fueling local innovation. We discuss UTI prevalence, diagnostic gaps, and how rapid, accurate testing can transform patient care and antimicrobial stewardship. 

02:14               Meet Emma Hayhurst

04:37               Introducing Llusern Scientific

07:21               Collaboration between Llusern and the academy

08:50               The life science ecosystem in Wales

12:10               Urinary tract infections (UTIs)

15:45               UTI patient demographics

16:54               Health impacts of UTIs: sepsis, antibiotic resistance, and more

19:01               Existing UTI diagnostic options and their shortcomings

24:41               Llusern’s Lodestar DX

29:03               A point-of-care test, not a lab test

31:44               Applications beyond UTIs

36:03               Looking forward at Llusern

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How AI Is revolutionizing synthetic biology and biomanufacturing31 Oct 202500:38:27

Today, I’m joined by Héctor García Martín, a Staff Scientist at Lawrence Berkeley National Laboratory. A pioneer in metabolic engineering and computational biology, Héctor has spent over a decade decoding microbial systems, everything from termite guts to genome-scale flux models, to unlock sustainable biomanufacturing.

Now, he’s leading the charge in self-driving labs: AI-powered, robotic systems that automate experiments, predict biological behavior, and accelerate the design of microbes that produce fuels, medicines, and materials.

In this episode, we’ll dive into why biology has traditionally proven so hard to engineer, how AI and robotics are changing that, and where this revolution is headed next. I hope you enjoy my discussion with Hector Garcia Martin.

01:12              Meet Hector Garcia Martin

12:47              Introduction to the Berkeley National Laboratory

14:42              Challenges in synthetic biology

17:21              How unpredictability complicates biomanufacturing

19:30              Self-driving labs at the nexus of AI, robotics, and biomanufacturing

22:23               How is AI integrated into optimize enzyme expression

28:01               Where is the market for self-driving labs?

28:47               The future of synthetic biology

32:24               The most exciting trends in AI-driven biomanufacturing

34:10               The expected impacts of self-driving labs on everyday life

35:28               Advice for aspiring scientists

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A Finnish biotech is making progress on Parkinson's disease with support from The Michael J. Fox Foundation29 Aug 202500:38:02

Parkinsons disease impacts some 10 million people worldwide and current approaches to treating the condition almost exclusively focus on addressing symptoms – there is, as of yet, no cure. One Finnish biotech, however, is not focused on alleviating symptoms but on modifying the course of the disease itself. Their hope is to be able to stop and even reverseneurodegenerative diseases like Parkinsons, and they have the backing of significant players, such as the Michael J Fox Foundation, to do just that.

This week I spoke to Antti Vuolanto, CEO of Herantis Pharma, about the work his company is doing, the science behind their approach, and the advantages and challenges of working in biotech in the Nordics.

01:10               Meet Antti Vuolanto

05:10               The biotech landscape in the Nordics

07:07               Herantis Pharma and its mission

09:38               Treating symptoms versus disease modification

13:31               Herantis in relation to other Parkinson’s disease companies

15:47               HER-096

26:24               The global burden of Parkinson’s disease and the unmet need

28:56               The role of patient and advocacy groups

30:11               The future of Parkinson’s disease treatment

31:52               How the Nordics can develop and expand their biotech sector

36:33               Stay up to date on Herantis and their work

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How quantum computing can accelerate drug discovery03 Nov 202300:28:45

On today’s podcast, Jean-Philip Piquemal, the chief scientific officer and co-founder of Qubit Pharmaceuticals, explains how the company’s Atlas platform is leading the way to more effective and safer drugs.

00:54-01:52: The history of Qubit Pharmaceuticals

01:52-04:04: What is the Atlas software?

04:04-05:18: Failing quickly is the key

05:19-06:53: What are digital twins?

06:54-09:00: Improving safety, reducing costs, and boosting drug discovery

09:00-10:44: Areas of interest

10:44-13:21: Recent successes

13:23-14:57: Preparing for future pandemics

14:58-17:03: Staying ahead of other companies

17:04-18:29: Enough diseases to go around

18:30-20:11: Upgrading Atlas software

20:13-21:59: How Qubit works with pharma companies

21:59-24:41: The Quantum for Bio program

24:42-27:58: Looking to the future, and helping patients
 

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Beyond Biotech podcast 69 – improving access to cell and gene therapy27 Oct 202300:37:06

This week, our guest on the podcast is Jason C. Foster, CEO of Ori Biotech.

Ori is a London, U.K. and New Jersey, U.S. based manufacturing technology company pioneering flexible process discovery with translation and scalable commercialization of cell and gene therapies (CGT). 

Ori has developed a proprietary, full stack manufacturing platform that closes, automates and standardizes CGT manufacturing allowing therapeutics developers to develop and bring their products to market at commercial scale. 

The promise of the Ori platform is to fully automate CGT manufacturing to increase throughput, improve quality and decrease costs by combining proprietary hardware, software, data and analytics.

Ori was founded in 2015 by Dr Farlan Veraitch from University College London.

The company also produces a monthly report on its website, which covers the latest in CGT approvals, regulations, trials and industry news.


Beyond Biotech podcast 68 – rejuvenation with stem cells20 Oct 202300:29:43

This week, our guest on the podcast is Mark Kotter, founder of newly-created company clock.bio.

clock.bio, a sister company to bit.bio, which Kotter also founded and is the CEO of, aims to extend and improve quality of life by reversing the harmful effects of time in our cells, harnessing the regenerative capabilities of human pluripotent stem cells (hiPSCs).

These hiPSCs have the ability not only to stay young but also to rejuvenate when forced to age.

Clock.bio’s approach is to harness this power of ‘resetting the clock’ in hiPSCs to identify new approaches to treating age-related diseases. It has developed an aging model that ‘force ages’ hiPSCs and triggers their self-rejuvenation mechanism. Unbiased CRISPR screens on large samples of these cells allows for the identification of gene candidates that are causally relevant for cell rejuvenation.

This enables a decoding of rejuvenation biology and corresponding IP; the resulting knowledge will be used to create novel treatment approaches.

The company’s mission is to extend health span by 20 years based on biomarkers of aging in a phase 3 trial by the end of this decade. 

Clock.bio recently published a white paper for rejuvenation therapies and a blueprint for clock.bio.


Beyond Biotech podcast 67 – natural killer cells13 Oct 202300:28:55

This week, we speak to Artiva Biotherapeutics’ CEO, Fred Aslan, M.D.

The company has demonstrated the potential for efficacy and safety with natural killer (NK) cells in two cancer clinical trials. In August, the company announced FDA clearance for an IND for lupus – marking a first for an allogeneic, off-the-shelf NK or CAR-T cell therapy in autoimmune disease.

AlloNK (also known as AB-101) is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. 

Artiva is investigating AlloNK in a phase 1/2 multicenter clinical trial to assess the safety and clinical activity of AlloNK alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva is also investigating the safety and clinical activity of AlloNK in combination with rituximab in patients with lupus nephritis. 

In addition, Artiva is collaborating with Affimed in a phase 2, open-label, multi-center, multi-cohort study, testing a combination therapy, comprised of AlloNK and the innate cell engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva selects cord blood units with the high affinity variant of the CD16 receptor and a KIR-B haplotype for enhanced product activity. 

Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors, without the need for engineering. AlloNK is being administered in the outpatient setting over multiple doses and multiple cycles.

Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has also entered into therapeutic NK cell collaborations with Merck Sharp & Dohme. 

Beyond Biotech podcast 66 – treating rare diseases with tRNA06 Oct 202300:32:08

Compared to the smallest mRNA molecule, which is 300 nucleotides long, the largest transfer RNAs (tRNA) is less than a third of the size at 76 nucleotides. 

Scientists at Alltrna are harnessing the unique biology of tRNAs to engineer a single tRNA medicine that could treat thousands of rare diseases that share the same genetic mutation. This year, Alltrna presented at ASGCT the first demonstration that an engineered, modified tRNA could recognize and correct, in vivo, a flawed mRNA instruction no matter where it occurred in the genome.

Alltrna, which was founded in 2018 by Flagship Pioneering, recently announced it had raised $109 million in a Series B financing to advance the company’s platform and first drug candidates towards the clinic for a first indication in Stop Codon Disease.  

Stop Codon Disease encompasses ​​thousands of rare and common diseases that arise from premature termination codons (PTC), also known as nonsense mutations, where the code for an amino acid has been mutated into a premature “stop” codon. This results in a truncated or shortened protein product with no or altered biological activity that causes disease. Approximately 10% of all people with a genetic disease have Stop Codon Disease, representing approximately 30 million people worldwide. Alltrna’s tRNA medicines can read these PTC mutations and deliver the desired amino acid, thereby restoring the production of the full-length protein.

The company’s platform incorporates artificial intelligence and machine learning tools to ‘learn’ the tRNA language and deliver diverse, programmable molecules with broad therapeutic potential. 

This week, our conversation is with Alltrna CEO, Michelle Werner.

To learn more about the topic, we invite you to read the following article:  Will tRNA therapy be the next big thing in genetic disease treatment?


Beyond Biotech podcast 65 – Disease X and pandemic preparedness29 Sep 202300:43:11

Disease X, a concept shrouded in mystery, represents the unknown pathogens that could unleash future epidemics or pandemics. 

In the wake of recent global health crises, our understanding of the profound impact of those pandemics has deepened. 

On this week’s podcast, we have a conversation with Hamilton Bennett, who led Moderna’s mRNA-1273 COVID-19 vaccine development program team to the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. 

Bennett is Moderna’s senior director of vaccine access and partnerships, and has unparalleled insights into the world of infectious diseases. 

In this in-depth discussion, Bennett talks about the origins of Disease X, the role of mRNA technology in tackling pandemics, and the importance of preparedness.

Disease X was intended to be a placeholder name; it was adopted by the World Health Organization (WHO) in February 2018 on their shortlist of blueprint priority diseases to represent a hypothetical, unknown pathogen that could cause a future epidemic.

Beyond Biotech podcast 64 – Precision immuno-oncology therapies22 Sep 202300:38:31

Despite the huge commercial success of PD-1 inhibitors and widespread use of checkpoint inhibitors such as anti-PD-1 or anti-CTLA4, 70 to 80% of patients still experience limited or no response to existing therapies.  

In response to this critical challenge, Portage Biotech is on a mission to expand the number of patients who derive long-term benefits from immunotherapies.  

Portage Biotech is advancing a portfolio of novel precision immuno-oncology therapies, including invariant natural killer T-cell (iNKT) engagers, designed to correct the tumor microenvironment and enable the body to recognize and attack tumors, and next-generation adenosine inhibitors for a variety of cancers, with better potency, selectivity and durability. 

Heading this pioneering endeavor is Dr. Ian Walters, Portage's CEO, who brings decades of experience in the immuno-oncology space. With a unique background as a physician with a business degree, Dr. Walters has been deeply involved in academia and large pharmaceutical companies. He played a pivotal role in the development of some of the first checkpoint inhibitors and has supported the approval of five oncology drugs.  

In this conversation, Walters tells Labiotech about Portage's unique approach to targeting known checkpoint resistant pathways and the company's strategy to revolutionize immunotherapy research and drug development.


Beyond Biotech podcast 63 – Tackling cancer with STRIs15 Sep 202300:33:32

This week’s podcast is sponsored by Vetter.

On this week’s episode, we have a conversation with Steve Worland, CEO of eFFECTOR Therapeutics.

eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs (selective translation regulation inhibitors). 

eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes. 

The company’s product candidates are designed to act on a single protein that drives the expression of a network of functionally related proteins, including oncoproteins and immunosuppressive proteins in T cells, that together control tumor growth, survival and immune evasion. 

The lead product candidate, tomivosertib, is an MNK inhibitor currently being evaluated in KICKSTART, a randomized, double-blind, placebo-controlled phase 2b trial of tomivosertib in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC). 

Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in phase 2a expansion cohorts in certain biomarker-positive solid tumors, including ER+ breast cancer and KRAS-mutant NSCLC. 

eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E.


Beyond Biotech podcast 62 – cytokine-based drugs08 Sep 202300:33:42

As September 8 is Stand Up To Cancer Day, one area of promising research lies in cytokine-based drugs, which have the potential to activate T cells against tumors. Historically, toxicity from systemic cytokine treatment has remained a challenge, prompting several companies to explore ways to “engineer” drugs with modified cytokine molecules like interleukin 2 (IL-2) for targeted and safer delivery.  

Cue Biopharma is a standout in this field, harnessing nature’s ‘cues’ to selectively activate the immune system against cancer. Their approach overcomes IL-2’s narrow therapeutic window by directing IL-2 delivery specifically to cancer cells, targeting only disease-specific T cells.  

Cue Biopharma is a Boston, U.S., based clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT (Selective Targeting and Alteration of T cells) and biologics are designed to harness the body’s intrinsic immune system as T cell engagers without the need for ex vivo manipulation or broad systemic immune modulation.

Anish Suri, Cue’s chief scientific officer, spoke with us about Cue Biopharma’s platform and its approach in the evolution of immunotherapies. 


Beyond Biotech podcast 61 - Blood Cancer Awareness Month01 Sep 202300:24:44

On this week’s podcast, to recognize Blood Cancer Awareness Month, we have a conversation with Affimed's CMO, Andreas Harstrick, to talk about blood cancers, and what Affimed is doing to tackle blood cancers.

One of the main challenges in treating blood cancers is the limited options for therapeutic intervention. Treatment relies primarily on chemotherapy, which is often associated with high toxicity and limited duration of response. Most other approaches to treating hematologic tumors target the adaptive immune system, neglecting the importance of innate immunity. However, harnessing the body’s first line of response could be an important gateway to treating these cancers, which could drastically lower side effects and overcome immune evasion by cancers, especially in refractory or relapsed patients. 

Approaches based on the innate immune system mainly utilize NK (natural killer) cells. Innate Pharma, Dragonfly Therapeutics, and Affimed are among the biotech companies directing NK cells to tumors with the help of bi- or multi-specific antibodies. 

Affimed has completed a phase 2 trial with its innate cell engager (ICE), AFM13. To address the fact that cancer patients often lack a functional immune system, Affimed has combined its ICE approach with PD-1 inhibitors or allogeneic cord blood-derived NK cells to further increase the potential success of its treatments. 

Initial results from an exploratory study together with MD Anderson have already provided encouraging data with relapsed or refractory patients that previously exhausted all treatment options showing a complete response rate of 71% when treated with AFM13 precomplexed with cord blood-derived NK cells.


How RNAi is expanding from a therapy of choice for rare disease into treating common conditions22 Aug 202500:48:01

RNAi has changed the way that rare diseases are treated - is it about to do the same for more common conditions?

Alnylam was the very first company to translate RNAi from Nobel Prize winning science into a commercially scalable platform. Founded in 2002, the company today has five different RNAi therapies on the market and a pipeline that continues to expand. While their early focus was on rare disease, today they are expanding into more common conditions, partnering with top pharma companies to bring next-generation therapies to market.

This week I sat down with Paul Nioi, Senior Vice President of Research at Alnylam. Paul has more than 20 year’s experience in biotech and biopharma, and he walked me through Alnylam’s mission and place in the biotech ecosystem, the science of RNAi, the early success treating metabolic disease, and exactly where their platform is expanding into now and in the near future. Paul explains the capacity of RNAi to address neurological and infectious disease, the value of large-scale genomic initiatives, and how he sees drug discovery evolving in the years ahead.

01:29               Meet Paul Nioi

08:56               Alnylam, its mission, and its science

14:35               Two types of partnerships: top pharma, and genomic initiatives

22:34               RNAi therapies on the market for rare disease

27:29               Expanding into more common conditions

32:17               INHBE mutations and cardiometabolic disease

35:01               Working with Roche to target hypertension

38:58               Looking forward: Alnylam’s platform in the near future

41:49               What role for national genomic initiatives?

45:16               RNAi’s place in a future of precision medicine

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Beyond Biotech podcast 60 – The cost of research25 Aug 202300:33:45

On this week’s podcast, we have a conversation with Dr Jack Scannell, CEO of Etheros Pharmaceuticals Corp. Scannell recently co-authored a paper on the expenses related to clinical research and the factors that underly the translational failure of inhibitors of the insulin-like growth factor-1 receptor (IGF-1R) in oncology.

Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors, published in Jama Network Open, looked at 16 inhibitors of IGF-1R, in 183 clinical trials involving more than 12,000 patients. None of the agents received approval for clinical use in oncology practice and the trials were estimated to have had expenses of greater than $1.6 billion. Half of the published in vivo preclinical data analyzed showed less than a 50% inhibition of tumor growth by IGF-1R inhibitors.

The authors stated that failed drug development in oncology incurs substantial expense. At an industry level, an estimated $50 billion to $60 billion is spent annually on failed oncology trials. 

Improved target validation and more appropriate preclinical models are required to reduce attrition, with more attention paid to decision-making before launching clinical trials. A more appropriate use of resources may better reduce cancer mortality, the authors argued.


Beyond Biotech podcast 59 – World Lung Cancer Day18 Aug 202300:19:11

Since its inception in 2012, World Lung Cancer Day has been observed every year on August 1 in order to raise awareness of lung cancer issues and magnify the need for more lung cancer research funding.

Around a quarter of a million people in the US alone will be diagnosed with some form of lung cancer in 2023. And more than 125,000 people in the US will die from the disease. And another pretty awful stat is that one in 16 men and one in 17 women will be diagnosed with lung cancer, which kills three times as many people as breast cancer or prostate cancer. However, there are some positive trends. 

The number of new lung cancer diagnoses is declining steadily. Since 2006, the incidence rate decreased by 2.6% per year in men and 1.1% per year in women. Mortality rates are declining even faster, because of advances in treatment and early detection.

This week’s guest is Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center, to talk about a new diagnostic tool for lung cancer.

Sheba Medical Center’s new AI cancer diagnostics platform reduces diagnosis time

Sheba Medical Center, Israel’s largest medical center, has announced the deployment of a new accelerated, AI-powered cancer diagnostics research platform to improve patient diagnosis,  treatment and outcomes. The platform enables the integration of AI technology developed by Sheba in addition to solutions created by innovative digital health startups.

One of the first AI solutions to be deployed was developed by Imagene, an emerging leader in AI-based precision oncology, incorporating an algorithm to identify actionable biomarkers of non-small cell lung cancer. The algorithm is directly applied to a digitized image of a conventionally stained pathology slide and can then, within minutes, identify the presence of actionable biomarkers in the tumor, thus providing crucial information for diagnostic and therapeutic decisions. The solution essentially shortens diagnostic time from three weeks to minutes, enabling patients to begin treatment earlier. 

“We have reached another significant milestone in digital pathology with this ability to detect biomarkers by AI. The use of deep learning algorithms is changing the world of diagnosis, and in certain cases can drastically shorten the cost and time to treatment. I am excited to hear about the growing number of patients who were able to receive rapid diagnoses and treatment using our new service,” said Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center.

