Afleveringen

  • Spinal cord injuries impact millions of people worldwide and, unlike many chronic injuries, they usually arrive with no forewarning, impacting the young and old alike.

    Brian Culley is CEO of Lineage Cell Therapeutics and his company is now in the clinic with a stem cell therapy for spinal cord injuries. Learn why stem cells could be promising for these devastating injuries and how Brian and his team plan to overcome the challenges of manufacturing at scale and succeeding in a highly regulated space.

    00:57 Meet Brian Culley

    02:15 Lineage Cell Therapeutics and its mission

    04:56 Spinal cord injuries

    06:40 Costs beyond the Individual

    08:15 Current treatment options

    10:48 The place for stem cell therapies

    12:57 Lineage in the clinic

    16:27 The DOSED program

    18:37 The advantages of DOSED

    20:29 Timelines for results

    21:35 Scaling manufacturing

    24:28 Partnering with pharma on stem cell therapies

    26:38 Other applications for stem cell therapies

    28:49 Mainstreaming stem cell therapies

    30:52 Challenges ahead

    32:43 The future for Lineage Cell Therapeutics

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  • Mitochondria are famously the powerhouse of the cell, but will mitochondrial therapeutics power the next big mainstream medical breakthrough?

    Klaus Dugi is CEO of Vandria, a biotech that develops mitophagy inducers that rejuvenate cells to treat age-related and chronic diseases. He joins 'Beyond Biotech' to talk cell mitophagy, biotech agility, and innovation in tackling neurodegenerative disease.

    00:42 Introducing Klaus Dugi

    02:51 Lessons learned in top pharma

    05:10 The gap that Vandria seeks to fill

    06:21 Mitochondrial therapeutics

    07:45 Mitophagy inducers and how they work

    14:53 Comparing approaches to treating neurodegenerative diseases

    17:20 Aging, longevity, and healthy life years

    25:26 Challenges ahead

    27:31 Performance enhancement and resilience

    31:15 Towards the mainstream?

    34:35 Looking forward for Vandria

    36:02 Developments to watch out for in mitochondrial therapeutics

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  • Regeneration Biomedical has developed a new technique to address neurodegenerative diseases like Alzheimer's using stem cell therapy.

    Dr. Christopher Duma, has long been an innovator in neurosurgery using a gamma knife radiosurgery to treat glioblastoma. Now with Regeneration Biomedical, Duma is taking on neurodegenerative diseases with a first-in-human clinical trial where a patient's own stem cells are injected directly into their brain.

    On the podcast this week, we talk with Duma about his career in neurosurgery, the impetus for launching his biotech, the promise of stem cell therapy, and the challenges innovators face moving new therapies through the clinic.

    00:38 Introducing Dr Christopher Duma

    02:44 Advances and breakthroughs in neurosurgery

    05:33 The vision and impetus for Regeneration Biomedical

    10:45 Regeneration Biomedical’s R&D pipeline

    14:12 Milestones ahead

    14:46 Advancing beyond Alzheimer’s Disease

    15:52 Stems cells from fat cells

    19:42 Bypassing the blood-brain barrier

    22:45 Patient recruitment

    24:13 The treatment process

    27:10 The state of stem cell research in the US

    29:29 The challenge of financing innovative research

    32:15 Global stem cell research landscape

    33:14 Controversy in stem cell research

    34:00 Future horizons for Regeneration Biomedical

    37:23 Partnering with top pharma companies

    37:48 Advice for researchers and entrepreneurs


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  • We’re taking a short break this week and, while we’re away, we invite you to enjoy one of our favorite episodes. We will return with a brand-new episode next week!

    Immunai is mapping the immune system at unprecedented scale and granularity. The map, paired with machine learning, looks at how the immune system will respond to drug targets, offering an affordable way to prevent expensive drug failures.

    The ultimate goal is to market immune treatments for diseases like cancer faster than ever before.

    In this week’s conversation, Noam Solomon, CEO and co-founder of Immunai, covers the data gap in drug discovery and how machine learning (ML) can solve it, how to de-risk early-stage drug discovery, predictions for AI, and more.

    00:49-01:13: About Immunai

    01:13-01:45: Why map the immune system?

