Beyond Biotech - the podcast from Labiotech – Details, episodes & analysis

Tumor infiltrating lymphocyte (TIL) therapy uses a person’s own immune cells to fight advanced melanoma, offering new hope for patients who have limited treatment options. 

This week, we have a conversation with Brian Gastman, EVP of medical affairs at Iovance Biotherapeutics, about TILs and the company’s pipeline.

Iovance recently submitted a marketing authorization application to the European Medicines Agency for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. 

If approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union member states.

The submission is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma.

Iovance’s Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. 

00:47-04:44: About Iovance Biotherapeutics
04:44-07:57: What is polyclonal tumor infiltrating lymphocyte treatment?
07:57-14:55: What is the production process for TILs?
14:55-18:32: Are there any limiting factors for TIL treatment?
18:32-20:59: Is early intervention important?
20:59-21:22: Does better psychology help?
21:22-22:06: Are other companies working on TILs?
22:06-27:25: Clinical trials 
27:25-29:25: How do you address cost?
29:25-34:21: Iovance’s pipeline
34:21-35:30: Can TILs be improved?
35:30-37:21: Where does the TIL space go from here?

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The development of combination vaccines could represent a significant advancement in the fight against infectious diseases. With the potential to streamline the vaccination process and provide broader protection, these vaccines could greatly improve public health preparedness.

Moderna is harnessing the power of its mRNA platform to develop vaccines that target multiple respiratory viruses at once, including COVID-19, RSV, and influenza. The breakthrough technology enables the immune system to combat multiple pathogens simultaneously, revolutionizing immunization efforts and enhancing public health preparedness.

To look at combination vaccines, their usefulness and potential for the future, we had an in-depth conversation with Cesar Sanz Rodriguez, vice president, Europe & Switzerland, medical affairs, at Moderna.

00:45-02:53: What is combination vaccine technology?
02:53-05:33: What are the advantages of targeting multiple respiratory diseases simultaneously?
05:33-06:02: Making vaccinations more friendly
06:02-07:57: How does the immune system handle tackling many pathogens at the same time?
07:57-10:23: Is there an effect of efficacy with combination vaccines?
10:23-12:50: How do you manage different times between boosters?
12:50-13:57: Are many companies working on combination vaccines?
13:57-17:45: How easy is it to add vaccines, for example to tackle avian flu, into combination vaccines?
17:45-19:06: Is there a limit to the number of vaccines in a combination vaccine? 
19:06-20:46: How easily can vaccines be updated to address variants?
20:46-22:30: What is the future of combination vaccines?
22:30-23:56: What is in Moderna’s pipeline related to vaccines?

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To learn more about the topic: 

• From pandemic spotlight to post-COVID crossroads: What happened to these biotech players?

US-based biotech company Priovant Therapeutics is dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. 

The company's lead asset, brepocitinib, is a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL6, IL12, and IL23—with a single, targeted therapy. 

Brepocitinib has generated positive data in seven phase 2 studies with oral once-daily administration. It is currently being evaluated in a phase 3 program for dermatomyositis and is entering a phase 3 program for non-infectious uveitis.

This week on the podcast we have a conversation with Priovant’s CEO Benjamin Zimmer about dermatomyositis, non-infectious uveitis, current treatments, potential options, and how brepocitinib is making a difference. 

00:55-02:34: About Priovant
02:34-06:38: What are dermatomyositis and non-infectious uveitis?
06:38-08:35: What are the current treatments?
08:35-12:32: What is brepocitinib?
12:32-15:36: Are there other treatments in development?
15:36-17:50: What is your relationship with Pfizer?
17:50-20:48: Brepocitinib clinical trials
20:48-24:06: Future plans and timeline
24:06-27:59: Finding patients for clinical trials
27:59-29:19: Future opportunities
 
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2:48 Labiotech.eu news
5:22 Gate Neurosciences
16:18 3Brain
31:13 Oncolyze
50:22 JLL

This week’s podcast guests are Mike McCully, CEO of Gate Neurosciences; Steven Evans, CEO and co-founder of Oncolyze; and Philipp Markolin, scientific marketing specialist at 3Brain.

We also have our weekly chat with global commercial real estate services company JLL, and this week it’s a chat with  Amber Schiada, head of life sciences research in the Americas for the company.

Gate launches to develop CNS treatments

Gate Neurosciences has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.

Gate, a U.S. biotech company, was founded in 2019 by a team of neuroscience industry veterans to address the need for more effective treatments for CNS disorders, and to overcome long-standing challenges in CNS drug development. 

Since its founding, the company has acquired a portfolio of next-generation compounds from large pharma, along with corresponding data from thousands of patients dosed across numerous clinical trials that will inform and de-risk future development.