This latest advancement in cancer diagnostics builds on the progress Sheba’s Pathology Institute has made in recent years. In 2019, the pathology lab at the hospital went fully digital, using computer screens for diagnosis instead of microscopes. Once the lab turned fully digital, the team worked with Imagene who developed a rapid AI-based molecular profiling algorithm to identify actionable biomarkers from the digital biopsy image alone.        

“We are very proud to be part of this incredibly important initiative by Prof. Barshack to facilitate an accelerated program for rapid diagnosis of cancer patients,” said Dean Bitan, co-founder and CEO of Imagene. 

“It takes an innovative approach and openness to new and advanced technologies to drive cancer research and advanced cancer care. We believe this program will showcase the importance of rapid molecular profiling within the clinical workflow.” 

To dive deeper into the topic: 

Beyond Biotech podcast 58: Pepteins11 Aug 202300:19:56

To learn about pepteins, we had a conversation with Christian Schwarz, CEO and co-founder of Numaferm.  

Numaferm is a German biotech company, specializing in the production of pepteins, which are an underdeveloped class of molecules located between peptides and proteins (with a length of 30-300 amino acids). Pepteins are non-structured and complex posing a challenge for manufacturing, yet exert a high biological activity, wherefore they play an increasing role as innovative molecules in a range of industries, including animal and human health.  

To date, peptein production via chemical synthesis or recombinant approaches is cumbersome, leading to time and resource-intensive development programs. This, in combination with high production costs, limits promising peptein applications. 

The proprietary high-titer expression platform Numaswitch changes this situation and enables the access to pepteins within weeks. 

The company and Zoetis, an animal health company, recently signed a licensing agreement for the development and production of defined veterinary therapeutics.  

Beyond Biotech 57: Group B Strep04 Aug 202300:30:51

2:02 Labiotech.eu news
2:51 MinervaX 

To recognize International Group B Strep Awareness Month in July, we had a conversation with MinervaX CEO, Per Fischer. 

MinervaX is a privately-held Danish biotechnology company developing a novel prophylactic vaccine against Group B streptococcus (GBS), with two phase II clinical trials ongoing in pregnant women and a phase I clinical trial ongoing in older adults. 

Due to the global burden and no current mechanism for preventing this invasive GBS disease available. There is an urgent need for a vaccine to prevent GBS which has a well-recognized morbidity and mortality rate. 

MinervaX’s GBS vaccine has been granted Fast Track regulatory status by the US Food and Drug Administration. The process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.  

This follows the European Medicines Agency’s decision to award Priority Medicine (PRIME) status to the vaccine.

Beyond Biotech podcast 56: BaseLaunch28 Jul 202300:35:31

2;00  Labiotech news
3:36  BaseLaunch

In today's episode, we have a conversation with Stephan Emmerth, director business development and operations at biotech startup incubator BaseLaunch, and Sai Reddy, an entrepreneur well versed in the highs and lows of the biotech startup journey. 

The discussion includes BaseLaunch’s approach to empowering early-stage biotech entrepreneurs with not just financing, but also the necessary tools for success, from team-building to IP licensing.

 Emmerth and Reddy offer their perspectives on the realities of building a biotech startup, the perfect time to transition from a lab to a new venture uncover the significance of choosing the right team making this episode a must-listen for anyone looking to navigate the biotech landscape successfully. 









Beyond Biotech podcast 55: Inflammasomes20 Jul 202300:33:10

1:54  Labiotech news
3:48  NodThera

This week, we’re talking about inflammasome inhibitors with Alan Watt, CEO of NodThera.

The company recently announced it is the first to show a reduction in neuroinflammation with an inflammasome inhibitor.

​​NodThera announced positive initial data from four subjects in the elderly volunteer stage of its phase Ib/IIa study evaluating the effects of its lead candidate NT-0796 on inflammatory and disease-specific biomarkers in the blood and cerebrospinal fluid (CSF).

NodThera is a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases.

Initial data from the ongoing study confirm earlier findings from the completed first-in-human and preclinical studies with NT-0796 showing excellent pharmacokinetics with a novel capsule formulation.

Subjects in the study were cannulated and CSF-sampled on day one (pre-dose) and day seven following daily NT-0796 dosing. CSF drug levels were confirmed as consistent with previous observations and a range of inflammatory CSF biomarkers demonstrated meaningful reductions.

Neurofilament light chain (NfL), exclusively synthesized in the central nervous system (CNS), decreased by approximately 25% over seven days in the most inflamed subject and by 13% on average. NfL is now recognised by the U.S. Food and Drug Administration (FDA) as a key biomarker of neuroaxonal damage and neurodegeneration.

Beyond Biotech 5414 Jul 202300:27:48

1:24  Labiotech news
3:45  TolerogenixX

TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, has announced that its phase IIb study in renal transplant patients has received the green light to initiate the B arm of the study

MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis. 

TolerogenixX has already reported positive results from the one- and three-year follow-up of 10 transplant recipients of its TOL-1 phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course three years after surgery. 

Beyond Biotech podcast 53: Antibody-drug conjugates07 Jul 202300:26:35

2:55  Labiotech news
4:27  Mablink Bioscience

On the podcast this week, we have a conversation about antibody-drug conjugates with Pejvack Motlagh, who was recently announced as the chief medical officer at Mablink Bioscience. 

Mablink Bioscience 

Mablink Bioscience is a biotechnology company developing the next generation of an emerging class of cancer drugs, antibody-drug conjugates (ADCs). 

Mablink’s patented hydrophilic drug-linker technology, PSARLink, enables the design of homogeneous, plasma-stable, next generation ADCs with high DAR (drug-to-antibody ratio) while maintaining pharmacological properties and tolerability.

The company recently announced the appointment of Dr. Pejvack Motlagh as chief medical officer. 

“We are very pleased to welcome Dr. Pejvack Motlagh as our chief medical officer. His experience in managing oncology portfolios, especially in the immuno-oncology and large molecules’ space, will be a great asset to take Mablink’s pipeline of innovative therapies to the next level,” said Jean-Guillaume Lafay, CEO of Mablink. 

“As MBK-103 enters the last preclinical phases, Pejvack’s appointment is a very important step in making Mablink’s clinical ambitions a reality.”

We spoke with Motlagh about his work, Mablink, and antibody-drug conjugates.



Beyond Biotech podcast 52: Antiphospholipid syndrome30 Jun 202300:43:46

2:38  Labiotech news
4:23  APSFA
20:59 University of Michigan

June is Antiphospholipid Syndrome (APS) Awareness Month. 

APS is a rare autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. There are two known forms. APS may occur in people with systemic lupus erythematosus, other autoimmune disease, or in otherwise healthy individuals.

APS is also referred to as APLS or APLA in the U.S., and formerly Hughes Syndrome or Sticky Blood in the U.K.

On the podcast this week, we spoke with Tina Pohlman, who suffers from APS, and who is president of the APSFA, about the disease and the organization.

The APS Foundation of America, Inc. (APSFA) was founded in 2005, and is the only U.S. nonprofit health agency dedicated to bringing national awareness to APS, a major cause of multiple miscarriages, thrombosis, young strokes and heart attacks. 

The APSFA’s Medical Advisory Team includes nationally & internationally recognized experts on Antiphospholipid Syndrome.

We also had a conversation with APS researcher Dr Jason Knight, Marvin and Betty Danto Research Professor of Connective Tissue Research and Associate Professor, Division of Rheumatology at the University of Michigan.

Current APS trials


There are currently several clinical trials being undertaken with respect to APS. University Hospital, Clermont-Ferrand, France, is looking to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, and argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.

David Ware Branch, from the University of Utah, is also undertaking a trial with results expected in 2024. The treatment trial is evaluating the addition of an anti-tumor necrosis factor-alpha drug,certolizumab, compared to the usual treatment (a heparin agent and low-dose aspirin) in pregnant women with APS and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.

Another study, in China, also with results anticipated in 2024, is being run by Zhang Lei. The study aims to evaluate the safety and efficacy of zanubrutinib in the treatment of APS with secondary thrombocytopenia in 10 patients.

The University of Turin in Italy is sponsoring BLAST (belimumab antiphospholipid syndrome trial), which is expecting to see results in 2025. BLAST aims to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin.





Beyond Biotech podcast 5123 Jun 202300:54:38

1:13  Labiotech news
3:09  Lund Spring Symposium
27:36 Sapient

Sapient

Sapient is an end-to-end biomarker discovery organization dedicated to accelerating the mapping of circulating chemistries in humans through rapid, large-scale small molecule biomarker profiling. 

Its platform combines next-generation mass spectrometry technologies capable of assaying tens of thousands of small molecule biomarkers in human biosamples, advanced biocomputational learning, and a proprietary Human Biology Database with extensive data from several hundred thousand biosamples. 

Together these approaches enable rapid discovery and validation of circulating biomarkers of health, disease, and drug responsiveness at unprecedented speed and scale.

We spoke with founder and CEO of Sapient, Mo Jain. 

Lund Spring Symposium

The inaugural Lund Spring Symposium held in Lund, Sweden from May 24 to 26. It was an impressive forum where an exceptional set of international and national top researchers, entrepreneurs, and business leaders gathered around the subject of ‘Enabling Novel Therapeutic Principles,’ with examples of actual treatment breakthroughs, as well as novel modalities across therapeutic areas ranging from cancer, COVID-19 to neuroscience.

Six researchers were awarded for their groundbreaking discoveries and outstanding achievements: Craig Crews Yale University; Brian Kobilka, Stanford University; Robert Langer, MIT; Jude Samulski, University of North Carolina; Sarah Tabrizi, University College London; and Drew Weissman, University of Pennsylvania.

