Beyond Biotech - the podcast from Labiotech

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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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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Pentixapharm is a clinical-stage radiopharmaceutical development company targeting a range of diseases. 

While it is currently owned by the Eckert & Ziegler Group, it will soon be spun off as a separate company. Pentixapharm’s clinical pipeline includes PENTIXATHER, am Yttrium-90 based therapeutic against CNS lymphoma, and PENTIXAFOR, a Gallium-68 based companion diagnostic. Additionally, PENTIXAFOR is being developed as a diagnostic tool for primary aldosteronism (PA), a significant cause of hypertension.

Recently, the company announced the acquisition of the target discovery business of Glycotope.

The deal includes a portfolio of preclinical antibodies against multiple oncology targets that can be developed into radiopharmaceuticals. It also includes Glycotope’s laboratories, cell banks, tumor target data base, and the equipment needed to exploit the discovery platform, along with a range of patents, licenses, and other tangible assets. 

This week, we had a conversation with Andreas Eckert, founder and chairman of the supervisory board at Pentixapharm.

00:57-03:07: About the Pentixapharm spinout
03:07-05:19: What is Pentixapharm’s pipeline?
05:19-06:01: What is the CXCR4 ligand approach?
06:01-08:51: What are the development plans for tackling primary aldosteronism? 
08:51-10:28: Is the process fast, and what about cost?
10:28-11:47: The bigger economic picture
11:47-14:12: About Glycotope
14:12-14:44: How synergistic are Pentixapharm and Glycotope?
14:44-15:32: Is the entire company being acquired?
15:32-16:27: Will outsourcing still be important to the company?
16:27-17:55: What does the future hold for Pentixapharm?

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There are many questions when it comes to setting up a biotech company, and raising funds.

Currently, many companies are concerned about fundraising, but there are things that can be done to maximize efforts. Does a company’s location affect fundraising? What is the best approach to successfully raise funds? What are the current trends in biotech funding?

To look at questions surrounding the state of European biotech funding, and how it compares with the global scene, intellectual property, and how to challenge the status quo, we have a conversation with Dima Kuzmin, managing partner at 4BIO Capital.

4BIO is an international venture capital firm unlocking the treatments of the future by investing in advanced therapies and other emerging technologies.

00:45-02:36: About 4BIO
02:36-07:39: What are the trends in biotech investments currently?
07:39-09:30: Is being in a well-known biotech hub necessary to raise funds?
09:30-14:14: Is relocation necessary for companies starting up if they aren’t near a biotech hub?
14:14-17:57: What differences are there in investment patterns between Europe, the US and Asia?
17:57-21:35: How can funding match the research strength there is in Europe?
21:35-25:07: Are there any emerging hubs in Europe, or opportunities to create new hubs?
25:07-26:36: Are Spain and Italy good locations for biotech?
26:36-28:32: What are the best ways for European companies to attract US and Asian capital?
28:32-35:47: How do you see the European biotech space evolving?

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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 August 16, 2024! Have an awesome summer!

Epic Bio is an epigenetic editing company, leveraging the power of CRISPR without cutting DNA.

The company’s proprietary Gene Expression Modulation System (GEMS) includes the smallest Cas protein known to work in human cells, enabling in vivo or ex vivo delivery via a single viral vector. 

This week, we discuss epigenetic editing, why it’s reversible, and how it can treat FSHD and other conditions, with Epic Bio’s founder, Dr Stanley Qi, one of the original inventors of CRISPR.

01:15-02:51: Dr Xi’s background
02:51-05:11: The beginning of Epic Bio
05:12-09:23: What is epigenetic editing?
09:23-10:47: What is the Gene Expression Modulation System?
10:47-12:47: How is the editing reversible?
12:47-18:01: How will epigenetic editing advance treatments?
18:01-21:24: Tackling multiple conditions
21:24-22:46: How will your platform tackle FSHD?
22:46-24:18: FSHD clinical trial
24:18-25:51: How will you address costs?
25:51-27:18: Are other companies working on epigenetics?
27:18-29:27: What else is in the pipeline?
29:27-31:58: What are the next steps?

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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 August 16, 2024! Have an awesome summer!

Artificial intelligence (AI) is certainly in the news constantly; however, it’s been used in drug discovery for some time.

A new collaboration between artificial intelligence drug discovery company Insilico Medicine and University of Toronto biochemist and molecular geneticist Igor Stagljar will test AI-designed molecules against "undruggable" cancer targets. 

