Beyond Biotech - the podcast from Labiotech

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.

Sitryx Therapeutics is a private UK biopharma company founded in 2018. It is a leader in the field of immunometabolism, an area of immunology that looks to rebalance the immune system to achieve sustained disease remission in autoimmune and inflammatory diseases. 

Sitryx already has big pharma validation following a deal with Eli Lilly in 2020 worth in excess of $1 billion and is focused on advancing its pipeline of potentially first- and best-in-class therapies, which could address a wide range of chronic conditions, including SYX-5219 for atopic dermatitis.

The company has a broad pipeline of small molecules against novel targets in major autoimmune indications with high unmet need.

To talk about immunometabolism, our guest on the podcast this week is CEO of Sitryx Therapeutics, Iain Kilty.

00:52-01:48: About Sitryx
01:48-02:32: What is immunometabolism?
02:32-05:01: Approaches to address autoimmune and inflammatory diseases
05:01-06:46: Drug development
06:46-08:29: What is Sitryx’s approach?
08:29-11:02: Finding diseases to treat
11:02-13:09: About SYX-5219
13:09-16:08: Inflammatory response
16:08-18:40: About SYX-1042 and Eli Lilly
18:40-19:54: Mode of delivery
19:54-20:49: The Sitryx pipeline
20:49-22:08: Research on immune cell function and other companies’ work
22:08-23:53: Increased interest in the field
23:53-25:06: More investment and deals
25:06-26:30: Future treatments of autoimmune and inflammatory diseases
26:30-27:59: The future of immunometabolism
27:59-29:26: Sitryx’s goals

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LinkGevity, founded by two sisters, is developing anti-necrotic technologies, especially for application in kidney disease.

Carina Kern is the CEO of the company, while Serena Kern-Libera is the chief operating officer. After reading an article about how space-travel is especially damaging to the kidneys, they applied for a place on the inaugural NASA Space-H Accelerator program, and how medicine can support human deep-space missions.

LinkGevity was selected for the program, which is in its inaugural year. LinkGevity was selected as its research has uncovered technology with significant potential to minimize the health and performance risks in human spaceflight.

LinkGevity’s anti-necrotics applications cover four major areas: organoid preservation and growth; cryopreservation; organ growth and preservation; and kidney protection.

LinkGevity’s novel proprietary Blueprint Theory of Aging, developed by Kern, offers a multi-disciplinary framework for understanding the development of age-related diseases and deterioration. The theory enables the company’s AI to accurately identify and target key biological pathways involved in aging and deterioration, with necrosis being one of the most critical processes addressed.

To talk about the company’s technology, and its application to space, we had a conversation with Carina Kern and Serena Kern-Libera.

01:48-05:45: About LinkGevity
05:45-06:39: What is the goal for LinkGevity?
06:39-09:07: Is early intervention important?
09:07-11:10: What is the Blueprint Theory of Aging, and how do you identify and target key biological pathways involved in aging and deterioration?
11:10-13:51: Applying the theory
13:51-15:03: Necrosis and LinkGevity’s Anti-Necrotic technology
15:03-18:37: Blocking necrosis and treating disease
18:37-19:06: Drug delivery
19:06-20:54: The importance of AI
20:54-24:43: Connecting LinkGevity’s work with space
24:43-26:24: The SPACE-H program
27:18-28:13: Other biotech involvement in the program
28:13-30:13:  LinkGevity’s presentation at Space-Comm
30:13-31:00: Keeping space medicine simple
31:00-32:18: The future for LinkGevity
32:18-33:14: LinkGevity’s timescale
33:14-33:47: Clinical trials
33:47-34:53: LinkGevity’s future space work
34:53-35:30: Different space opportunities
35:30-38:12: LinkGevity funding

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Today, gene therapy is at an exciting inflection point as the industry moves beyond the first generation of these therapies. However, challenges and barriers remain in bringing gene therapies to market, particularly as they expand into more prevalent diseases. 

Spur Therapeutics is a clinical-stage biotech company dedicated to developing next generation gene therapies for people living with chronic, debilitating diseases. 

Its lead candidate, FLT201, is an AAV gene therapy for Gaucher disease that is poised to enter phase 3 development in 2025.

This week, we have a conversation with Michael Parini, CEO of Spur Therapeutics, about the future of gene therapy.

01:56-04:01: About Spur Therapeutics
04:01-06:49: Where is the gene therapy field at currently?
06:49-10:44: The biggest challenges for gene therapies, and potential solutions
10:44-13:21: What is the next generation of gene therapy?
13:21-18:08: How can gene therapy be used to take on more diseases? How can it be cheaper?
18:08-19:14: Are other companies working on next-generation gene therapies?
19:14-21:07: What is Gaucher disease?
21:07-22:32: How are you tackling Gaucher disease?
22:32-26:07: What is the measure of success?
26:07-28:18: About adrenomyeloneuropathy
28:18-29:32: Upcoming approvals in gene therapy
29:32-31:40: How quickly is gene therapy evolving?