The symposium also featured two other Nobel Prize laureates, David Julius, from the University of California San Francisco, who gave a presentation, and Bengt Samuelsson, after whom one of the awards was named.

The organizer, Lars Grundemar, Lund University and AGB Pharma, decided together with Mikael Dolsten, Lund University, and chief scientific officer, president R&D, Pfizer, and Claes Wahlestedt, Lund University and University of Miami Miller School of Medicine, to create the event featuring high-profile international and local researchers at a symposium in Lund to raise the profile of pharmacology as a cross-functional discipline in the 21st century, and to provide a forum to facilitate collaborations across academia and industry.

“This event was designed to reflect the importance of combining basic research with clinical applications and entrepreneurship in successful development of novel therapeutic principles,” Grundemar said. 

The symposium was intended for scientists and entrepreneurs to be an engaging and interactive forum to broaden the participants’ horizons of cutting-edge science.

The Lund Spring Symposium will be held biannually, with the next event taking place in 2025.

Are next-generation psychedelics the way forward for addressing treatment resistant depression?15 Aug 202500:49:07

Nearly 1 billion people around the world suffer from mental health disorders, with the global economic cost of those disorders expected to reach $6 trillion by 2030. 

One of the most common of those mental health disorders is depressive disorder, commonly called depression, with some 280 million people suffering from either mild, moderate or severe depression.

Conventional treatments for depression such as selective serotonin reuptake inhibitors, or SSRIs, can work for many people but for some suffering from treatment resistant depression, options can be limited, but some new therapies are in the clinic and might offer some hope. 

Beckley PsyTech is a UK biotech that is working with next-generation psychedelic-based compounds administered in a short clinic visit once every two months. With positive results from their recent Phase 2B study and a partnership with atai Life Sciences, Beckley believes they are on their way to redefining how depression is treated.

01:38               Meet Cosmo Feilding

03:04               Beckley PsyTech, its mission and its focus

08:36               BPL-003 and next generation psychedelics

11:16               Intranasal delivery and its advantages

14:26               Psychedelics in the clinic and Phase IIb trial results

18:32               Safety: suicide signals and adverse events

21:02               Applications for psychedelics outside of depression

24:11               The global economic costs of mental health disorders

27:40               Comparing Beckley PsyTech to Compass Pathways and GH Research

35:26               Regulatory hurdles and the stigma around psychedelics

38:14               Partnering with atai Life Sciences and the future of Beckley PsyTech

43:16               Milestones ahead for Beckley PsyTech

45:44               A future vision for patients suffering from depression

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Beyond Biotech podcast 50: cell and gene therapy16 Jun 202301:09:01

2:45  Labiotech news
4:58  Orgenesis
22:35 CellProthera
38:22 Terumo Blood and Cell Technologies
52:02 BioSenic

The International Society for Cell & Gene Therapy (ISCT), the global society of more than 3,000 members dedicated to the translation of cell and gene therapies (CGT) into safe and effective treatments to improve patient lives, recently hosted the largest translation-focused event connecting academic, regulatory and industry experts from around the world to collaborate and find tangible solutions to the most critical issues affecting the development of advanced therapies.

The event took place in Paris, France.

The ISCT 2023 Translational Pathway Program featured plenary and concurrent sessions designed to address and overcome barriers at each stage of development across a full range of modalities such as CAR T, iPSC, and a dedicated half-day program on unlocking the potential of exosomes (EVs). 

In this week’s podcast, we look into two of the sessions: ‘Will allogeneic cell therapy replace autologous when it comes down to patient access?’ and ‘Have exosomes replaced MSCs?’ 

Our guests to talk about these subjects are Carole Nicco, CSO at BioSenic; Dalip Sethi, director of scientific affairs, Terumo Blood and Cell Technologies; Matthieu de Kalbermatten, CEO of CellProthera; and Vered Caplan, CEO of Orgenesis. 



Beyond Biotech podcast 4909 Jun 202300:25:17

1:24  Labiotech news
3:40  BC Platforms

A conversation about precision medicine with Tero Silvola, CEO at BC Platforms. We also discuss the acquisition of 4Pharma.

The acquisition expands BCP’s global service offering for accelerating the translation of innovations into clinical practice. In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.

4Pharma (HQ Turku, Finland and Lund, Sweden) was founded more than 20 years ago, and has collaborations with around 70 clients in the Nordics, Central Europe, and the U.S. The company has developed expertise in a range of therapeutic areas including oncology, neurology, ophthalmology, musculoskeletal, respiratory diseases, infectious diseases, and gynecology. 

The company provides medical research services in several areas: high-quality and cost-effective solutions for the management and delivery of clinical trial data, including real world data; medical writing; patient safety data collection, analysis, and reporting including data visualization; trial design & interpretation; health technology assessment; global regulatory submissions to the FDA (U.S.), EMA (Europe) and PMDA (Japan); and risk-based patient monitoring. With this acquisition BCP bolsters its capabilities in these areas for drug development and clinical research, which further diversifies its service portfolio for pharma and biotech clients.

Tero Silvola, CEO at BC Platforms, said: “This exciting acquisition of the excellent 4Pharma brings impressive healthcare data intelligence expertise. It aligns with our vision to build a world leading analytics platform to enable the pharmaceutical industry’s advancement of precision medicine, improving the efficiency of drug development and patient outcomes. This expands our service offering to healthcare and lifesciences customers, as well as connecting data partners in a global, interoperable federated network. We combine omics and clinical data assets around the world, without compromising data privacy and security. This enables our customers to conduct novel research and discover fascinating new insights to advance healthcare which are fundamental to helping patients receive better treatments and care.”

Beyond Biotech podcast 4802 Jun 202300:26:04

1:18  Labiotech news
3:37  BioInvent

BioInvent International AB, a Swedish biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, recently announced positive phase 1a data on the oncolytic virus BT-001 for the treatment of solid tumors.

BioInvent currently has four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The company's validated, proprietary F.I.R.S.T technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company's own clinical development pipeline and providing licensing and partnering opportunities.

BioInvent generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the company's fully integrated manufacturing unit.

We spoke with CEO Martin Welschof and Cecilia Hofvander, senior director investor relations.

Beyond Biotech podcast 4726 May 202300:25:42

1:33  Labiotech news
3:31  Daiichi Sankyo/AstraZeneca

The companies Daiichi Sankyo and AstraZeneca have worked together for several years.

This week’s podcast is sponsored by Daiichi Sankyo and AstraZeneca.

On this week’s podcast, we have a conversation with Markus Kosch, the head of Oncology Europe and Canada for Daiichi Sankyo, and Greg Rossi, Senior Vice President, Oncology, Europe and Canada, from AstraZeneca, who are joining forces to bring new oncology medicines into clinical practice. 

In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize health technologies worldwide. Their collaboration is designed to leverage strengths and combine efforts to improve patient care.

Beyond Biotech podcast 46: International Clinical Trials Day19 May 202300:46:42

4:26  Labiotech news
6:36  Medidata
21:43 Bill & Melinda Gates Research Institute

This week’s podcast is sponsored by Jubilant Biosys.

May 20 is International Clinical Trials Day.

ECRIN,  the European Clinical Research Infrastructure Network, is a not-for-profit organization that supports the conduct of multinational clinical trials in Europe. Based in Paris, France, the organization launched International Clinical Trials Day (ICTD) in 2005 to commemorate the day when James Lind started his clinical trial on scurvy in 1747, on May 20.

ECRIN is hosting an event, both in-person and online, on Monday, May 23, called Decentralised Clinical Trials: challenges and opportunities. While the physical event in Warsaw, Poland, is full, online registration can be found here.

International Clinical Trials Day is also supported and promoted by a range of charities, companies and organizations, such as the 13,000-member Association of Clinical Research Professionals (ACRP), which is the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals.

To celebrate the day, we have two interviews about the importance of the event and clinical trials in general. We have conversations with Dr. Michael Dunne, head of development and chief medical officer of the Bill & Melinda Gates Medical Research Institute, and Kelly McKee, vice president, decentralized clinical trials (DCT) and patient registries at Medidata.

Beyond Biotech podcast 45: International MPS Awareness Day12 May 202300:26:33

This week’s podcast is sponsored by Quantoom.

International MPS Awareness Day

May is the big month when it comes to awareness - there are almost 100 awareness months, weeks, and days being marked.

Some of these are well known conditions. Others, however, are less prominent.

International MPS (mucopolysaccharidosis) Awareness Day takes place on May 15.

According to the National MPS Society in the U.S., mucopolysaccharidosis (MPS) and mucolipidosis (ML) are genetic lysosomal storage diseases (LSD) caused by the body’s inability to produce specific enzymes. 

The missing or insufficient enzyme prevents cells from recycling waste, resulting in the storage of materials in cells throughout the body. As the disease progresses, there is widespread damage throughout the body, including the heart, bones, joints, respiratory system and central nervous system, leading to a shortened lifespan.

There are 12 different forms of MPS.

For example, MPS I includes Hurler Syndrome, Scheie Syndrome and Hurler-Scheie Syndrome, while MPS II covers Hunter Syndrome.

Hurler Syndrome takes its name from Gertrude Hurler, the doctor who described a boy and girl with the condition in 1919. In 1962, Dr. Scheie, a consultant ophthalmologist, wrote about patients who were more mildly affected. Individuals who do not fit the severe or mild ends of the disease were said to have Hurler/Scheie. The specific disease names have been replaced with the designations attenuated (diminished severity) and severe MPS I. MPS I has a wide range of symptoms that vary in severity and can be managed and treated with enzyme replacement therapies. There is no cure for MPS I. 

