Episodes
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“Getting our foot through the door to any VC... As soon as they hear we're infectious disease, their eyes kind of get big. And then they hear we're antibacterial, their eyes get bigger. And then they hear we're not small molecule, it's like all the alarm bells are ringing.”
In this episode, we sit down with Amanda Burkardt (CEO) and Mayukh Das (COO) of Phiogen Pharmaceuticals, a new entrant in the phage therapy space, to tackle one of the field's most pressing questions: can phage therapy succeed as a business where antibiotics have struggled? Drawing from their experience building a phage company from scratch, and recent discussions with Medicare, they share how they're thinking about drug pricing, reimbursement strategies, and how they’re navigating investor skepticism in antimicrobial development.
Takeaways:
- Starting with clear differentiation is crucial - Phiogen's directed evolution platform allows them to enhance desired phage properties
- The antibiotics market's poor track record has created significant barriers for phage therapy companies seeking investment
- Unforeseen post-approval monitoring costs contributed to Achaogen’s bankruptcy, and must be factored into business planning
- Recent approvals of Live Biologic Products (LBPs) for recurrent C. diff provide a potential pathway for phage therapy pricing (~$10,000 per treatment)
- CMS (Medicare/Medicaid) engagement early in development is critical for establishing reimbursement strategies — they are happy to talk to startups!
- The UK's subscription model for antimicrobials could provide significant value (~$100M over 3 years) for qualifying companies
- Phage companies must demonstrate value beyond one-time treatment to justify higher price points
- Infrastructure development, like standardized susceptibility testing, remains a critical need
- The field needs both fixed cocktails for mainstream use and flexibility for personalized approaches
- Success requires alignment between unmet medical need, pricing strategy, and reimbursement policies
Chapters:
00:00 Introduction to Phiogen and business challenges in phage therapy
08:10 Phiogen's technology platform and differentiation strategy
15:13 Navigating investor skepticism in antimicrobials
27:29 Reimbursement strategies and pricing models
35:04 Learning from Live Biologic Product approvals
43:59 The Pasteur Act and subscription models
47:27 Five and fifteen year outlook for phage therapy
Key Quotes:
“Getting our foot through the door to any VC... As soon as they hear we're infectious disease, their eyes kind of get big. And then they hear we're antibacterial, their eyes get bigger. And then they hear we're not small molecule, it's like all the alarm bells are ringing.”
"As long as people are dying and there are unmet medical needs, it is doable. Getting the business model to support that is going to be more challenging, but it is a real problem. There are people dying and there are people suffering. And so as long as that will be the case, there is a need.”
"By utilizing some high throughput methods, we could actually train phages in a way that hadn't been done before. And we're able to utilize this machine to enhance whatever antibacterial capabilities we want.”
Learn more:
- John Rex’s financial post-mortem on antibiotic company Achaogen: https://amr.solutions/2024/10/14/plazomicin-achaogen-financial-post-mortem-passpasteur/
- UK subscription model for antimicrobials: https://www.england.nhs.uk/publication/antimicrobial-products-subscription-model-guidance-on-commercial-arrangements/
- Pasteur Act information: https://www.congress.gov/bill/118th-congress/senate-bill/1355
- A blog post Amanda wrote last year for Capsid & Tail on Phiogen's approach to phage therapy: https://phage.directory/capsid/phiogen-missing-middle-ground#article: "The Missing Middle Ground of Phage Therapy: Effective Phage Therapeutics that Bridge Economy, Regulation, and Unprecedented Functionality"
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"Somebody's father, friend, husband just passed away in the most developed country in the world... from a simple infection that probably could have been treated in Georgia."
In this episode, we sit down with Dr. Alexander (Sandro) Sulakvelidze to explore his journey in growing a phage therapy company from scratch, from food to human therapy. Growing up in the Republic of Georgia, phage therapy was a normal thing for Sandro; when he came to the US and saw people dying of preventable infections, he founded Intralytix. This was 26 years ago.