Oncolyze set for AML clinical trials

After successfully completing in vitro and in vivo experiments, which support the notion that its lead drug candidate OM-301 breaks down cancer cells and increases survival rates, Oncolyze now has its sights set on advancing OM-301 into clinical trials.

Oncolyze has designed a novel anti-cancer drug (OM-301) that targets a particular cell surface protein. This protein, HDM2, is known to exist at high levels inside cancer cells and is thought to be an important driver of cancer growth and metastasis. More recently, though, it was discovered that HDM2 is also found on the cell surface of many types of cancer cells, but not normal cells.

3D microchip gives insights into human brain

A microchip that allows scientists to study the complexity of 3D cellular networks at unrivaled scale and precision has been added to 3Brain AG’s brain-on-chip portfolio.

In collaboration with Swiss precision manufacturing experts, CSEM, 3Brain AG made the announcement last month.

The cell-electronic interface technology will also allow scientists to gain novel mechanistic insights into the inner workings of the most complex structure in the universe, the human brain.


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2:15 Labiotech.eu news
5:12 Phase Genomics
16:44 IRB Barcelona
29:37 Ilya Pharma
43:00 Krystal Biotech
53:54   JLL

Our guests are Ilya Pharma CEO and co-founder Evelina Vågesjö and chief financial officer Oskar Lund; Miguel Martín-Álvarez, postdoctoral fellow in the cancer science unit at IRB Barcelona; Hubert Chen, head of clinical development at Krystal Biotech; and Ivan Liachko, CEO of Phase Genomics.

We also have a new weekly addition, as JLL will be joining us with a look at financial news. This week, we’re joined by Robert Coughlin, JLL managing director and New England Life Science Practice Group lead.

CRISPR allows the introduction of a desired DNA sequence into (virtually) any spot of the genome, thus modifying or inactivating a gene. The technique is widely used in biomedical research and some CRISPR-based therapies are in clinical trials for the treatment of human blood disorders, some types of cancer and HIV.

Scientists at IRB Barcelona, led by ICREA researcher Fran Supek, have now reported that, depending on the targeted spot of the human genome, CRISPR gene editing can give rise to cell toxicity and genomic instability. 

Ilya Pharma finalizes global patent coverage for modified lactic acid bacteria to treat wounds 

Ilya Pharma, a Swedish clinical stage biopharma company focused on delivering local immunotherapies to patients, has announced the issue of four new patents.

These are: one in India, and continuation patents in China, Australia and the U.S. This means the company’s method for using modified bacteria for treatment of both mucosal and cutaneous wounds in humans and animals has patent protection in all major markets.

Ilya is currently developing a portfolio of three first-in-class immunotherapies for skin and mucosal diseases, including ILP100-Topical for treatment surgical wounds in diabetic, prediabetic and obese patients especially at risk, ILP100-Topical for diabetic ulcers and ILP100-Oral for patients with immune mediated enterocolitis resulting from cancer treatment with checkpoint inhibitors.

Krystal Biotech gets green light for cystic fibrosis trial

U.S. company Krystal Biotech is set to start a clinical trial for cystic fibrosis after the United States Food and Drug Administration (FDA) accepted its investigational new drug (IND) application.

The gene therapy company will be evaluating KB407, a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs. 

By inducing expression of full length, normal CFTR protein in the lung, treatment with KB407 has the potential to restore ion and water flow into and out of lung cells to correct the lung manifestations of the disease in patients regardless of their underlying genetic mutation.

Phase Genomics using ProxiMeta for phage-bacteria interactions

Phase Genomics, Inc., a developer of proximity ligation-based genomic solutions, recently received $5.5M in combined non-dilutive funding from the Bill and Melinda Gates Foundation and the National Institute of Allergy and Infectious Diseases. With the new funding, Phase Genomics will leverage its phage-bacteria interactome repository to power the development of an  AI-driven predictive engine for therapeutic phage discovery.

The new financing will allow the company to harness its proximity-guided metagenomics platform, ProxiMeta, to develop the world’s largest atlas of phage-bacteria interactions and use machine learning tools to identify phages that can be used in therapeutic settings such as C. difficile infections, ulcerative colitis, and Crohn’s disease. 
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This week our guests on the podcast are Xianghao Zuo, deputy director of R&D at Triastek; Endpoint Health CEO Jason Springs; and Andy Whiting, CEO of Nevrargenics.

2:15 News
4:28 Nevrargenics
22:26 Triastek
37:14 Endpoint Health

Triastek and Lilly working together on 3D printing for drugs

A new research collaboration between Chinese company Triastek, Inc. and Eli Lilly and Company will leverage 3D printing technology to achieve precise targeting and programmed drug release in the intestine. 