Mucopolysaccharides are chains of sugar molecules used to build connective tissues in the body. MPS I patients are missing the enzyme alpha-L-iduronidase, which is essential in breaking down the mucopolysaccharides dermatan sulfate and heparan sulfate. These materials remain stored in the body’s cells, causing progressive damage. Babies may show little sign of the disease, but as cells sustain damage, symptoms start to appear.

To talk about the disease, treatments, research, and the future prognosis for those with MPS, is Dr Matthew Ellinwood, chief scientific officer at the National MPS Society.

Beyond Biotech podcast 4405 May 202300:35:22

3:32  Labiotech news
5:33  Lupus interview

This week’s podcast is sponsored by Lonza.

May is Lupus Awareness Month, and to talk about lupus with us this week on the podcast are Katherine Tran, senior global market development & marketing manager of the proteomics division at SCIEX, and Allan Stensballe, associate professor, Department of Health Science and Technology and associate professor, The Faculty of Medicine, at Aalborg Universitet in Denmark.

Each May, The Lupus Foundation of America gathers the lupus community to make lupus visible.

Lupus is a chronic autoimmune disease where the immune system can’t tell the difference between healthy tissues and foreign invaders. This can result in inflammation, pain, and damage to any organ system in the body. Common symptoms include extreme fatigue, debilitating joint pain, skin rashes, and swelling. While lupus can affect anyone, people with lupus overwhelmingly consist of women and disproportionately impacts certain racial and ethnic backgrounds, including Black/African-American, Hispanic/Latino, Asian-American and Pacific Islander.

Due to the mysterious and elusive nature of this disease, many of the symptoms of lupus aren’t always visible, and can often result in years of misdiagnosis and inadequate treatment. And, because many of its symptoms and impact aren’t always seen, it can lead to those living with lupus to feel misunderstood and isolated.



Beyond Biotech podcast 4328 Apr 202300:31:46

2:13  Labiotech news
5:17  bit.bio

This week’s podcast is sponsored by Scientist.com.

The mainstream news in the past couple of months has picked up on artificial intelligence (AI). Not so much its uses, more the potential for conflict and fears over AI developing too quickly, or ‘taking over humanity.’

Debates have sprung up around deepfakes, ChatGPT, and other AI technologies, and there are concerns over how new technology will impact our everyday lives. The debate covers ethics, regulations, law, education; in fact AI and the future seem intertwined. 

AI has been around for some time, it’s just increased sophistication has brought it more into the spotlight. There are many positives to AI, not least in the life sciences. We now have the potential to analyze far more data, and there is real potential for identification of new drugs and drug targets being found through new technology. Of course, AI has other applications in science, such as climate change and sustainability, and in food technology.  

AI and machine learning were just some of the topics Labiotech discussed with Mark Kotter, CEO of U.K. biotech bit.bio.

bit.bio is a synthetic biology company providing human cells for research, drug discovery and cell therapy. The company applies a patented safe harbor gene-targeting approach to inducibly express transcription factor combinations that reprogram human induced pluripotent stem cells (iPSCs) into highly defined and mature human cell types. 

The company is currently building a clinical pipeline and marketing a range of cells and disease models for research and drug discovery under its ioCells brand. This includes nerve cells, immune cells and muscle cells. 

The company was spun out of the University of Cambridge in 2016, and has since raised $150 million capital from Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, and Puhua Capital among others.

Beyond Biotech podcast 4221 Apr 202300:32:35

2:05  Labiotech news
3:32  MEET2WIN
9:38 Lund Spring Symposium
19:31 Merck

This week, we’re talking about the upcoming Lund Spring Symposium with Claes Wahlestedt, Leonard M. Miller professor and director of the Center for Therapeutic Innovation (CTI) and associate dean for therapeutic innovation at the University of Miami Miller School of Medicine;  about Meet2Win with Lucia Robert, CEO of MATWIN which stages the event; and then an interview with two people, Andrew Clutterbuck, associate director MSAT EMEA and Mark Peacock,  director, technical applications, from Merck.

This week’s podcast is sponsored by Merck.

Merck is a science and technology company, operates across life science, healthcare and electronics. The company provides products and services that accelerate drug development and manufacturing as well as discovering ways to treat the most challenging diseases to enable the intelligence of devices. 

Merck holds the global rights to the Merck name and brand. The only exceptions are the U.S. and Canada, where the business sectors of Merck operate as MilliporeSigma in life science.

Lund Spring Symposium

A new event, which will include presentations by Nobel laureates, is set to showcase the best of pharmacology.

The Lund Spring Symposium, which takes place from May 24 to 26 at the Palaestra et Odeum in Lund, Sweden, aims to raise the profile of pharmacology as a cross-functional discipline in the 21st Century and to provide a forum to facilitate collaborations across academia and industry.

MEET2WIN

The 8th annual MEET2WIN event takes place in Bordeaux, France, from May 11 to 12. 

The MEET2WIN convention, staged by MATWIN (Maturation & Accelerating Translation With Industry) brings together nearly 300 European players specifically involved in translational research and innovation in oncology (researchers, clinicians, entrepreneurs, biotechs, pharmaceutical groups, investors, support structures, etc.) looking to expand their network of contacts and optimize their collaboration around the fight against cancer.

More than 1,000 companies and organizations attend the event, with more than 5,000 meetings scheduled. 

Beyond Biotech podcast 41: Sarcoidosis14 Apr 202300:25:35

1:44  Labiotech news
3:27  Molecure

This week, to coincide with World Sarcoidosis Day, April 13, we talk about sarcoidosis with Marcin Szumowski, CEO and president of the management board of Molecure. 

World Sarcoidosis Day

As part of Sarcoidosis Month, which is marked each April, World Sarcoidosis Day is on April 13. But what is sarcoidosis?

The Foundation for Sarcoidosis Research explains that it is an inflammatory disease characterized by the formation of granulomas—or small clumps of inflammatory cells—in one or more organs of the body. 

When the immune system goes into overdrive and too many of these clumps form, they can interfere with an organ’s structure and function. When left unchecked, chronic inflammation can lead to fibrosis, or permanent scarring of organ tissue. 

Sarcoidosis affects the lungs in around 90% of cases, but it can affect almost any organ in the body. Despite advances in research, sarcoidosis is difficult to diagnose, and has limited treatment options. There is no known cure.

In the U.S. alone, there are between 150,000 and 200,000 people with the condition, with around 1.2 million individuals with sarcoidosis worldwide.

Molecure

Molecure is a clinical stage biotechnology company that uses its medicinal chemistry and biology capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate the function of underexplored protein and RNA targets to treat multiple incurable diseases.

Molecure has generated a diverse pipeline of seven programs with the support of academic life science institutions globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).

Molecure’s most advanced in-house drug candidate is OATD-01, a first-in-class inhibitor of CHIT1 for the treatment of interstitial lung diseases, such as sarcoidosis and idiopathic pulmonary fibrosis, which is phase II ready. A phase II trial in patients with sarcoidosis is expected to start in the second half of 2023.

Its second proprietary candidate is OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, which advanced to phase I clinical development in March 2023.

Molecure’s headquarters and laboratories are located in Warsaw, Poland, with an additional laboratory facility in Łódź.

Day One DNA: How and why the UK is betting on whole genome sequencing for every newborn 08 Aug 202500:49:57

The UK is preparing to change the game for healthcare - but why, how, and what will it cost?

Recently the UK government announced plans to sequence the DNA of every baby born in that country. A part of the country’s 10 Year Health Plan, the program aims to identify rare genetic diseases early, prevent harms from delayed treatment and reduce future healthcare costs for the NHS. Yet along with those potential upsides come a range of ethical and practical questions, too: who guards the sequenced data, who can access it, how can consent be informed, managed and withdrawn years later, and what is the best way to gather the genetic material required to fully sequence the DNA of 700,000 infants each year?

This week, I spoke to Neil Ward of PacBio to understand more about this program, compare it to other national genome sequencing programs in Europe and Asia, and discuss the promise of unlocking the ‘language of life’.

02:02               Meet Neil Ward

09:10               PacBio, its mission, and its current focus

17:13               The UK national newborn gene sequencing effort

21:20               Ethical and practical challenges for national newborn sequencing

24:34               Short-read versus long-read sequencing

30:48               Dried blood spots versus cord blood

35:57               Lessons for the UK from Thailand

38:58               Trends in national newborn screening programs worldwide

41:46               What parents and policymakers must know

45:20               Exciting things in the genomics space on the horizon

This episode is brought to you by MedChemExpress.

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Beyond Biotech podcast 40: Antibody drug conjugates31 Mar 202300:43:09

3:13  Nectin Therapeutics
26:47 Immunome

This episode of the podcast is an in-depth look at antibody drug conjugates (ADCs). Our guests are Dr Pini Tsukerman, chief scientific officer of Nectin Therapeutics, and Matthew Robinson, chief technology officer of Immunome.

This episode of the podcast is sponsored by PHTA.

Immunome

Immunome’s Discovery Engine leverages the information stored in memory B cells to guide the discovery of first-in-class antibody therapeutics directed at potentially novel targets in oncology and other areas. 

Immunome’s research has revealed - and continues to unveil - novel target classes, such as proteins ectopically expressed on the surface of cancer cells, which are uniquely tumor selective and potentially suitable for development as ADCs. 

The company talked about those applications recently at World ADC London and has also established an ADC and T Cell Redirection Advisory Board to prioritize selection of novel targets for ADC and TCR modalities. Immunome’s focus is on discovering and developing therapeutics in oncology internally and in collaboration with partners, including through a recently established strategic collaboration with AbbVie. 