    01:45-02:44: Are you taking a step back to study the problem in order to move forward?

    02:44-03:49: How difficult is it to map the immune system?

    03:49-05:29: What is your AMICA platform?

    05:29-07:24: Where does your data come from?

    07:24-09:09: How do you account for differences between patients?

    09:09-11:35: What are the biggest challenges to drug development?

    11:35-14:07: How can AI improve drug development?

    14:07-14:55: Will AI advances speed up drug development?

    14:55-16:06: Is the use of AI applicable in all diseases and conditions?

    16:06-17:48: What sets your approach apart from other companies using AI?

    17:48-18:54: What partnerships does Immunai have?

    18:54-20:24: What are pharma companies looking for from Immunai?

    20:24-23:17: How can AI help with clinical trials?

    23:17-24:32: Can AI help with preventative care?

    24:32-26:30: Google Maps for the immune system

    26:30-27:18: What will we see from AI in drug discovery in the short term?

    27:18-28:06: What are the next steps for Immunai?

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  • Sweden's fastest growing private biotech, Anocca, is making plans for clinical trials in pancreatic cancer, with the TCR-T cell therapy trials called VIDAR-1.

    The CEO, Reagan Jarvis, when a researcher, pitched the company idea to a leading Swedish industrialist, who became co-founder, and provided the initial financing.

    The company has raised more than €100m to date.

    On the podcast this week, we have a conversation with Jarvis about TCR-T cell therapies, creating off-the-shelf products and partnerships with EmendoBio and Shinobi Therapeutics.

    00:43-02:10: About Anocca
    02:10-04:16: About TCR-T cell therapies and their use in treatments
    04:16-06:02: Anocca’s approach to T-cell biology, cutting-edge biotechnologies and integrated software
    06:02-07:58: A different approach to other cell and gene therapy companies
    07:58-09:16: Facing challenges
    09:16-10:48: Addressing conditions and diseases
    10:48-11:54: Pancreatic cancer
    11:54-13:40: What represents success for Anocca?
    13:40-14:09: What is VIDAR-1?
    14:09-16:08: Partnerships
    16:08-18:05: Scaling up and addressing costs
    18:05-20:07: How is TCR-T therapy evolving?
    20:07-23:11: The impact of artificial intelligence
    23:11-25:16: Anocca timeline
    25:16-25:57: Closing comments
    `
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  • Resalis Therapeutics is pursuing a groundbreaking approach to obesity treatment.

    Unlike current therapies that primarily focus on appetite suppression, Resalis’ lead program, RES-010, is a non-coding RNA drug candidate that targets underlying biological pathways to promote sustainable weight loss.

    By enhancing energy expenditure through white-to-brown adipose tissue conversion while preserving muscle mass, RES-010 is positioned as an ideal standalone therapy or a synergistic option for long-term weight management.

    The company recently initiated a phase 1 study in December 2024 for RES-010 in healthy and obese subjects, and they also secured an equity investment from Sanofi in October 2024.

    To talk about ways to tackle obesity, and Resalis’ approach, our guest on the podcast this week is Alessandro Toniolo, CEO of Resalis Therapeutics.

    00:57-05:06: About Resalis Therapeutics
    05:06-08:59: Issues of obesity
    08:59-13:20: Companies working on obesity treatments
    13:20-15:34: Does suppressing appetite affect nutrition?
    15:34-17:49: Introduction of new obesity treatments
    17:49-21:33: Approaches other than appetite suppression
    21:33-22:38: RES-010 mode of action
    22:38-24:04: Administration methods
    24:04-25:11: Clinical trials
    25:11-26:38: Resalis’ pipeline
    26:38-28:08: Next steps for Resalis
    28:08-28:36: Effect of obesity on other parts of the body
    28:36-29:06: Final comments
    `
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  • CatalYm is preparing to initiate its broad phase 2b clinical development program for visugromab to tackle multiple solid tumor indications.

    Visugromab is a monoclonal antibody that neutralizes the tumor-derived growth differentiation factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance.

    Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation, proliferation and Interferon-γ signature induction.

    Visugromab has demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients, as highlighted in its recent Nature publication and interim clinical data.

    This week we have a conversation with Eugen Leo, chief medical officer at CatalYm.

