Podovirus

• How to navigate regulatory limbo: a Canadian phage therapy CEO's playbook

  "Phages are not drugs. Every time they say, 'Did you go through regulatory?' I say, 'I can do regulatory, but I'm not a drug.' There's 145 components of the regulatory requirements that I don't fit in."When your health innovation doesn't fit existing regulatory boxes, how do you build a business? Steven Theriault, CEO of Cytophage, has spent 9 years learning to navigate Canada's regulatory maze for phage therapy. From being told "we don't know" by government officials to raising $24M and treating patients, Steven shares his hard-won playbook for building in uncharted regulatory territory.In this episode of the Podovirus Podcast, Jessica Sacher and Joe Campbell talk to Steven Theriault about what he's tried, accomplished and learned in the last ~decade building a phage biotech company in Canada:🎯 The pivot strategy: When hospitals won't buy your innovation, find another market (Steven turned to chicken farmers when Clorox contracts blocked hospital sales) 🏛️ Educating regulators: How to teach government officials about your technology when they've never heard of it (Steven went from 10 officials with no idea what a phage was, to regular advisory calls to shape Canada's approach to regulating phage therapy)📋 Creating your own framework: Why Steven argues phages need different GMP guidelines than traditional drugs, and how to advocate for biological variability 💰 Funding the unfundable: How Cytophage raised $24M for technology that doesn't fit traditional pharma investment models🔄 The workaround approach: Building revenue streams (agriculture) to fund your real mission (human health) when direct paths are blocked🌐 International advantage: Why Steven has more regulatory traction in the US than Canada, and how to leverage global progress domesticallyLearn more:Cytophage website: https://cytophage.com/Steven's 2024 TEDx talk on the future of phage therapy: https://www.youtube.com/watch?v=OyfbKOLNlWgThe CBC News story on Cytophage's first patient treatment: Thea's success story: https://www.cbc.ca/news/canada/manitoba/phage-therapy-infection-1.7156333

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• Why can't patients access phage therapy? Does FDA need to change, or do patients just need a voice?

  "This feels just like the early days of the HIV crisis. People are dying, you're not hearing about it. We need a group like ACT UP to bring this to the public. We're not going to get phage therapy until people start demanding we have it." On this episode, we talk to phage therapy patient advocate Chris Shaffer about how he fought for access to phage therapy to save his own life, and how it's led him to advocate on behalf of other patients being told there's "nothing left" for their infections. He draws parallels between phage advocacy and 1980s AIDS activism, while sharing his successful treatment journey to Tbilisi, Georgia for phage therapy. He shares his vision for a patient-centered future where anyone, not just the well-connected or the lucky, can access phage therapy if it could help them. Here's a taste of what we covered:1. 🦠 Chris's battle with a drug-resistant infection that antibiotics couldn't cure, and how after two years of suffering, he was completely cured in just four months with phage therapy2. 🧪 The major obstacles to phage therapy access in the US: lack of awareness among doctors, patient trust issues, and difficulty finding phages that match specific infections3. 🏥 The striking cost difference: Chris's complete phage treatment at Eliava (including doctor visits, tests, and therapy) cost $4,600 vs. $10,000+ for just a single round of IV antibiotics in the US4. 🔬 How the FDA actually considers phages safe enough that they don't require the same safety testing as antibiotics - but this information isn't reaching patients or doctors5. 📢 Why Chris believes we need more vocal advocacy similar to the HIV/AIDS movement in the 1980s-90s to push for greater phage therapy access6. 📱 Practical ideas for improving access through non-profit phage centers, better education for medical students, and targeted communication strategiesLearn more:- Chris Shaffer's book about his phage therapy journey: https://www.amazon.com/FINDING-PHAGE-Partnered-Bacterial-Superinfection/dp/1733418296- Chris’ website: https://phagetherapyusa.com/- Case study on Chris’ case, published in the International Journal of Clinical Virology: https://www.clinvirologyjournal.com/articles/ijcv-aid1059.php- Eliava Phage Therapy Center in Tbilisi, Georgia: https://eliavaphagetherapy.com/ - 2021 FDA-NIAID Workshop on Phage Therapy transcripts mentioned during the conversation: https://www.fda.gov/media/159401/download- Pranav Johri's case study that helped Chris trust phage therapy: https://pubmed.ncbi.nlm.nih.gov/37790805/- An youtube interview we did with Pranav about his story: https://www.youtube.com/watch?v=V-Qso4q52CY- An interview we published in Capsid & Tail on Pranav's story: https://phage.directory/capsid/phage-therapy-access-india#article- The PASTEUR Act, which Chris mentions: a bill in US congress (still has not passed) on changing how antimicrobials can be paid for by the government: https://www.contagionlive.com/view/an-update-on-the-pasteur-act

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  1:12:16
• Finally, phase 2 data! Inside BiomX's successful phage therapy trial with CEO Jonathan Solomon