Nectin Therapeutics

Nectin Therapeutics is a clinical-trial biotechnology company developing new immuno-oncology therapies to address resistance towards existing cancer treatments. 

In addition to its collaboration with Merck (MSD) to trial KEYTRUDA (pembrolizumab) with Nectin’s novel anti-PVR antibody, NTX1088, Nectin is also working on developing three ADCs in its drug discovery pipeline. 

Beyond Biotech podcast 39: World Tuberculosis Day24 Mar 202300:54:35

2:57 Labiotech.eu news
4:17 PBD Biotech
14:52 AAHI
29:36 TB Alliance

March 24 is World Tuberculosis Day. To mark the occasion, we have conversations with Christopher Fox, senior vice president, formulations, at the Access to Advanced Health Institute; TB Alliance CEO Mel Spigelman; and Jane Theaker, CEO of PBD Biotech.

This episode of the podcast is sponsored by Samplix.

World Tuberculosis Day

Tuberculosis is a leading infectious disease. 

According to the WHO, 10.6 million people became ill with the disease in 2021, and there were 1.6 million deaths from tuberculosis. The theme for World TB Day 2023 is Yes! We can end TB!

It aims to inspire hope and encourage high-level leadership, increased investments, faster uptake of new WHO recommendations, adoption of innovations, accelerated action, and multisectoral collaboration to combat TB. 

TB Alliance

TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. 

Through innovative science and with partners around the globe, the organization aims to ensure equitable access to faster, better TB cures that will advance global health and prosperity. 

TB Alliance operates with support from various global governments as well as the Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, the Global Health Innovative Technology Fund, and the United States Agency for International Development. 

Access to Advanced Health Institute

A potential new vaccine for tuberculosis has been developed by the Access to Advanced Health Institute in Seattle, a nonprofit biotech research institute.

The results of a phase 1 clinical trial were published earlier this month in the journal Nature Communications.

PBD Biotech

PBD Biotech has developed a rapid screening blood test for identifying people with the disease as well as a subgroup with pre-clinical infection at higher risk of developing the disease.

The company said this has the potential to revolutionize the management of TB. 

Biotech’s Actiphage blood test is sensitive and specific, and clinical studies at the Leicester Respiratory NIHR Biomedical Centre have shown it is able to diagnose patients with pulmonary TB and identify contacts with recent exposure that have very early stage infection and may be at higher risk of developing TB in the future. 

By enabling rapid screening of a population for TB, Actiphage offers a breakthrough in disease prevention and treatment. Further trials of Actiphage are currently running in the U.K., South Africa and Zambia.

Beyond Biotech podcast 38: Hello Tomorrow Global Summit17 Mar 202300:35:24

1:27 Labiotech.eu news
2:38 Allogenica
12:06 Helex
15:51 FreezeM
19:55 MediSieve

The Hello Tomorrow Global Summit took place in Paris last week (March 8-10), and we feature interviews with four of the participants.

Our guests this week are: FreezeM CEO and co-founder, Dr. Yuval Gilad; Allogenica CEO and co-founder Inna Menkova; George Frodsham, founder and CEO of MediSieve; and Poulami Chaudhuri, co-founder, and CEO of Helex Bio.

Hello Tomorrow

The 8th edition of the Hello Tomorrow Global Summit 2023 welcomed more than 3,000 people to the forefront of deep tech. There were hundreds of meetings, presentations and exhibitors in attendance, showcasing science in action - including many biotech and biopharma companies.

The Grand Winner of the Hello Tomorrow Global Challenge 2023 was Sweetch Energy, but a biotech company came in third, Allogenica. 

Allogenica also won the Medical Biotech & Pharmaceuticals category.

Allogenica

Created in January 2022, Allogenica is a French-headquartered startup developing universal cell therapies to treat certain forms of blood cancer (leukemia, lymphoma). 

It recently completed its first fundraising of €500,000 ($530,000) in order to continue its development towards an approach to industrializing the process. 

The startup, led by Inna Menkova, and assisted by PULSALYS, aims to offer a ready-to-use, less expensive and safer treatment, in order to treat more patients with blood cancers.

Helex

Helex, based in India, is a biotech with a platform built on proprietary bioinformatics and AI powered systems to identify unique sequences on the gene. The pre-clinical stage biotech company unlocks epigenetics and 3D genome structures through data and machine learning to design high precision gene-editing systems.

The company’s platform enables the design of appropriate gene editing apparatus. It prevents editing in unwanted tissues in cases of vector biodistribution through a Double Lock Safety system - tissue-specific vector modifications (first lock) combined with Hele-GUIDE tissue specific guide RNA (second lock) for greater safety. 

MediSieve

MediSieve is a U.K.-based start-up that has developed magnetic blood filtration, a platform therapy that enables the physical removal of specific substances from the bloodstream of patients. It can be used as a direct treatment, to increase the safety and efficacy of other therapies, or to enable personalized medicine. 

The company is a spin-off from University College London.

FreezeM

FreezeM is an Israel-based company founded in 2018 that provides insect breeding and post-breeding solutions. 

FreezeM has developed cutting-edge biotechnology centered on black soldier fly (BSF) breeding, helping to increase alternative protein production capacity for livestock, while at the same time salvaging scarce global farmland, decreasing ocean exhaustion, and repurposing organic waste. 

The company is reducing costs by an estimated 30% and increasing protein production capacity and efficiency by 25%. Most recently, FreezeM has been selected to join the Google Startups for Sustainable Development Program, has been ranked by Dealflow as a company to watch in the industry and raised €6.3 million in European Innovation Council (EIC) funding.

Beyond Biotech podcast 37: Natural killer cells, biopharma revenue, toxic shock syndrome vaccine09 Mar 202300:35:28

 1:19 Labiotech.eu news
2:32 Biomedical Research & Bio-Products
12:15 Model N
21:39 Institute of Clinical Medicine

This week our guests are Marit Inngjerdingen from the Institute of Clinical Medicine in Norway; Kyle Forcier, senior director of life sciences product marketing at Model N; and Dr. Andreas Roetzer, head of R&D for vaccines at Biomedical Research & Bio-Products.

The next breakthrough in cancer treatment?


In our body, we have an innate immune system and an immune system that is developed throughout life. Part of the innate immune system consists of so-called NK (natural killer) cells. 

This is a type of immune cell that specializes in killing cancer cells. These cells may be of great importance for cancer treatment in the future. NK cells kill cancer cells with the help of small “killer torpedoes,” or vesicles, that the NK cells secrete. 

Vesicles are small bubbles with a fatty wall of lipids and a space filled with toxic proteins. 

Researchers at the Institute of Clinical Medicine in Norway have recently discovered new things about these killer vesicles.

“We have discovered that we can separate the killer torpedoes from other types of vesicles so that they form a kind of arsenal of weapons. Our research also shows that this type of vesicle is probably stored in a separate room inside the NK cell,” Miriam Aarsund Larsen said.

Model N publishes revenue report

Model N, Inc. recently announced the results of its fifth annual State of Revenue Report. The report captures detailed data intended to help life sciences and high-tech industry executives grappling with how to grow company revenue and market share. Most executives named inflation as a significant headwind, with 84% calling it the single biggest impact on innovation.

“Our findings show three main themes: Innovation collides with current market realities, innovation directly impacts revenue management, and the use of technology for revenue management is expanding,” said Suresh Kannan, chief product officer, Model N. 

“As organizations continue to navigate the current economic climate, the quality and reliability of technology solutions are more important than ever. These insights help us understand how to empower our customers to create and bring life-changing products to market.”

Phase 2 study of breakthrough vaccine against toxic shock syndrome successfully completed

The first vaccine to potentially prevent Staphylococcal-induced toxic shock syndrome (TSS) has successfully completed a phase 2 study. TSS is a life-threatening condition caused by toxins that can lead to multiple organ failure and death.

Nosocomial pathogen Methicillin-resistant Staphylococcus aureus (MRSA) bacteria are resistant to widely used antibiotics. Infections with MRSA are harder to treat and therapies are more expensive as the length of hospital stays is significantly prolonged. If the treatment does not lead to rapid clearance of the bacterial pathogen, dangerous symptoms such as septic or toxic shock can occur – a potentially life-threatening condition.

Researchers at Biomedical Research & Bio-Products AG, under the direction of Martha Eibl, in cooperation with MedUni Vienna’s Department of Clinical Pharmacology, conducted the study. The promising results showed the TSST-1 vaccine is safe and effective, with immunization lasting for at least two years. 

Beyond Biotech podcast 36: Bio-Europe Spring and Cellular Origins03 Mar 202300:44:52

1:41 Labiotech.eu news
3:41 Cellular Origins
20:17 Bio-Europe Spring

Two of the interviews on the podcast today are related to Bio-Europe Spring. There are conversations with Rosie Bernard, senior director, production and content strategy for EBD Group EU, with an overview of the event, and also Jordan Stillman, project manager, partnering services at EBD Group.  We also have a chat with Cellular Origins' CEO Edwin Stone. 

Cellular Origins

Cellular Origins is a TTP spin-out, created to enable scalable, cost-effective and efficient manufacture of cell and gene therapies. Cellular Origins’ proprietary technology addresses the current barriers associated with the manufacture of advanced therapies that are in late-stage development, enabling commercial manufacturing without process change. 

By providing a solution for automated sterile fluidic interconnection that has the flexibility to adapt and link current and future bioprocess equipment, Cellular Origins hopes to enable full automation of current cell therapy manufacturing and future innovation of new processes.

Bio-Europe Spring

Bio-Europe Spring takes place March 20-22 in Basel, Switzerland. There is a virtual component for those unable to make the event, or who still have leftover meetings to schedule, and the online portion takes place from March 28 to 30.