    01:30-03:38: About CatalYm
    03:38-06:59: Solid tumors and also why they are hard to treat
    06:59-09:04: Current treatments for solid tumors
    09:04-10:47: What is immunotherapy resistance?
    10:47-12:23: What is visugromab?
    12:23-13:32: CatalYm’s clinical development program
    13:32-15:12: What represents success for patients using visugromab?
    15:12-17:50: Other treatment options being developed
    17:50-19:50: CatalYm’s pipeline and the future

    This week’s podcast was sponsored by TCR Solutions.

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  • In the fall of 2024, Haya Therapeutics, based in Switzerland and San Diego, landed a $1bn deal with Eli Lilly to apply its long non-coding RNA (ncRNA) technology to obesity.

    The company’s lead candidate, HTX-001, is making progress towards the clinic in cardiomyopathy. CEO Samir is one of the first researchers to publish on lncRNA – which is also known as the Dark Genome

    This week, our podcast guest is Samir Ounzain, CEO and co-founder of Haya Therapeutics. Ounzain was one of the first researchers to publish on lncRNA, also known as the ‘dark genome.’

    00:55-03:47: About Haya Therapeutics
    03:47-06:37: What is the dark genome?
    06:37-09:29: What is the connection between lncRNA and disease?
    09:30-13:22: How can disease be addressed via the dark genome?
    13:22-16:45: Which diseases are you tackling?
    16:45-18:02: What is the EchoHAYA platform?
    18:02-21:07: How does your lead candidate, HTX-001, work?
    21:07-22:00: Is the objective stopping fibrosis or reversing it?
    22:00-23:41: Other companies in the field
    23:41-24:52: Working with Eli Lilly
    24:52-27:15: A new frontier in medicine?
    27:15-28:43: Cost effectiveness
    28:43-30:07: Clinical trials
    30:07-31:48: Applications to other diseases

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  • Solid tumors present a big challenge for current treatments. However, a new approach might provide the answers - Tumor Activated Therapy.

    By targeting specific proteins common in all solid tumor micro-environments, Seekyo scientists think this can induce self-destruction of the tumor itself. Seekyo’s lead therapy, SKY01, can only be activated within the tumor, making it a highly-targeted solution.

    This differentiated approach overcomes the limits of existing treatments, such as small molecule or antibody-drug conjugates. It could also be more cost effective than many advanced, far cell and gene therapy alternatives.

    Seekyo is looking for clinical entry to target four of the more challenging solid cancers - pancreas, TNBC, colorectal and lung, in an umbrella PhI/IIa. This will demonstrate safety and initial efficacy readings whilst at the same time defining the lead indication to progress to later-stage development.

    This week, our guest is Seekyo Therapeutics’ CEO, Oury Chetboun.

    00:38-01:57: About Seekyo Therapeutics
    01:57-03:17: The challenges of treating solid tumors
    03:17-06:08: What is Tumor Activated Therapy?
    06:08-07:46: What is SKY01?
    07:46-08:10: What happens to the cancer cells?
    08:10-09:52: Does the tumor vanish?
    09:52-10:16: How is it delivered?
    10:16-11:30: Are other companies working on tumor-activated therapies?
    11:30-13:09: What treatment options are being worked on for solid tumors?
    13:09-13:47: Long-lasting treatment
    13:47-15:33: Clinical trials
    15:33-16:22: Timelines
    16:22-18:08: Does the treatment have other potential applications?
    18:08-19:59: Cost effectiveness
    19:59-21:59: Is the goal to cure people?
    21:59-22:46: Treatment frequency
    22:46-24:00: The impact of tumor size
    24:00-25:23: Seekyo Therapeutics’ pipeline
    25:23-27:27: Fund-raising
    27:27-30:33: Reaction to the therapy

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  • This week, we take a look at some of the highlights from the 43rd Annual J.P. Morgan Healthcare Conference, which took place in San Francisco recently.

    While there weren’t necessarily many financial blockbusters, there were plenty of announcements and discussions on everything from artificial intelligence to the rising influence of Chinese companies and research, to the potential ramifications of the incoming Trump administration in the U.S.