  "Finally, finally we have Phase 2 data. We put a dent in the theory that phage therapy doesn't work. Maybe it does work. Maybe it's worth taking a risk."Jonathan Solomon joins Jessica Sacher and Joe Campbell on the Podovirus Podcast to discuss BiomX's exciting Phase 2 clinical trial results, where they used bacteriophages to treat diabetic foot osteomyelitis (DFO). With 40% of DFO patients facing amputation, this is an area of massive unmet need. Jonathan shares how their trial was designed (he credits the team at Adaptive Phage Therapeutics, which began the trial prior to its merge with BiomX), and how it achieved what many of us have almost given up on: positive, statistically significant clinical efficacy data for a phage therapy treatment*.Here's a taste of what we covered:1. 🔬 The "Head of the Snake" theory – why many diabetic foot ID docs believe targeting Staph aureus alone works even in polymicrobial infections2. 💉 Their phage delivery approach: combining IV "debulking" with topical phage application to help break down biofilms3. 🏥 How 12 out of 13 phage-treated patients with bone-deep ulcers showed significant tissue rebuilding vs. only 5 of 9 in the placebo group4. 💰 The commercial viability challenge: "If you're not seeing a 30% improvement, no one would pay for an expensive phage therapy"5. 🧪 How personalized medicine meets practicality – the decision to use just one optimized phage per patient6. 🔭 BiomX's dual-program approach with both DFO and cystic fibrosis trials showing promising resultsLearn more!1. BiomX Positive Phase 2 Diabetic Foot Osteomyelitis Results2. The details of BiomX/Adaptive Phage Therapeutics’ DANCE trial3. Recent key opinion leader discussion of Diabetic foot osteomyelitis results4. BiomX Positive Part 2 Phase1b/2a trial of Cystic Fibrosis results5. BiomX (NYSE: PHGE) website*Added contextTimestamp ~22:50: Technophage (a biotech company in Portugal) did run a prior Phase 1/2a trial for diabetic foot infections. While the study showed their TP-102 phage cocktail was well tolerated and safe, and reported improved outcomes, the authors report it was underpowered to determine the superiority of TP-102 over placebo, as it ended before reaching the final target of 18 patients due to slow recruitment. Technophage is currently running a larger version of this study. Of note, there has been one other successful phase 2 phage trial: the Wright et al. ear infection trial published in 2009. This clinical program would have moved to phase 3, but corporate priorities shifted around the time of the ‘08 crash, and it was dropped (check out this interview with trial lead David Harper to learn more). Phage companies have been trying to re-reach this milestone ever since. Finally, it’s been reached.

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  58:21
• Does every scientist need an AI co-scientist? How two professors solved a years-long viral mystery

  "I was so biased. I knew too much and that's why we couldn't see the obvious answer that was right in front of us for years."In this episode of the Podovirus Podcast, we explore the intersection of AI and phage biology with Professors José Penadés and Tiago Costa from Imperial College London. They share their recent discovery about phage-inducible chromosomal islands (PICIs) and how Google's new (not-yet-released) AI co-scientist tool independently reached the same conclusions they had spent years working toward—revealing how tailless phage capsids can bind with different phage tails to expand their host range.Here's a taste of what we discussed:1. 🧬 First, the biology: José and Tiago discovered that sometimes the end product of a viral lifecycle isn't infectious (yet). It might instead float around as a half-virus (a 'tail-less capsid'), and even mix and match with halves (tails) of other viruses floating around, enabling it to get into a vast array of totally different cells with one simple genetic code. This is the story of PICIs (phage-inducible chromosomal islands). 2. 🤖 How Google's AI co-scientist tool—without access to their unpublished data on this project—accurately proposed the hypotheses and experiments it took them years to come up with (because they seemed to go against dogma in the field)3. 🔬 Why 'knowing too much' can be an obstacle to discovery in science, the beauty of an unbiased companion, piecing apart what they would have done differently if they'd had AI all along, and how José and Tiago will be using AI tools going forwardChapters00:00 Introduction: AI + phage research, and why we wanted to talk to José and Tiago!02:10 First, the biology background: exploring PICIs (phage-inducible chromosomal islands) and their significance10:13 The role of AI in hypothesis generation19:08 Interpreting data and overcoming bias28:40 Future implications of AI in phage therapy37:25 Experimental evidence and hypotheses validation40:46 AI tools and their effectiveness44:38 Interpreting AI outputs and experimental design51:30 The role of AI in scientific discovery57:30 Future of AI in research and collaborationPapers discussed:1. José and Tiago's new preprint on the science of PICIs: https://www.biorxiv.org/content/10.1101/2025.02.11.637232v1.full2. Their companion preprint on exactly how they worked with the AI co-scientist (+ benchmarking against other AI tools!): https://www.biorxiv.org/content/10.1101/2025.02.19.639094v1 More info about Google's AI co-scientist: https://research.google/blog/accelerating-scientific-breakthroughs-with-an-ai-co-scientist/More info about their research: José's lab: https://profiles.imperial.ac.uk/j.penades/aboutTiago's lab: https://profiles.imperial.ac.uk/t.costaWant to learn more about phage satellites? Check out this new Nature Reviews Microbiology by José's team: https://www.nature.com/articles/s41579-025-01156-z

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  1:09:17
• What's the business case for phage therapy?

  “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 policiesChapters:00:00 Introduction to Phiogen and business challenges in phage therapy08:10 Phiogen's technology platform and differentiation strategy15:13 Navigating investor skepticism in antimicrobials27:29 Reimbursement strategies and pricing models35:04 Learning from Live Biologic Product approvals43:59 The Pasteur Act and subscription models47:27 Five and fifteen year outlook for phage therapyKey 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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