The event, at the Messe Basel, is an opportunity to engage in face-to-face meetings with representatives of hundreds of companies from around the world. The partneringONE tool allows meetings to be set up, and to find information on companies and attendees.

As well as networking, there are exhibitors, receptions, and a variety of presentations. There is also a startup spotlight section. This year, the keynote presentations are being given by Roche and Novartis.

Currently, there are more than 3,200 attendees expected to be in Basel and 18,000 meetings are being requested weekly. More than 1,600 companies will be represented, from more than 50 countries.

Bio-Europe Spring sees companies from a variety of sectors, including products, services, and technologies. 

Beyond Biotech podcast 35: Rare Disease Day24 Feb 202301:01:06

0:58 Labiotech.eu news
2:37 Replay
23:45 Azafaros
39:39 GRO Biosciences

As February 28 is Rare Disease Day, we have three guests on the podcast today all relevant to rare diseases. And they are Dan Mandell, CEO and co-founder of GRO Biosciences; Stefano Portolano, chief executive officer, Azafaros; and from Replay, Adrian Woolfson, executive chairman, president, and co-founder, and Lachlan MacKinnon, CEO and co-founder.

Rare Disease Day

Taking place on February 28 each year, the event raises awareness and looks to generate change for the 300 million people worldwide living with a rare disease, as well as their families and carers.

This year, the day will be marked by more than 600 events in 106 countries.

Replay and The University of Texas MD Anderson Cancer Center create Syena

Replay, a genome writing company reprogramming biology by writing and delivering big DNA, and The University of Texas MD Anderson Cancer Center, have launched Syena, a new oncology-focused product company pioneering T-cell receptor (TCR) natural killer (NK) cell therapies (TCR-NKs).

Building on the intellectual property and technology from MD Anderson and Replay, Syena has the potential to create the next generation of cell therapy.

Azafaros

Azafaros is a clinical stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms, and a compound library from Leiden University. 

Its aim is to build a pipeline of disease-modifying therapeutics to offer patients and their families new treatment options. The company’s lead clinical-staged program is AZ-3102, a small molecule, orally available, brain penetrant azasugar, with the potential to treat GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) and Niemann-Pick disease type C (NP-C). 

This week, the company announced it has been granted two Rare Pediatric Disease Designations (RPDD) by the United States Food and Drug Administration (FDA) for the treatment of GM1 and GM2 gangliosidoses, Orphan Medicinal Product Designation (OMPD) by the European Medicines Agency (EMA) for the treatment of GM2 gangliosidosis, and an Innovation Passport by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of GM1 and GM2 gangliosidoses.

GRO Biosciences

GRO Biosciences is leveraging groundbreaking science to expand the amino acid alphabet and deliver on protein therapeutics. 

The U.S. company is transforming treatments for increasingly prevalent chronic medical conditions including autoimmune and metabolic diseases to improve the lives of patients. GRObio is applying its platform to advance partnered and collaborative programs, as well as its own pipeline of protein therapeutics bearing unique NSAA (non-standard amino acid) chemistries. 

The company’s NSAA therapeutics feature previously unattainable capabilities including unprecedented duration of action and precise regulation of the immune system.

Beyond Biotech podcast 34: eClinical Solutions, GPCR Therapeutics, Orbsen Therapeutics17 Feb 202300:58:35

1:25 Labiotech.eu news
3:02 GPCR Therapeutics
22:16 eClinical Solutions
31:04 Orbsen Therapeutics

This week, our guests are Katrina Rice, chief delivery officer, biometrics services at eClinical Solutions; Pina Cardarelli, president and CSO of GPCR Therapeutics; and Larry A Couture, CEO of Orbsen Therapeutics.

GPCR Therapeutics launches multiple myeloma trial 

GPCR Therapeutics, Inc., a drug discovery company targeting G Protein Coupled Receptors (GPCR) pairs, recently started its phase 2 trial in the U.S. for its lead small molecule asset, GPC-100.  GPC-100 targets CXCR4, one of the most prevalent chemokine GPCRs overexpressed in more than 23 cancers.

This randomized, open-label phase 2 study assesses the efficacy of GPC-100 and propranolol, with and without granulocyte colony-stimulating factor (G-CSF) for the mobilization of stem cells in patients with multiple myeloma undergoing autologous stem cell transplant. 

Survey looks at biotech challenges

eClinical Solutions, a provider of digital clinical software and biometrics services, has published a survey detailing insights from 60 biopharmaceutical clinical operations and biometrics professionals on the most pressing trends, challenges, and opportunities that are shaping the clinical data landscape. 

Some key takeaways include: 64% of respondents are leveraging 6 or more external data sources; harnessing automation is the top overarching industry priority for more than one-third (36%) of respondents; and speed (30%) and quality (30%) are reported as the largest pain points for electronic data capture (EDC) database build.

Orbsen Therapeutics

Orbsen Therapeutics is an Irish-headquartered company working in stromal cell immunotherapy. The company has leveraged its proprietary technology platform, which is based on highly purified stromal stem cells, to establish a specific portfolio of early-stage product candidates. 

Orbsen's allogeneic or 'off-the-shelf' cell product candidates target significantly advanced stages of diseases where there are high unmet medical needs, including moderate-severe acute respiratory distress syndrome (ARDS), autoimmune disease and Stage 3 DKD.



Beyond Biotech podcast 33: Astellas Pharma, Innovation Agency Lithuania, 4BaseBio10 Feb 202300:45:18

1:10 Labiotech.eu news
2:50 Innovation Agency Lithuania
25:25 Astellas Pharma
34:37 4basebio

This week, our guests are Romualda Stragienė, director at Innovation Agency Lithuania and Andrius Sliuzas, export key account manager of high tech industries at Innovation Agency Lithuania; 4basebio CEO Heikki Lanckriet; and Yoshitsugu Shitaka, chief scientific officer at Astellas.

4basebio

4basebio, a spinout of 2Invest AG in 2020, is a life sciences company engaged in the design, manufacture and supply of application-specific synthetic DNA or mRNA, as well as targeted non-viral vectors for the delivery of nucleic acid payloads, for use in cell and gene therapies and vaccines.

As cell and gene therapies expand, there is an increasing demand for DNA as a therapeutic agent and in the manufacture of mRNA. Existing plasmid DNA supply is produced by way of biofermentation. Synthetic DNA, in contrast, is produced in a matter of weeks using an enzymatically-driven bench top process. 4basebio currently produces four types of DNA constructs, which also offer unique application-specific flexibility and benefits.

4basebio is also developing non-viral delivery technology to overcome some of the challenges associated with commonly used viral vector and LNP (lipid nanoparticle) solutions.

Lithuania

Despite its small population of fewer than 3 million people, the Baltic country Lithuania punches above its weight in the life sciences. A major outlet of the Thermo Fisher Scientific is based in its capital city, Vilnius, for example. And the Life Sciences Center at Vilnius University was added to the European Molecular Biology Laboratory network in 2020, opening the door to major EU investments into biotech research in the center.

 More than 400 companies are working in Lithuania’s growing life sciences sector, and the space is growing every year. 

Astellas Pharma

Astellas Pharma Inc. is a Japanese-headquartered pharmaceutical company conducting business in more than 70 countries around the world. It utilizes its ‘Focus Area Approach,’ which is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs.

The company recently committed to achieve net zero greenhouse gas emissions by 2050.

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Talking about Alzheimer's disease: current drugs, clinical trials, and the pipeline09 Feb 202300:46:54

Sometimes, there’s an interview that’s just a bit long for the regular podcast. So we’re going to start an occasional series of podcasts where we look a bit more in depth at a condition, and what’s the current state of affairs in treatment. In this podcast, the first, we take a closer look at Alzheimer’s disease with a conversation about current drugs, clinical trials, and the pipeline.

Our guest is Sharon L. Rogers, CEO of the biotech AmyriAD Therapeutics.

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Beyond Biotech podcast 32: Cancer Research Horizons, Enterome, OncoHost, TrakCel, Turbine03 Feb 202301:11:10

01:38 Labiotech.eu news
03:18 OncoHost
18:13 Enterome
41:04 TrakCel
55:51 Cancer Research Horizons/Turbine

Our guests are Ofer Sharon, CEO of OncoHost; Matthew Lakelin, co-founder, TrakCel; Pierre Belichard, CEO of Enterome; and Tony Hickson, chief business officer for Cancer Research UK and Cancer Research Horizons and Daniel Veres, chief science officer and co-founder, Turbine.

World Cancer Day

February 4 is World Cancer Day. This year, the theme is Close the Gap. For the podcast this week, we feature four interviews related to cancer.

TrakCel

TrakCel is a developer of integrated technologies to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. 

TrakCel's software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. Its solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. 

Cancer Research Horizons and Turbine partnering

Cancer Research Horizons, the innovation engine at the core of the world’s largest private funder of cancer research, Cancer Research UK, is partnering with Turbine AI, a tech-enabled biotech leveraging its proprietary Simulated Cell platform to solve complex diseases.

The partnership will utilize Turbine AI’s platform to identify target patient populations who could benefit from CDC7 inhibitor therapy with Cancer Research Horizons’ lead compound CRT’2199.

CRT’2199 originates from Cancer Research Horizons’ Therapeutic Innovation. CDC7 is a protein that plays a vital role in the regulation of cell division in normal cells. However, dysregulation of CDC7 can lead to the formation of cancer cells, and overexpression of this protein is correlated with poor clinical prognosis in diverse cancers of significant unmet patient need.