Takeaways:
- Starting with food safety applications proved crucial for Intralytix's survival and success as one of the few profitable phage companies
- The field has transformed from complete skepticism to active engagement, with hundreds attending phage conferences and multiple clinical trials underway
- Current regulatory concerns about transducing phages may be disproportionate given natural background levels in the human gut
- Personalized, customized phage cocktails consistently show better results than "mainstream" fixed cocktails
- Modern healthcare lacks the infrastructure for phage therapy - there's no equivalent to antibiotic susceptibility testing
- AI and machine learning are revolutionizing phage manufacturing, Intralytix is seeing 100% success in predicting optimal production conditions
- The next 5 years may see limited adoption through personalized medicine and nutraceuticals, while mainstream adoption could take 15+ years
- Phage therapy's future may extend beyond infectious disease to microbiome modulation for conditions like obesity and neurological disorders
- Proof of efficacy in rigorous clinical trials remains the critical barrier to widespread adoption and insurance coverage
- The field needs both mainstream products and the flexibility to customize treatments for individual patients
Chapters:
00:00 Introduction to Phage Therapy and Background
06:01 Evolution of Phage Therapy and Regulatory Changes
11:51 Skepticism and Acceptance of Phage Therapy in the West
20:11 Challenges in FDA Approval and Transduction Concerns
26:09 Personalized Medicine and Future of Phage Therapy
35:36 Navigating Regulatory Challenges in Phage Therapy
38:31 Research Gaps and Future Directions
41:45 Infrastructure and Logistical Hurdles
44:31 The Need for Standardization in Phage Testing
46:15 Cross-Pollination Between Food Safety and Human Health
50:38 Future Outlook: Phage Therapy in 5 to 15 Years
57:07 Challenges Ahead: Efficacy and Regulatory Concerns
Key Quotes:
"Deep in my heart, there is no doubt this works. There's just too many successful stories."
"My experience with FDA has been very good... The people we've dealt with have been reasonable."
"The variables you have to examine are mind boggling... We use artificial intelligence to learn what creates the best conditions to grow each phage."
"We are one of the very few phage companies today that actually has sales revenues... If you ignore the very long time, we're probably the only phage company that has some profit."
"The customized cocktail always worked better... scientifically and technically, it has a better chance of working."
Learn more about Intralytix: https://www.intralytix.com/
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Episodes manquant?
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What's it like to be a doctor treating patients with phage therapy in the US today?
Dr. Gina Suh, Mayo Clinic infectious disease physician, tells us:
- How she established phage therapy as an option for her patients at Mayo
- How phages have helped her patients
- What's been hardest
- Where she's hopeful
- Where things have gotten worse
- What's next
This episode, I'm joined by my phage friend Joe Campbell (former NIH program officer)!
This is part 1 of a series we'll be co-hosting together, digging into phage therapy from multiple perspectives, trying to answer our curiosities about what's holding phage therapy back in this country and beyond — stay tuned!
Chapters
00:00 Introduction to our new phage therapy series
01:23 Dr. Gina Suh's journey into phage therapy
06:01 How Gina has shifted how she selects patients for phage therapy
14:35 Challenges Gina has faced with phage therapy
17:46 Research needs: what the field should be studying
26:16 Infrastructure needs: Gina's wishlist
44:34 Gina's phage therapy aspirations
55:18 Why are there no support groups for antibiotic resistance?
Watch this episode on YouTube: https://youtu.be/b2NBYn4jEUo
Learn more:
Paper by Gina and team: Considerations for the use of phage therapy in clinical practice: https://pubmed.ncbi.nlm.nih.gov/35041506/
Video: Gina Suh and John Haverty talk about John's treatment with phages (2021): https://youtu.be/XZPLt6wkh5A?si=PxSZAYmOkn2KICLs
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Welcome to the Podovirus podcast, episode 3! In this episode, I talk with Jesus Fernandez-Rodriguez from Eligo Bioscience, a Paris-based biotech company pioneering microbiome editing using modified bacteriophages.