    To help us navigate some of the highlights of the event, we spoke with Orca Bio’s co-founder and CEO, Ivan Dimov, and also Parabilis Medicines’ chief business officer, Greg Miller.

    02:01-03:53: About Orca Bio
    03:53-05:43: JPM highlights
    05:43-07:26: Stand-out deals and announcements
    07:26-09:01: Were any sectors more prominent than others?
    09:01-12:38: About Parabilis Medicines
    12:38-13:58: JPM highlights
    13:58-16:33: Stand-out deals and announcements
    16:33-17:53: Were any sectors more prominent than others?
    17:53-19:17: Was there an optimistic mood?

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  • Jessica Owens and Iana Dimkova are co-founders of Initiate Ventures—a female-led venture capital firm and studio that launched recently with a $45 million debut fund.

    Initiate Ventures is shaking up the traditional venture capital model by blending investments in healthcare, life sciences, and technology with a company creation platform. The company is tackling some of the most pressing challenges in healthcare, and their innovative approach offers fresh insights into what it takes to scale transformative startups.

    Owens was the co-founder of GRAIL (acquired by Illumina for $8bn) and was a partner at Kleiner Perkins, where she helped shape some of the most successful health tech startups. Dimkova is a former healthcare technology investor at GE Ventures, who also scaled a company that raised more than $700m and built one of the largest radiation therapy networks in the US.

    Their approach is reflected in their dual model: funding existing companies while also co-creating ventures alongside founders in their startup studio. They helped launch groundbreaking companies like Macro Trials, a precision clinical research platform, and Persana, a leader in oncology diagnostics.

    This week on the podcast, we have a conversation with one of the co-founders of the company, Jessica Owens.

    00:40-05:19: About Initiate Ventures
    05:19-08:33: What sets Initiate Ventures apart from other venture funds?
    08:33-10:59: Revitalizing healthcare
    10:59-13:46: Determining realistic company visions
    13:46-15:15: Initiate Ventures and Initiate Studios
    15:15-19:50: Working with companies
    19:50-21:36: Working with new companies
    21:36-23:00: Evaluating potential success
    23:00-24:40: How hands on is Initiate Ventures?
    24:40-28:24: Is there a change in what attracts capital?
    28:24-30:02: Infectious disease – a neglected area
    30:02-33:08: How important are ESG considerations?
    33:08-35:42: Trends for 2025
    35:42-36:42: Goals for 2025

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  • Brixton Biosciences, a clinical-stage life sciences company spun out from Massachusetts General Brigham, has been awarded $2m from the NIH HEAL Initiative to support the development of non-opioid, injectable pain relief solutions.

    As part of the NIH's efforts to tackle the U.S. opioid crisis, the funding will advance research into safer, drug-free alternatives to opioid pain management. Brixton’s Neural Ice is an injectable, drug-free pain management technology designed to provide long-lasting relief from chronic and post-operative pain.

    On the podcast this week, we have a conversation with Sameer Sabir, CEO and co-founder of Brixton Biosciences, to dive deeper into pain treatment, the opioid crisis, and Brixton’s mission.

    01:05-02:47: About Brixton Biosciences
    02:47-03:39: Brixton’s pipeline
    03:39-07:46: The opioid crisis
    07:46-08:41: The extent of the crisis
    08:41-12:00: Current alternatives to opioids
    12:00-12:40: Managing pain
    12:40-17:19: How was Neural ice developed?
    17:19-18:33: Duration of treatment
    18:33-21:01: Suitability for different levels of pain
    21:01-21:31: Speed of effect
    21:31-22:37: Side effects
    22:37-24:18: Opioids vs. non-opioids
    24:18-25:33: Are there different responses to Neural Ice?
    25:33-26:29: Standardized doses
    26:29-27:42: Pricing
    27:42-28:49: Other work on alternatives to opioids
    28:49-30:45: Challenges to developing new pain treatments
    30:45-31:57: Other priorities at Brixton
    31:57-32:16: Timeline for Neural Ice

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  • While our podcast takes a brief break, Labiotech invites you to enjoy some of our favorite episodes. We will return with a brand-new episode on January 3rd, 2025! Have an awesome holiday season!

    On this podcast, 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 2023, 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.

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  • Our guest on the podcast this week is John Cassidy, director of life sciences and healthtech investments at SoftBank Vision Fund.

    Softbank Vision Fund is the world’s largest technology-focused investment fund, with $166bn assets under management, and a portfolio of more than 250 companies.

    In the discussion, we cover investment trends within life sciences, the European health and biotech scene, as well as the precise applications of new and emerging AI technologies. We also look ahead to what the biotech and life sciences fields may hold in 2025.

    00:55-02:03: About the SoftBank Vision Fund
    02:03-02:47: Developing timelines
    02:47-04:27: Managing a large portfolio
    04:27-11:18: Portfolio company profiles
    11:18-13:36: Investment criteria
    13:36-17:06: Trends in funding
    17:06-19:09: Effects of the US election
    19:09-21:45: How can companies reduce risk and raise funds?
    21:45-25:25: What sectors are attracting interest currently?
    25:25-27:49: Focusing on patients not profits
    27:49-29:53: The impact of AI
    29:53-31:45: Focus on applications
    31:45-35:24: Trends in European biotech funding
    35:24-38:19: Trends for 2025

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  • There is a constant risk of severe, potentially life-threatening allergic reactions for individuals with peanut allergies, which leads to significant physical, social, and emotional burdens.

    IgGenix, a clinical-stage immunology biotechnology company, recently announced the first patient dosed in its phase 1 trial evaluating IGNX001, a novel monoclonal antibody-based therapeutic, for peanut allergy.

    Designed to neutralize the most clinically important peanut allergens and epitopes, IGNX001 combats peanut allergies by blocking the allergic cascade and reducing risk of anaphylaxis.

    Should IGNX001 prove successful, it will provide a promising solution for peanut allergies and pave the way for IgGenix's technology to be applied to other types of food allergies and allergic diseases.

    Our guest on the podcast this week is Jessica Grossman, chief executive officer of IgGenix.

    01:14-02:51: About IgGenix
    02:51-06:30: About peanut allergy
    06:30-07:31: Are allergies on the rise?
    07:31-08:46: Are allergy responses similar?
    08:46-10:13: The problems with treating allergies
    10:13-13:53: Current treatments for peanut allergy
    13:53-15:45: The challenges of developing drugs to treat allergies
    15:45-16:54: Overcoming the placebo effect
    16:54-18:18: Are other companies working on allergy treatments?
    18:18-21:32: IgGenix’s SEQ SIFTER platform
    21:32-24:20: About IgGenix’s IGNX001
    24:20-24:42: Repeat doses
    24:42-26:19: Could peanut allergy sufferers eat peanuts?
    26:19-27:46: Can the technology be adapted to treat other allergies?
    27:46-28:56: Are there variations in the treatment of different allergies?
    28:56-29:35: Treatments for other diseases
    29:35-30:23: The future for people with allergies

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  • ambiom is a life science commercial-advisory business development company based in the Slovakian capital of Bratislava.

    The company helps its corporate clients with their product strategy, in- and out-licensing efforts, including asset valuation (NPV, rNPV), M&A scouting, complex due diligence and dealmaking.

    ambiom also provides input on regulatory matters, support in pricing and reimbursement decisions and communication with decision-making authorities. The company guides products from the beginning - the basic science - all the way to commercialization or spin-offs.

    Our guest on the podcast this week is the founder and CEO of ambiom, Adam Marťák. We discuss the biotech scene in eastern Europe, the company, and look at some of the challenges facing biotech companies as they navigate the financial pathway alongside drug discovery, regulations, and commercialization.

    00:45-02:33: About ambiom
    02:33-03:11: ambiom clients
    03:11-04:21: Biotech in eastern Europe
    04:21-11:35: Focusing on a niche
    11:35-13:13: What do startups need?
    13:13-15:19: How do you help startups?
    15:19-16:52: Tech transfer
    16:52-18:35: Early-stage and late-stage biotech valuations
    18:35-21:48: Different valuation methods
    21:48-22:53: Why do early-stage biotech valuations offer higher upside potential for investors?
    22:53-23:42: How do you measure the value of pipeline potential?
    23:42-24:35: Does a bigger pipeline guarantee more success?
    24:35-27:08: Can companies look more attractive to investors?
    27:08-28:41: Does pipeline speed affect investment?
    28:41-30:27: Which valuation method is better for biotech companies?
    30:27-31:46: Are some areas of biotech better for valuations?
    31:46-33:18: What affects valuation?
    33:18-35:13: The difference between financing of expensive and cheaper drugs
    35:13-36:57 : Is funding more difficult now, and is it changing?

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  • Biological control company Oxitec recently launched Sparks, a new platform designed to rapidly scale Wolbachia replacement technology to take on dengue fever.

    Backed by a multi-million-dollar investment from the Gates Foundation, Sparks adds to Oxitec’s Aedes aegypti technology, called Friendly, which is taking on dengue fever in Brazil.

    With mosquito-borne diseases on the rise, Oxitec’s Friendly mosquitoes are designed to suppress populations of disease-spreading mosquitoes and, in turn, reduce biting and the threat of disease transmission. Wolbachia-carrying mosquitoes are designed to spread Wolbachia bacteria into the local mosquito population to limit the ability of the remaining infected mosquito population to transmit dengue.

    The platforms are designed for specific settings and intervention types, and provide options for governments and communities seeking suppression, replacement or hybrid approaches using both.

    Our guest on the podcast this week is the CEO of Oxitec, Grey Frandsen.

    00:56-02:12: About Oxitec
    02:12-05:54: The state of mosquito-borne diseases
    05:54-07:09: The effect of climate change
    07:09-08:29: Moving into more developed countries
    08:29-10:27: Wolbachia replacement technology
    10:27-12:53: The Sparks program
    12:53-13:46: Other companies’ approaches
    13:46-15:00: World Mosquito Program
    15:00-15:30: Establishing timelines
    15:30-17:20: The effect on the environment
    17:20-18:54: Could adaptation render the technology useless?
    18:54-20:52: Are the Sparks and Friendly programs being used together?
    20:52-21:57: Do the technologies work differently on different species?
    21:57-26:28: How to determine rollout conditions
    26:28-27:19: Are repeat interventions needed?
    27:19-30:32: Are there limitations based on cost or politics?
    30:32-33:11: Are the technologies applicable to other problems?
    33:11-35:08: Is there anything else in Oxitec’s pipeline?

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  • Immunology is a key area in biotech and biopharma, both in terms of R&D and sales.

    However, according to UK-headquartered Greywolf Therapeutics, the industry has only focused on two-thirds of the puzzle.

    To have an immunological effect, you must activate the body’s T cells, which cells requires a chain of three key signals. The first is antigen recognition, i.e. the initial detection of a cell by a T-cell. The second is the co-stimulation of non-antigen presenting molecules, which enhances the immune response​. The final step is cytokine-mediated differentiation and expansion, which guides how T-cells target threats. ​

    Companies have focused on the second two signals, with signal 2 most commonly seen in therapies such as checkpoint inhibitors and monoclonal antibodies. Signal 3, on the other hand, can be primarily seen in therapies for autoimmune disorders, such as anti-TNF and JAK inhibitors.

    Greywolf Therapeutics is the first company to explore changing signal 1. The company says focusing on signal 1 applies in three key therapeutic areas: oncology, autoimmunity and virology.

    Greywolf’s first candidate has delivered strong results during its ongoing phase I/II trial in oncology, therefore demonstrating proof-of-mechanism and target engagement, with its next candidate well-progressed in preclinical development in autoimmunity.

    To tell us more about the company and its work is Pete Joyce, CEO and co-founder of Greywolf Therapeutics.

    01:19-04:12: About Greywolf Therapeutics
    04:12-04:51: The origins of the name
    04:51-06:52: The three ‘signals’ of the mechanics of immunological responses
    06:52-08:31: Treatments associated with each signal
    08:31-10:09: Why is step 1 important, and why has it not been investigated for treatments?
    10:09-11:28: What areas of disease is this applicable to?
    11:28-12:19: How do you inhibit ERAP?
    12:19-14:01: Greywolf Therapeutics’ candidates
    14:01-15:11: How is this an advance on current treatments?
    15:11-16:05: What is success for patients?
    16:05-17:20: How does the stage of disease affect treatment?
    17:20-18:09: Are other companies looking into antigen modulation?
    18:09-19:47: Has this led to investment opportunities?
    19:47-21:15: Next steps
    21:15-21:55: Do you anticipate more interest in this space?
    21:55-23:21: Attending events

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  • The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit medical research organization dedicated to the development and effective use of products like drugs, vaccines and monoclonal antibodies to address substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, diarrheal diseases, and diseases that impact maternal, newborn, and child health.