The research will test 15 to 20 undruggable targets - but are they undruggable? And how does AI work in the drug discovery process?

This week, we have a conversation with Kyle Tretina, Alliance Manager of AI Platforms at Insilico Medicine, on a wide range of subjects including drug discovery, undruggable targets, the collaboration with the University of Toronto, and more.

00:58-05:11: About Insilico Medicine
05:11-06:09: Why is AI in the news?
06:09-07:39: Helping people through AI
07:39-09:10: What is Insilico Medicine doing with AI?
09:10-10:15: Does Insilico Medicine take drugs from idea to trials?
10:15-11:32: How do your partnerships come about?
11:32-19:34: How does drug development start with AI?
19:34-24:43: Can AI address undruggable targets?
24:43-25:05: What do you need to do after finding a potential drug?
25:05-27:57: Can quantum computing aid drug development?
27:57-30:13: How can AI help reduce costs and save time?
30:13-32:56: What is your partnership with the University of Toronto?
32:56-36:24: What is the timescale for introducing drugs from AI?
36:24-37:29: What conditions are you working on?

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Aurion Biotech is a US biotech with a regenerative medicine platform, developing novel therapies to restore vision to millions of people in need. 

This week on the podcast, we have a conversation with CEO Greg Kunst about Aurion’s pipeline, and how the company’s treatment could be the first mass-market cell therapy available.

The FDA has granted the company BTD and RMAT designations for AURN001 -- the first-ever allogeneic cell therapy candidate in development to restore vision in patients with corneal endothelial disease. This is a condition with around 16 million patients in the US, Japan and Europe alone. The current standard of care is currently transplant surgery.

Aurion's proprietary process can turn cells from one donor cornea into more than treatments, with the potential to scale to more than 1,000, closing the gap on the global shortage of donor corneas.

Aurion recently completed enrollment of a phase 1/2 trial in the US and Canada.

00:43-01:53: About Aurion
01:53-03:12: What are allogeneic cell therapies?
03:12-04:11: Why is the eye a good target for allogeneic cell therapy?
04:11-06:16: What is corneal endothelial disease?
06:16-07:18: Is corneal endothelial disease genetic or just age related?
07:18-09:22: Is transplant surgery the only option?
09:22-10:58: Are other companies working on corneal endothelial disease treatments?
10:58-12:26: How does your treatment work?
12:26-13:36: Does your treatment alleviate the shortage of corneas?
13:36-15:47: How would you get your treatments around the world?
15:47-17:02: Could these treatments extend to other diseases?
17:02-18:36: What do you need for a mass market treatment?
18:36-19:36: Will there always be a need for this treatment?
19:36-21:12: Is your treatment easy to administer? 
21:12-22:41: What do the FDA designations mean for Aurion?
22:41-24:38: Where are you with clinical trials?

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LabGenius is a drug discovery company developing next-generation therapeutic antibodies.  

The company’s discovery platform, EVA, integrates several technologies drawn from the fields of artificial intelligence (AI), robotic automation and synthetic biology. 

LabGenius operates under a hybrid business model that involves partnering with large biotech and pharma companies while pursuing its own wholly-owned therapeutic pipeline.

The company recently closed a £35 million Series B financing round, bringing its total funding to date to £58 million. 

The hype around generative AI and machine learning is driving unprecedented investor interest in AI. But are investors, and other drug discovery biotech companies, knowledgeable about AI and its role in drug discovery? To look at how AI is making a difference in medicine, and where the hype doesn’t meet expectations, we had a conversation with LabGenius founder and CEO, Dr. James Field. 

01:09-02:38: About LabGenius
02:38-05:45: What does your recent funding mean for your AI platform and pipeline?
05:45-08:14: Do the terms AI and ML create and confusion?
08:14-10:06: The positives of AI in drug discovery
10:06-11:07: How to ask the right questions for AI to work
11:07-12:44: Are investors up to speed on the use of AI in medicine?
12:44-14:09: Where can AI help the most in the drug discovery process?
14:09-15:18: Are there any areas where AI is just hype?
15:18-16:37: Are you working towards clinical trials?
16:37-19:16: How do companies plan an AI strategy?
19:16-19:57: How useful are results from AI? 
19:57-21:48: Should companies outsource AI?
21:48-23:02: Do investors need advice on investment in AI companies?
23:02-24:02: How do you see the evolution of AI in drug discovery?
24:02-25:27: And how do you see the evolution of LabGenius?

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