Beyond Biotech - the podcast from Labiotech

Cell therapies are at the cutting edge of personalized medicine but as demand for these therapies grows, how will the industry scale manufacturing to meet patient needs?Fabian Gerlinghaus is co-founder and CEO of Cellares. He and his team have developed the Cell Shuttle, an advanced cell manufacturing technology that is already demonstrating the potential to 10x cell yields while halving costs for pharmaceuticals companies and innovators. Is this the future for smart cell manufacturing?0:52     A starting point in aeronautical engineering2:43     First steps into biotech5:25     Co-founding Cellares6:30     The problem that Cellares addresses11:02   Best practice bio manufacturing17:14   Differentiation in automation18:15   What does success look like for Cellares19:38   Smart factories21:58   Inside the Cellares smart factory26:34   Manufacturing CAR-T and stem cell therapies27:54   Mass production vs personalized medicine31:39   Global ambitions and regional regulators35:07   Positioning Cellares in the marketInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 Culley02:15               Lineage Cell Therapeutics and its mission04:56              Spinal cord injuries06:40              Costs beyond the Individual08:15               Current treatment options10:48               The place for stem cell therapies12:57                Lineage in the clinic16:27                The DOSED program18:37                The advantages of DOSED20:29               Timelines for results21:35               Scaling manufacturing24:28               Partnering with pharma on stem cell therapies26:38               Other applications for stem cell therapies28:49               Mainstreaming stem cell therapies30:52               Challenges ahead32:43               The future for Lineage Cell TherapeuticsInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 Dugi02:51    Lessons learned in top pharma05:10    The gap that Vandria seeks to fill06:21    Mitochondrial therapeutics07:45    Mitophagy inducers and how they work14:53    Comparing approaches to treating neurodegenerative diseases17:20    Aging, longevity, and healthy life years25:26    Challenges ahead27:31    Performance enhancement and resilience31:15    Towards the mainstream?34:35    Looking forward for Vandria36:02    Developments to watch out for in mitochondrial therapeuticsInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 Duma02:44    Advances and breakthroughs in neurosurgery05:33    The vision and impetus for Regeneration Biomedical10:45    Regeneration Biomedical’s R&D pipeline14:12    Milestones ahead14:46    Advancing beyond Alzheimer’s Disease15:52    Stems cells from fat cells19:42    Bypassing the blood-brain barrier22:45    Patient recruitment24:13    The treatment process27:10    The state of stem cell research in the US29:29    The challenge of financing innovative research32:15    Global stem cell research landscape33:14    Controversy in stem cell research34:00    Future horizons for Regeneration Biomedical37:23    Partnering with top pharma companies37:48    Advice for researchers and entrepreneursInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter Learn more about the latest research in Alzheimer's disease treatment! 

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 Immunai01:13-01:45: 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 system26:30-27:18: What will we see from AI in drug discovery in the short term?27:18-28:06: What are the next steps for Immunai?Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 treatments04:16-06:02: Anocca’s approach to T-cell biology, cutting-edge biotechnologies and integrated software06:02-07:58: A different approach to other cell and gene therapy companies07:58-09:16: Facing challenges09:16-10:48: Addressing conditions and diseases10:48-11:54: Pancreatic cancer11:54-13:40: What represents success for Anocca?13:40-14:09: What is VIDAR-1?14:09-16:08: Partnerships16:08-18:05: Scaling up and addressing costs18:05-20:07: How is TCR-T therapy evolving?20:07-23:11: The impact of artificial intelligence23:11-25:16: Anocca timeline25:16-25:57: Closing comments  `Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 Therapeutics05:06-08:59: Issues of obesity08:59-13:20: Companies working on obesity treatments13:20-15:34: Does suppressing appetite affect nutrition?15:34-17:49: Introduction of new obesity treatments17:49-21:33: Approaches other than appetite suppression21:33-22:38: RES-010 mode of action22:38-24:04: Administration methods24:04-25:11: Clinical trials25:11-26:38: Resalis’ pipeline26:38-28:08: Next steps for Resalis28:08-28:36: Effect of obesity on other parts of the body28:36-29:06: Final comments `Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 CatalYm03:38-06:59: Solid tumors and also why they are hard to treat06:59-09:04: Current treatments for solid tumors09:04-10:47: What is immunotherapy resistance?10:47-12:23: What is visugromab?12:23-13:32: CatalYm’s clinical development program13:32-15:12: What represents success for patients using visugromab?15:12-17:50: Other treatment options being developed17:50-19:50: CatalYm’s pipeline and the futureThis week’s podcast was sponsored by TCR Solutions.Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 GenomeThis 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 Therapeutics03:47-06:37: 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 field23:41-24:52: Working with Eli Lilly24:52-27:15: A new frontier in medicine?27:15-28:43: Cost effectiveness28:43-30:07: Clinical trials30:07-31:48: Applications to other diseasesInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

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 Therapeutics01:57-03:17: The challenges of treating solid tumors03:17-06:08: 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 treatment13:47-15:33: Clinical trials15:33-16:22: Timelines16:22-18:08: Does the treatment have other potential applications?18:08-19:59: Cost effectiveness19:59-21:59: Is the goal to cure people? 21:59-22:46: Treatment frequency22:46-24:00: The impact of tumor size24:00-25:23: Seekyo Therapeutics’ pipeline 25:23-27:27: Fund-raising27:27-30:33: Reaction to the therapyInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter