From llamas and camels to humans worldwide. Nanobodies are enjoying success in the clinic and experts are hailing these camelid-derived biologics as one of the next big things in immunotherapy.

Kristian Reich is co-founder and CSO of MoonLake Immunotherapeutics. After a long and distinguished career as a clinician and researcher, Kristian helped to launch MoonLake in 2021 and quickly helped move their lead candidate to the clinic. Now, on the verge of Phase III trials, he joins 'Beyond Biotech' to talk nanobodies, innovation, serendipitous science, and the power that comes from never stopping to dream.

01:04               Meet Kristian Reich

05:26               Excited by the science of nanobodies

07:13               MoonLake’s mission

13:12               Milestones at MoonLake

15:24               Introduction to nanobodies

17:55               Serendipitous science

19:46               How nanobodies work

23:18               Global prevelance of immune conditions

24:31               The impact on patients

27:09               Nanobodies in the clinic

31:19               Manufacturing challenges, regulatory challenges

34:04               Working with top pharma

35:55               The future of nanobodies

37:42               The future of MoonLake

39:10               Don’t stop dreaming

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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 engineering

2:43     First steps into biotech

5:25     Co-founding Cellares

6:30     The problem that Cellares addresses

11:02   Best practice bio manufacturing

17:14   Differentiation in automation

18:15   What does success look like for Cellares

19:38   Smart factories

21:58   Inside the Cellares smart factory

26:34   Manufacturing CAR-T and stem cell therapies

27:54   Mass production vs personalized medicine

31:39   Global ambitions and regional regulators

35:07   Positioning Cellares in the market

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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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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 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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