Triastek has developed 3D printing technology to provide solutions for drug development. According to the agreement, Triastek and Lilly will focus on improving the bioavailability of drugs in the intestine. 

Triastek will first conduct in-depth studies of the excipient – inert ingredients added to a drug product for specific functional roles -- to ensure drug stability is maintained during development and 3D printing. Then, Triastek will identify the optimum 3D structure design for achieving targeted and programmed drug release.

Triastek has already received two investigational drug clearances from the U.S. Food and Drug Administration for its 3D printed drugs, T19 and T20. 

Endpoint Health receives funding for precision immunology pipeline

Endpoint Health, Inc., a therapeutics company dedicated to addressing unmet needs in immune-mediated acute and chronic diseases, recently recveived $52 million in equity and debt financing. 

Proceeds from the financing round are being used to extend the company’s Precision-First platform and expand its therapeutic pipeline to include programs for chronic immune-mediated diseases. 

In addition, proceeds will be used to advance Antithrombin III, the company’s first precision therapy, to a phase II clinical trial for the treatment of sepsis. The company expects to submit its Investigational New Drug application and Investigational Device Exemption to the US Food and Drug Administration for its Antithrombin III program later this year.

Completion of the Series A financing follows Endpoint Health’s announcement of a global collaboration and licensing agreement with Grifols to develop and commercialize Antithrombin III in sepsis.

Nevrargenics

Nevrargenics Ltd is a UK drug discovery and development company focused on innovative and novel medicines for neurodegenerative disease.

Developed through a commercial team, the research aims to bring a series of drug solutions to market and to service disease areas of major unmet need. The focus area of the company is the development of drugs to target neurodegenerative conditions.

Two research groups, based at Aberdeen and Durham universities, have been collaborating for several years, and through this collaboration, have designed, synthesized and identified a lead drug candidate with the potential for establishing new treatment approaches. 

The strategy is to employ new dual-acting retinoic acid receptor modulators (RAR-M) as the basis for developing a series of new rationally designed, effective treatments, meeting that most severe of unmet needs: neurodegeneration.

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This week's guests are ARCH Venture Partners’ managing director Kristina Burow; founder and CEO of Micropep Thomas Laurent; Kylie O’Keefe, SVP, commercial & corporate strategy at PTC Therapeutics, and Juan Carlos Jaramillo, chief medical officer of Valneva.

1:40 News
3:47 PTC
18:32 Micropep
33:01 Valneva
42:12 ARCH

ARCH Venture Partners closes $2.97B biotech fund

ARCH Venture Partners has announced the closing of ARCH Venture Fund XII, with $2.975 billion to invest in the creation, development and funding of early stage biotechnology companies. 

ARCH Venture Partners is one of the largest early-stage technology venture firms in the U.S. It invests primarily in companies it co-founds with leading scientists and entrepreneurs, bringing innovations in life sciences and physical sciences to market.

Upstaza gets EC green light

PTC Therapeutics, Inc. says Upstaza (eladocagene exuparvovec) has been given marketing authorization by the European Commission. 

Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency, and the first marketed gene therapy directly infused into the brain. It is approved for patients 18 months and older.

Upstaza also reduced symptoms that cause potentially life-threatening and morbid complications.

The marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.  

Micropep raises €8.75M to develop alternative crop-protection products

French ag-biotech company Micropep, which develops biological micropeptide-based solutions for agriculture, has completed an €8.75 million ($9.3 million) series A1 financing round. 

Based in Toulouse, Micropep has developed a technological platform that makes it possible to precisely regulate a plant’s gene expression, without altering its DNA, by the exogenous application of micropeptides, a family of proteins naturally produced by plants to respond to stress and regulate their development.

The new investment also marks the first step towards the commercialization of Micropep’s products. Micropep is using this funding to accelerate the development phase of its first micropeptide candidates in the U.S. and will build a locally-recruited team to deploy its solutions. 

Pfizer and Valneva to start phase 3 Lyme disease vaccine study

Pfizer Inc. and Valneva SE have initiated a phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” said Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer. 

Juan Carlos Jaramillo, chief medical officer of Valneva, said, “We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the northern hemisphere. We look forward to further investigating the VLA15 candidate in phase 3, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.”

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This week’s podcast guests are Laura Fletcher, head of business development and strategic partnerships at Deep Science Ventures; Matthias Steger, CEO of Endogena Therapeutics; Rodolphe Besserve, CEO, and Georges Rawadi, chief of biotech studio development, at eureKARE; and Biotech Growth Trust portfolio manager, Geoff Hsu.

News: 02:30
Endogena Therapeutics 5:10
eureKARE 21:00
Deep Science Ventures 33:46
Biotech Growth Trust 47:44

Endogena Therapeutics Inc. has announced the first patient has been treated in a phase 1/2a clinical study of its lead product, EA-2353, a photoreceptor regeneration treatment for retinitis pigmentosa (RP).

RP is a group of inherited diseases causing slow and progressive retinal degeneration and loss of vision, for which there is currently no treatment for most patients. It is a leading cause of inherited blindness, with an estimated 1.5 million people worldwide presently affected.

eureKARE, an investment company focused on financing and building next generation biotech companies in the fields of synthetic biology, has launched its first synthetic biology studio in Belgium. 

eureKARE is developing a pan-European biotech studio network covering several areas where synthetic biology can create solutions and high market value products.

The synthetic biology studios will focus on biomedical and other thematic applications in different European innovation hotspots. The strategy is based on identifying, selecting, and nurturing high-quality European science. 

The venture builder Deep Science Ventures (DSV) has expanded an existing alliance with Cancer Research UK’s innovation-focused arm Cancer Research Horizons, with the mission to establish new oncology startups in the U.K.

Just months after Cancer Research UK (CRUK) established its industry-orientated division Cancer Research Horizons, the research charity has doubled down on a collaboration with DSV, a U.K. venture builder operating in a range of sectors including biotech, agriculture and computation. 

According to the latest agreement, the partners will co-found startups working in up to 10 areas of oncology, such as improving the number of patients that can benefit from immuno-oncology treatments.

The Biotech Growth Trust PLC, based in the UK, seeks capital appreciation through investment in the worldwide biotech industry. It invests in a diversified portfolio of shares and related securities in companies on a worldwide basis.

Its portfolio is operated by U.S.-headquartered OrbiMed Capital LLC. 

Following the strong results of the previous year, the company’s NAV (net asset value) per share total return dropped by 33.8%, compared to a 55.1% increase in 2021, and the share price total return was down 37.0%. 

However, ​​overall, since OrbiMed’s appointment in 2005, and to the year end, The Biotech Growth Trust’s NAV has increased by 861.6% or 14.3% per annum.

In its annual report, the portfolio manager stated the company remains confident that there are a number of potential catalysts that could lead to a recovery in the biotechnology sector this year and into the future, and their overall investment strategy remains unchanged.

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This week's podcast features three interviews related to hepatitis.

Our guests are Ahmed Elsharkawy, consultant transplant hepatologist and honorary senior clinical lecturer at the University of Birmingham in the UK; Ziv Ben-Ari, director of the Liver Diseases Center at the Sheba Medical Center in Israel, and James McIlroy, chief executive officer at EnteroBiotix.

World Hepatitis Day

Taking place on July 28 every year, World Hepatitis Day unites the world under a single theme to raise awareness of the global burden of viral hepatitis with the intention of influencing real change. This year’s theme is ‘I Can’t Wait’.

Dr Ahmed Elsharkawy is a consultant transplant hepatologist and honorary senior clinical lecturer at the University of Birmingham and he is also chair of hepatitis B virus special interest group which is part of the British Association for the Study of the Liver. He is a strong supporter and advocate of World Hepatitis Day. 

Professor Ziv Ben-Ari is director of the Center for Liver Diseases and Liver Research Laboratory at the Sheba Medical Center in Israel and Professor of Medicine at Tel-Aviv University.

She has more than 25 years of experience in evaluating candidates for liver transplantation and monitoring liver transplants including five years as a fellow in Hepatology and Liver Transplantation at the Royal Free Hospital, London.  She has chaired the Israeli Liver Research Society, chairs the Liver Committee of the National Council of Gastroenterology and is an active member of the American and European Association for the Study of the Liver. She has published more than 175 studies in leading medical journals.

Dr James McIlroy is a qualified medical doctor and biopharmaceutical entrepreneur widely recognized as a pioneer and thought leader in the application of the microbiome to treat disease.

He founded EnteroBiotix with the vision of building one of the world’s leading microbiome drug development companies.

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On this week’s podcast, our guests are Jeremy Skillington, CEO of Poolbeg Pharma; Dani Bach, and Eric Moessinger, both partners at +ND Capital; and Louise Modis, chief scientific officer at Mogrify.

Poolbeg Pharma, a clinical stage infectious disease pharmaceutical company, has received ethics and competent authority approval to commence its lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza.

Biopharma company Mogrify Limited, and Japanese regenerative medicine firm Astellas Pharma Inc., have announced a collaborative research agreement on in vivo regenerative medicine approaches to address sensorineural hearing loss.

Belgian headquartered biotech Galapagos NV has acquired CellPoint and AboundBio, a move the Belgian company said propels it into next-generation cell therapy.

The deal saw the Lausanne-based team of US venture capital firm, +ND Capital, mark its second successful exit in the European biotech market. 

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