Enterome

Enterome is a French clinical stage company developing off-the-shelf, transformational cancer treatments targeting all tumor types. Phase 2 trials for its most advanced program EO2401 have shown promising efficacy in recurrent glioblastoma and adrenal malignancies and good safety in more than 130 patients.

Enterome’s OncoMimics approach generates a long-lasting immune response from the patient’s own effector memory T-cells, overcoming the immune tolerance to self-antigens.

OncoMimics is a pipeline of immunotherapies made of a specific combination of bacterial peptides, derived from bacteria present in the gut microbiome, that closely mimic either overexpressed tumor-associated antigens (TAAs) or lineage-specific markers in solid and liquid tumors, respectively. 

These provide faster, stronger and durable immune responses, have excellent immunogenicity and can counteract tumor heterogeneity.

OncoHost launches PROphet NSCLC test in the US 

OncoHost, a precision diagnostics company centered on predictive biomarker development for improved patient care, has launched its PROphet non-small lung cancer (NSCLC) test in the U.S.

PROphet NSCLC, guides first line treatment decisions for advanced unresectable non-small lung cancer patients. It provides clinicians with actionable clinical insights into optimal first line therapeutic choices, and a better understanding of their patients’ personalized cancer dynamics. Requiring just one pre-treatment blood test, PROphet scans approximately 7,000 proteins in a patient's blood plasma and delivers a report that predicts their clinical benefit from anti-PD-1/PD-L1 immunotherapy-based treatment plans.

Meatly's innovative cultivated meat is already delighting pets, are humans next? 01 Aug 202500:38:45

Is cultivated meat the future of pet food? And is there a place for cultivated meat on human dinner tables, too?

Traditional agricultural methods are slow, require large tracts of land, significant energy and environmental inputs, and – somewhat obviously – the slaughter of hundreds of millions of animals every year. Cultivated meat – that is meat that is grown in a lab – requires little land, less energy, and in the case of Meatly, nothing more than a single cell from a single chicken egg, once. 

This week I sat down with Owen Ensor, CEO of UK biotech startup Meatly, to talk all things cultivated meat. He explains the science behind his company’s cultivated meat process, the significant cost savings that Meatly has made to bring down prices for their product, and how his company became the very first in Europe to have a cultivated meat product approved for sale, in the hands of consumers, and in the bellies of beloved cats and dogs.

01:29               Meet Owen Ensor

05:10               Meatly and its mission

10:12               The science of cultivated meat

19:41               Common criticisms of cultivated meat

25:33               Regulation, and geographical diversity in regulation

32:24               Looking forward: from pets to human consumption?

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Beyond Biotech podcast 31: Orgenesis, Phacilitate, Terumo, University of Birmingham, VIVEBiotech27 Jan 202300:48:49

01:22 Labiotech.eu news
03:03 Phacilitate/Advanced Therapies Week
14:15 Orgenesis
25:18 Terumo
31:47 VIVEBiotech
38:33 University of Birmingham

Phacilitate’s Advanced Therapies Week took place last week in Miami Beach, Florida.

This week, we speak with the organizers, as well as some of the companies in attendance.

Our guests are Kim Barnes, EVP, Phacilitate; Kathie Schneider, director and global commercial lead at Terumo; Vered Caplan, CEO, Orgenesis; Ivan Wall, head of the Centre for Advanced Therapies Manufacturing Training, University of Birmingham; and Natalia Elizalde, business development director, VIVEBiotech.

Phacilitate

Phacilitate stages two major events each year, Advanced Therapies Week, which took place from January 17 to 20 in Miami Beach, Florida, and Advanced Therapies Europe 2023, which takes place in Estoril, Portugal on September 6 and 7.

The company also provides market intelligence and hosts a variety of webinars.

Orgenesis

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. 

Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for the therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Its POCare Network unites patients, doctors, industry partners, research institutes, and hospitals worldwide to achieve harmonized, regulated clinical development and production of therapies. 

Terumo

Terumo is a global provider of medical technology. Based in Tokyo, it provides medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. 

University of Birmingham

The Centre for Advanced Therapies Manufacturing Training is a newly established National Training Centre based in Birmingham, U.K. It is one of several centers that form the Advanced Therapies Skills and Training Network, which is coordinated by the Cell and Gene Therapy Catapult. Its aim is to provide training to U.K. advanced therapy and vaccine manufacturers, to enable rapid and sustainable workforce growth.

VIVEBiotech

VIVEBiotech is a Spanish developer and manufacturer of lentiviral vectors working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including hematological and solid cancers, and rare diseases.

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Beyond Biotech podcast 30: Advanced Therapies Congress, BioAlps, Bionter, C2i Genomics 20 Jan 202301:00:57

02:29 Labiotech.eu news
04:11 C2i Genomics
22:31 Advanced Therapies Congress
31:37 BioAlps
47:29 Bionter
54:06 JLL

The guests on our podcast this week are: Jessica Robinson, project director, Advanced Therapies Congress, Terrapinn: Tobias Werk, CEO, Bionter; Asaf Zviran, CEO and co-founder of C2i Genomics; and Magali Bischof, secretary general of BioAlps.

We also have our weekly commentary from Travis McCready at global commercial real estate services company JLL.

This week’s podcast is sponsored by Bionter, a Swiss-based premier supplier of analytical testing solutions to support Pharma companies to bring drugs faster and safer onto the market. Their first product is a fully automated particle testing device for parenteral drug applications that is cost-efficient and compliant with current regulations. If you want to know more, go to www.Bionter.com.

C2i Genomics Announce Successful Evaluation of Whole Genome-Based Residual Disease Test Across Multiple Solid Cancer models

C2i Genomics, a cancer intelligence company, recently announced an extension of a collaboration with AstraZeneca. 

The two companies have collaborated to evaluate the potential of whole-genome minimal residual disease (MRD) testing across solid cancers, with the goal of enhancing oncology treatment, supporting clinical trial recruitment, and monitoring. 

C2i genomics has completed AstraZeneca’s BeyondBio Innovation Hub’s program for Israeli start-ups. Using artificially generated samples to reproduce varying levels of circulating tumor DNA (ctDNA) expected to be found in tumors, this collaboration provided early evidence that the C2i assay can sensitively detect ctDNA (down to 0.002% allelic frequency). Building on this work, AstraZeneca will further evaluate and validate the C2i Genomics platform across a panel of patient-derived samples using their in-house sequencing capabilities and expertise.

The non-invasive detection of circulating tumor DNA (ctDNA) from plasma has been shown to have clinical value for the detection of Minimal Residual Disease (MRD), the emergence of resistance, and the prediction of treatment response. New MRD technologies aim to provide greater cancer detection sensitivity by expanding methods beyond small, personalized panels. 

C2i Genomics’ MRD technology applies whole-genome sequencing and artificial intelligence to a small blood sample to provide ultra-sensitive cancer detection. This technology aims to eliminate the need to develop a patient-specific assay, enabling high-performance, personalized monitoring and rapid turnaround across multiple solid cancers with reduced operational complexity.

Advanced Therapies Congress

The Advanced Therapies Congress is Europe’s largest cell and gene therapy conference and exhibition. 

Presented by Terrapinn, the event is for the leaders of the world’s ATMP developers and their most senior executives in charge of the latest tech and strategies driving the industry forward. 

The event takes place on March 14 and 15 at the ExCeL in London.

BioAlps

BioAlps is the life sciences cluster covering western Switzerland.

It comprises an ecosystem of research institutions, academic institutions, startup companies and large multinationals concentrated in a small,  geographic area.

Its aim is to promote western Switzerland as a world class centre for life sciences and to foster growth by creating synergies between academia, entrepreneurs, investors, authorities and new businesses. It offers a networking and support opportunities through regional, national and international events, while promoting BioAlps on the global stage.

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Beyond Biotech podcast 29: Janssen, Knowledge Gate12 Jan 202300:29:40

1:03 Labiotech.eu news
2:34 Knowledge Gate
10:59 Janssen Scientific Affairs

This week, our guests are Viktoriya Vasilenko, Knowledge Gate co-founder and CEO; and Avery Ince, vice president, medical affairs, cardiovascular & metabolism at Janssen Scientific Affairs.

Study confirms benefit of XARELTO (rivaroxaban) for secondary prevention of venous thromboembolism in cancer patients

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor XARELTO (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. 

Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.

Data from the observational study in cancer-associated thrombosis for rivaroxaban (OSCAR) found XARELTO showed non-inferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalization for treatment of patients with CAT. 

Janssen said the study adds to the evidence for XARELTO, with more than 300,000 patients having been evaluated since its initial approval in the U.S. in 2011.

VTE occurs when a blood clot forms in a vein, affecting between 300,000 to 600,000 Americans each year, commonly triggered by surgery, cancer, immobilization and hospitalization. VTE is a common cause of morbidity and mortality, and people with cancer are at a higher risk for developing VTE than people without cancer.

Cancer is known to increase the risk of VTE, with cancer patients having a four to seven times increased risk of developing VTE. These patients also have a higher risk of recurrent VTE and of bleeding.

Previous studies such as SELECT-D and CONKO-11 demonstrated that changing from a low molecular weight heparin (LMWH) to XARELTO was associated with a reduction in risk of recurrent thrombosis and improved patient satisfaction.

Knowledge Gate

Knowledge Gate Group provides a key opinion leader online platform. Based in Copenhagen, Denmark, the company bridges the gap between businesses and life science experts. 

The artificial intelligence platform connects those looking to innovate with the key opinion leaders who can provide valuable insights. 

It covers a broad range of therapy area experts in the life sciences, and features automated management of all contractual, compliance and confidentiality requirements.

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