We talk about Eligo’s recent Nature publication, “In situ targeted base editing of bacteria in the mouse gut”, how it works, and what the team is thinking of doing with it. 💡 Takeaways:- Eligo Biosciences has developed a base editing technology using modified phages to precisely modify populations of E. coli and Klebsiella in the mouse gut microbiome without killing them.- Microbiome hype is not over yet! - Beyond using the editing tool to kill bacteria for therapeutic reasons, this tool can be used to delete a gene or bacterium to probe what happens in vivo, which could help us figure out what to try to drug next - Not all targets need to be infectious disease-based: the gut-brain axis is an interesting area that this approach could be useful for (or any bacteria-causing disease or phenotype)- The Eligo team designed their base editing system using a PICI (phage-inducible chromosomal island) origin of replication, which lets them produce their therapeutic 'cosmid' (plasmid containing lambda phage packaging instructions plus their payload) in an E. coli strain expressing PICI primase, but prevents replication of the cosmid in target bacteria. 📕 Read:Eligo's In Situ Base Editing paper, published July 2024 in Nature: https://www.nature.com/articles/s41586-024-07681-w💻 Check out Eligo Bioscience's website, especially their open roles! https://eligo.bio/Chapters00:00 Introduction to Eligo Biosciences and their work02:22 History and evolution of Eligo Biosciences' technology03:23 Transition from antimicrobial focus to microbiome editing05:21 Base editing, killing bacteria, and modifying bacteria06:11 The importance of understanding and targeting bacterial genes in human disease11:30 Distinguishing base editing from CRISPR and its applications13:27 Different tools for different modifications in bacteria16:16 Engineering phage particles for high transduction efficiencies21:33 Challenges and process of publishing the paper23:29 The value of publishing and attracting talent27:19 Eligo Biosciences' plans for clinical trials and future applications28:43 The importance of bacterial genes in human disease and the new way of thinking29:12 Microbiome Research and Gut-Brain Axis31:34 Challenges in Identifying Microbes and Genes34:48 The PICI System in Eligo's Technology37:14 Multiplexing the Base Editing Approach52:04 Complexity of Identifying Disease-Causing Genes56:25 The Importance of Research and Collaboration
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Welcome to the Podovirus podcast, episode 2! In this episode, Jessica talks with Dr. Joe Campbell, who recently retired as a program officer at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).Joe played a key role in shaping phage research funding and policy during his tenure at NIAID. He reflects on his career, the evolution of phage therapy research, and shares insights into the grant application process.Takeaways- Phage therapy funding at NIAID has evolved over time; it used to be lumped in with antibiotics, but Joe and his colleague Jane Knisely at NIAID eventually spearheaded the creation of phage-specific grants, which had phage people on their study sections! - Phage therapy centers, such as Phage Canada and Phage Australia, play a key role nowadays in providing personalized phage treatments for patients who don't fit the criteria for traditional clinical trials.- Rigorous clinical trials are essential for demonstrating the efficacy of phage therapies and gaining support from governments and healthcare systems.- Phage therapy has the potential to treat a wide range of infections, and Joe is optimistic that clinical trials will show positive resultsChapters00:00 Introduction01:24 Reflections on a Career in the Phage Field06:18 The Evolution of Phage Therapy Funding at NIAID10:53 Taking Action to Support Phage Grants14:09 The Impact of Phage Grants on Research and Funding20:41 The Role of Phage Therapy Centers22:47 Balancing Phage Therapy Centers and Biotech Companies28:25 Challenges in Developing Phage Therapies in the US Healthcare System30:41 The Importance of Rigorous Clinical Trials for Phage Therapies33:38 NIAD's Preclinical Services for Phage Therapy Development34:57 Pseudomonas Mouse Models and In Vitro Assays37:09 The Role of NIAD Program Officers38:46 Addressing the Economic Challenges of Phage Therapy
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This is a very special week. We’re launching the first episode of our Podovirus podcast!
We started this on a whim (I wanted to explore this format, since I love talking to phage people and I love podcasts; and Jan came up with a punny name we couldn't pass up).
Ok, episode 1! I'll be honest — I stayed in science because of how much I love conferences. My phage phriendships are some of my favourites in life, and annual conferences have always pushed my science forward more than anything else.
It was so much fun to chat with Dr. Jeremy Barr, Associate Professor at Monash University, about the Viruses of Microbes (VoM) conference he's co-organizing in Cairns, Australia this July.
We talk about what organizing has been like (take note, whoever applies to host the next VoM in 2026!), what Australia is like (fewer crocodiles than you might think, equally as many koalas), why VoM 2024 will be extra-special for early career researchers, and how to convince your PI to help you get there!