This podcast is sponsored by Vetter, a globally leading CDMO, with over 70 years of experience as a responsible, independent family business. Driven by more than 6,600 employees worldwide, Vetter provides life-saving injectable drug products to the patients that rely on them most. Vetter partners with its customers throughout the entire product lifecycle, starting in the early phase of drug development with comprehensive expertise and support in clinical manufacturing for in-human trial material. For more information, visit vetter-pharma.com

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Antibody-drug conjugates have been an area of great interest in the oncology space in recent years, with a record rate of FDA approvals and dealmaking activity. However balancing efficacy and off-site toxicity has remained a challenge.

Some biopharma companies are investing in what they hope will be the next-generation approach to ADCs – bispecific ADCs. 

More than a dozen early-stage clinical trials are evaluating whether adding a second targeting functionality can improve the preciseness of ADCs’ tumor-targeting, as well as potentially overcome the challenge of heterogeneity in solid tumor target expression. 

Bispecific ADCs have been a hot area for dealmaking over the past year, including BMS’ $8.4 billion purchase of a bispecific ADC candidate in December, a $690 million deal between Biotheus and Hansoh this spring, and the recently announced $325 million deal between Prague-based SOTIO Biotech and Biocytogen.

SOTIO’s most advanced ADC, SOT102, is now in a phase 1/2 clinical study in the U.S. and Europe. 

To talk about biotechs in Czechia, and bispecific ADCs, our conversation this week is with Radek Špíšek, CEO of SOTIO.

01:22-03:17: About SOTIO
03:17-06:12: Are there many biotech or biopharma companies in Prague?
06:12-08:16: Are there any challenges or opportunities being in Prague?
08:16-13:21: What are bispecific ADCs and how do they differ from regular ADCs?
13:21-15:37: Are there any challenges using bispecific ADCs?
15:37-17:07: What are the benefits of bispecific ADCs?
17:07-18:40: Do bispecific ADCs address the challenge of balancing efficacy and off-site toxicity?
18:40-19:42: Why are bispecific ADCs such a hot topic?
19:42-21:35: Deals involving bispecific ADCs, and SOTIO’s partnership with Biocytogen
21:35-24:15: What is SOT102?
24:15-26:41: What else is in SOTIO’s pipeline?
26:41-27:47: What is the future for bispecific ADCs?
27:47-29:01: What does this mean for patients?

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Telomeres are structures made from DNA sequences and proteins, and they are found at the ends of chromosomes.

In effect, they cap and protect the end of a chromosome. Telomerase is an enzyme that adds DNA to the ends of chromosomes, and it is reactivated in most cancers. Most human tumors not only express telomerase but also have very short telomeres. This makes telomerase a prime target for cancer therapies. 

MAIA Biotechnology is focused on the pioneering approach of telomere targeting through its lead therapeutic strategy, THIO. 

Currently, MAIA is making strides with THIO in a phase 2 clinical trial aimed at combating high-risk non-small cell lung cancer (NSCLC). THIO targets telomerase, thus disrupting cancer cells’ vital structures, leading to their rapid demise. 

To tell us about MAIA’s groundbreaking work, and the relationships between telomeres, telomerase and cancer, is the CEO and chairman of the company, Vlad Vitoc.

01:16-02:13: About MAIA Biotechnology
02:13-06:24: What is the role of telomerase in cancer?
06:24-07:02: Do other factors affect telomeres?
07:02-08:42: How does your therapy, THIO, work?
08:42-09:08: Safety of THIO
09:08-10:54: How is it administered?
10:54-11:04: Are there other companies working on this?
11:04-12;14: What else is in the MAIA pipeline?
12:14-17:18: MAIA clinical trials
17:18-18:19: Could THIO be a preventative treatment?
18:19-19:46: Is there a lot of research on telomeres and telomerase?
19:46-21:06: Are there cancers that are not telomerase positive?
21:06-21:41: What is the future for telomere-targeting therapies?
21:41-23:14: Are there any challenges?
23:14-25:40: Is word spreading about your treatments?

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C4 Therapeutics (C4T) is a leader in the targeted protein degradation (TPD) field, with two oncology drug candidates currently in clinical trials and collaborations with pharma companies like Merck, Biogen and Roche. 

The clinical-stage biopharmaceutical company is dedicated to creating a new generation of medicines using its TORPEDO platform to design and optimize small-molecule medicines to address difficult-to-treat diseases. 

TORPEDO can design molecular glues and heterobifunctional degraders, giving C4T the capability of targeting almost any disease-causing protein. 

C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes.