    This week, our guest is Dr Claire Wagner, head of corporate strategy and market access at Gates MRI.

    Wagner has dedicated her life to global health. Her early years working in West Africa and East Africa – including five years working with the Rwanda Ministry of Health – were formative experiences for her.

    She helped document health sector outcomes in Rwanda and had a front row seat to the progress the country was making at the time, which led to her pursuing and obtaining an MD and MBA from Harvard.

    Her experiences led to her becoming one of the early employees of the Gates MRI, where she is on the executive leadership team and leads the institute's global access strategy as well as related engagement with commercial partners, financial institutions and multilaterals.

    She tackles the challenge of paving the way for the drugs, biologics and vaccines that the Gates MRI is developing – if they are successful in clinical trials – to be affordable and accessible to the people in low- and middle-income countries who would benefit most. In March 2024 the Gates MRI launched a phase 3 clinical trial for a tuberculosis vaccine candidate, and market access for this candidate is a top priority for Wagner.

    01:51-04:47: Background on Dr Claire Wagner
    04:47-06:24: Work in Rwanda
    06:24-08:40: Gates MRI
    08:40-12:50: Progress at Gates MRI
    12:50-14:06: Gates MRI R&D priorities
    14:06-16:26: The differences between Gates MRI and traditional biotechs
    16:26-18:40: Gates MRI partnerships
    18:40-22:52: The inequality of developing drug treatments
    22:52-25:45: Return on investment
    25:45-27:01: Did COVID increase global awareness?
    27:01-27:44: Other companies working on treatments
    27:44-31:48: Gates MRI pipeline and clinical trials
    31:48-34:51: Working on tuberculosis
    34:51-36:00: Treatment mode of action
    36:00-37:25: Future work at Gates MRI

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  • This week, we are taking a look at an important subject, and that is women working as CEOs, or other senior roles, in the biotech space.

    Kate Yen is the CEO of oncology biotech Auron Therapeutics, and she has spent her entire career in science.

    Auron is working on the next generation of targeted cancer therapies by identifying and inhibiting the oncogenic cell states of cancer. Auron’s AURIGIN platform uses AI and machine learning to compare normal cell states with cancerous cell states to identify novel cancer targets, optimal development models, and biomarkers to guide patient selection.

    Auron is building a pipeline of small molecule targeted therapies, led by AUTX-703, which is being developed for the treatment of solid tumors and hematologic malignancies, including acute myeloid leukemia.

    02:16-07:44: About Kate Yen and Auron Therapeutics
    07:44-09:09: The challenges of setting up a company
    09:09-11:56: Auron Therapeutics’ lead candidate
    11:56-12:52: The rest of the pipeline
    12:52-13:29: Auron timeline
    13:29-15:01: Are there specific challenges being a female biotech CEO?
    15:01-15:49: Is there support for women in biotech beyond the CEO level?
    15:49-16:51: Helping others
    16:51-17:41: Challenges in the boardroom
    17:41-18:40: Diversity in biotech
    19:40-21:03: Changing mindsets
    22:05-22:59: Being a role model
    22:59-24:43: Attracting women from outside hubs
    25:42-27:28: Diversity and education
    27:28-31:31: The importance of AI
    31:31-32:34: The evolution of Auron

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    This week’s podcast is sponsored by Cryoport Systems, the global leader in comprehensive temperature-controlled supply chain solutions, is proud to introduce IntegriCell™ to preserve the future of medicine. IntegriCell™ cryopreservation services provide an integrated, end-to-end solution to ensure the highest quality, consistency, and viability of manufacture-ready, cryopreserved leukopaks for cell therapies. IntegriCell™ enables seamless, efficient, and reliable cryopreservation services combined with end-to-end supply chain solutions to support the treatment of patients worldwide. For more information, visit Cryoport.com.