We’ve all heard about Baylor College of Medicine’s TAILOR Labs for years (I’m convinced they’re almost single-handedly manufacturing compassionate phage preparations for the entire US right now…).
I still remember Austen Terwilliger, TAILOR’s Cofounder and Director of Operations, sitting across from me at a Phage Futures conference dinner in ~2019 saying ‘we’re going to do personalized phage therapy as a service. In Texas.’
My eyes got big — I assumed he didn’t know you couldn’t do that. He was very polite, but said ‘Well, that’s what we’re going to do’ and seemed confused why I was confused. (In the end, he was right!)
6 years later, TAILOR has treated tons of people with phages, is a mainstay in the phage field, and is depended on by countless patients and their doctors. And now, the group has spun off a company to scale up their strategy to more patients. That company is Phiogen Pharmaceuticals.
I was so excited to sit down with Amanda Burkardt, Phiogen’s CEO, to talk about what they’re doing, how they’re doing it, and most importantly…. in this economy??
Biotech is hard across the board, especially these days, but phage therapy companies have struggled from the added issue that infectious disease drug development isn’t really being done by pharma anymore… I’ve been reading about Achaogen’s bankruptcy (the antibiotic company that made a new FDA approved antibiotic, then went out of business right away anyway). Heartbreaking. How is a phage therapy company supposed to avoid that fate?
So this was why I reached out to Amanda. How does she think about the business case for phage therapy? How is she making the math work for her investors, when so many have decided against this sector? Do we need to price phages differently than antibiotics for it to be attractive enough of an investment? Otherwise, how are we ever going to bring phage therapy to patients? How are we going to treat their multi-drug resistant infections at all?
Luckily Amanda was game for this conversation, and she’d been thinking about it a ton too. And she brought along her COO, Dr. Mayukh Das, who actually worked on the iconic 2016 Patterson case, then on the wine grape phage cocktail developed by Texas A&M and A&P Inphatec, then at Johnson & Johnson as Associate Scientific Director of Phage Microbiology (back when J&J had such a department). So he’s been in the phage field for years, has been on the inside of large pharma, and he also took a bet alongside Amanda that they could make a phage therapy company work.
Joe and I were so excited to have them on the podcast, and they did not disappoint!
Highlights from our conversation:
- First — on how Phiogen differentiates itself. One way is it’s developed a “Directed Evolution Machine” that can enhance specific phage properties like host range, biofilm penetration, and immune stimulation.
- Is there a precedent for pricing antimicrobials higher than we typically see? Yes. Recent approvals of Live Biologic Products for C. difficile infections provide a pathway for phage pricing up to ~$10,000 per treatment. Will this be enough? We shall see, but it’s a start.
- US Centers for Medicare & Medicaid (CMS) wants to engage with phage companies much earlier than anyone realized; they recognize precision antimicrobials is a need, and that reimbursement discussions need to be had, now.
- The UK’s new antimicrobial subscription model can provide guaranteed revenue (~$10M a year for 10 years) for certain antimicrobials. This has reassured investors Amanda talks to, and gives her some real numbers to back up discussions of Phiogen’s future economic viability.
A few snippets from the episode…
On investor skepticism:
Amanda: “We are paying for some of the sins of others that have come before us, but [also, this] has just not been proven. And so there’s a lot of things that we’re fighting against that are yet to be seen.”
On technology differentiation:
Amanda: “We found a phage that was hyperlytic. It killed very quickly. But the host range wasn’t as broad as we wanted it to be. And so we ran it through our [directed evolution] machine. And after four hours, we were able to evolve an offspring phage which had increased its host range by 10 to 15 percent.”
On reimbursement pathways:
Mayukh: “The CMS specifically mentioned that they would prefer to be engaged in the drug development process as early as possible. So in that way, they can actually analyze the need of the specific therapy based on many factors like unmet need, your target population… and come up with some specific reimbursement model.”
What’s next for Phiogen:
Watch for updates on Phiogen’s recurrent UTI clinical trial planned for this year, and their collaboration with the patient advocacy group Live UTI Free to develop patient-centric phage products.
Listen to the full episode on the Podovirus Podcast!
This episode is part of our series exploring phage therapy from multiple angles, especially trying to figure out what’s holding it back. Thanks to Joe Campbell, my co-host, for helping navigate these complex questions!
Please subscribe to Podovirus on Apple Podcasts or Spotify to support/encourage us, and to keep up with future episodes as soon as they drop!
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