C4T is led by CEO and president Andrew Hirsch, who is this week’s guest on the podcast.

01:17-03:01: About C4 Therapeutics
03:01-05:07: What is targeted protein degradation?
05:07-06:21: What kind of diseases can TPD be used to address? 
06:21-10:53: What are the different TPD strategies: PROTAC, molecular glue, lysosome-targeting chimaera (LYTAC), and antibody-based PROTAC?
10:53-12:43: How are those strategies applied?
12:43-13:59: How is TPD improving on current treatments?
15:39-18:24: What is your discovery program, TORPEDO, and how does it work?
18:24-25:19: About C4T clinical trials
25:19-26:13: Reaction to the ESMO presentation
26:13-28:50: Partnerships with pharma companies
28:50-31:26: Are there any hurdles or challenges in using TPD?
31:26-33:23: The future of TPD

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Estonia is working on becoming the first country to implement personalized health at scale through the Estonian National Biobank.

The biobank uses genetic data to create a picture of the Estonian population, leading to the potential adaptation of public health systems. 

The Estonian Biobank has samples from 20% of the adult population; in comparison, UK biobanks only represent 0.7% of the population. With so much data, Estonia can determine risk factors for cancer, cardiovascular disease, mental and reproductive health, informing health investments to improves patient outcomes.

The project seeks to predict patients’ responses to certain medications based on their genetic makeup. As well as better patient outcomes, this approach could save health systems millions on ineffective prescriptions in the long run. It could also be a blueprint for other national health systems, including the NHS, to personalize healthcare at scale.

Earlier this year, the Estonian Biobank announced the next phase of its European Commission funded project in collaboration with sequencing firm PacBio. 

On the podcast this week, we have Professor Lili Milani, head of the Estonian National Biobank, and Neil Ward, VP of EMEA at PacBio.

01:27-04:06: What is the Estonian National Biobank?
04:06-05:15: Background on PacBio
05:15-06:43: What are the benefits of using genetic data to create a picture of the Estonian population?
06:43-08:24: What data is collected, and how is it used?
08:24-09:54: Protecting individual privacy
09:54-11:24: Is the databank used regularly by Estonian citizens?
11:24-12:35: Can the biobank help address disease earlier?
12:35-16:30: Are there economic savings?
16:30-17:16: How to expand the biobank program
17:16-19:44: How does the biobank help personalize medicine?
19:44-20:26: Are there regional differences?
20:26-21:57: How can Estonia’s system be applied to other countries?
21:57-22:57: Has there been international interest in the biobank?
22:27-22:52: Are pharma companies interested in the biobank?
22:52-24:05: The partnership with PacBio
24:05-26:15: Is AI being used in conjunction with the biobank?
26:15-27:26: Is the biobank project similar to other PacBio work?
27:26-29:00: What is the future for the biobank relationship with PacBio?
29:00-31:30: What is the future for the biobank?

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Inflammation appears to affect almost every part of the human body as we age, including cancer, type-2 diabetes, obesity, and neurodegenerative disorders.

NLRP3 inflammasome-induced inflammation is at the root of nearly all disease pathologies including fibrotic, dermatological, rheumatological diseases as well as neurological disorders such as Alzheimer’s disease.

Halia Therapeutics is a clinical-stage biopharmaceutical company pioneering a novel class of small molecule medications designed to combat inflammation.

Halia Therapeutics’ candidates are the first drugs to target the protein NEK7 to inhibit NLRP3 inflammasome activity to resolve chronic inflammation in multiple diseases.

Its lead candidate, HT-6184 is currently being evaluated in two phase II studies – for the treatment of post-procedure inflammatory pain response and cancer (lower-risk myelodysplastic syndromes (LR-MDS).

The company also recently announced a new collaboration to leverage AI in the clinical development of its new Alzheimer's disease drug, HT-4253, targeting a mediator of neuroinflammation called leucine-rich repeat kinase 2 (LRRK2).

This week, or guest is Dave Bearss, CEO of Halia Therapeutics.

01:09-05:49: About Halia Therapeutics
05:49-08:59: What is the difference between acute inflammation and chronic inflammation?
08:59-12:02: What is NLRP3 inflammasome-induced inflammation?
12:02-15:37: What is NEK7 and how does targeting it help inhibit NLRP3 inflammasome activity?
15:37-18:51: What diseases are related to NLRP3 inflammasome activity?
18:51-22:11: What does reducing NLRP3 activity address in these conditions?
22:11-26:46:  With Alzheimer’s and Parkinson’s is inflammation reduction being investigated by other companies?
26:46-24:14: What is Halia’s lead candidate, HT-6184?
34:14-37:03: What is the balance between normal inflammation and reducing chronic inflammation?
37:03-38:34: Is early intervention the key?
38:34-42:18: Would your treatment be good as a preventative measure?

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