Ep. 383 - Moderna, Genentech obesity deal, Trump's FDA pick
BioCentury discusses Moderna's major Phase 3 win with Merck in personalized neoantigen vaccines for melanoma, Genentech-Roche's obesity deal with Korean company Hanmi for a urocortin-2 analog, and concerns about FDA independence following the nomination of Trump loyalist Heidi Overton as FDA commissioner.
Summary
The BioCentury This Week podcast episode covers three major developments in biopharma. First, Moderna achieved a significant Phase 3 victory with Merck for a personalized neoantigen vaccine used as an adjuvant with Keytruda in melanoma patients, preventing or delaying recurrence. The stock surged 177% on the first day, adding over $40 billion in market cap, though it gave back about 20% the next day. Analysts note this opens doors to new treatment paradigms beyond infectious disease but highlight numerous unanswered questions: whether the resource-intensive personalized approach will be cost-effective and reimbursable, how it will translate to non-checkpoint inhibitor treatable tumors and other solid tumors, and whether full safety and efficacy data will justify the manufacturing burden. Moderna did not conduct a capital raise despite the stock bump, though executives discussed the Rathman rule about always raising when possible. Second, Genentech and Roche announced a deal with South Korean company Hanmi for a urocortin-2 analog obesity treatment. The deal includes $190 million upfront with potential milestone payments reaching $2.3 billion plus royalties. This product, which just entered the clinic, targets a key unmet need in obesity treatment: reducing fat while preserving lean muscle mass, potentially complementing GLP-1 therapies. This continues Roche's obesity pipeline expansion following their $2.7 billion acquisition of Carmot in 2023. Third, the podcast addresses FDA independence concerns following Heidi Overton's nomination as FDA commissioner. Overton, a Trump loyalist mentored by Scott Gottlieb-era appointee Marty Makary, is expected to advance the MAHA agenda and RFK Jr.'s HHS priorities. Concerns include her vaccine skepticism, abortion opposition, and potential for chaotic regulatory direction, contrasting with Kyle Diamantis's efforts to restore conventional FDA approaches and mend ties with patient advocates. Her confirmation before the Senate HELP Committee, chaired by Senator Cassidy, remains uncertain.
About this episode
A Phase III win for a melanoma vaccine from Moderna and Merck & Co. has opened the door to personalized neoantigen vaccines. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the vaccine’s prospects and the broader implications. The analysts also discuss Roche/Genentech’s deal with Hanmi, which will add to the MNC’s obesity pipeline an asset that the pharma believes could be first in class, and the White House's pick of a Trump loyalist to lead FDA – a move that ha...
Key Insights
- Moderna's Phase 3 melanoma vaccine success opened a new treatment modality, but the market valuation is heavily dependent on unproven applications to non-checkpoint inhibitor tumors and non-immunogenic solid tumors, which represents a significant speculation factor.
- Personalized neoantigen vaccines require tumor tissue and intensive resources to manufacture, creating potential limitations on adoptability across indications and raising questions about whether payers will routinely reimburse them as adjuvant therapies on top of existing treatments.
- Roche's strategic obesity pipeline diversification through the Hanmi urocortin-2 deal targets a specific gap in GLP-1 therapy—preserving lean muscle mass while reducing fat—positioning it as a potential first-in-class complement rather than replacement to existing obesity treatments.
- Heidi Overton's FDA nomination raises concerns about regulatory chaos and ideological influence, as her mentorship under Marty Makary was previously marked by conflicting regulatory signals that frustrated companies, contrasting with recent efforts to restore FDA's conventional independence.
- South Korea is emerging as a significant biotech innovation hub with companies like Hanmi punching above their weight through active deal-making with Western pharmaceuticals, indicating a shift in the geographic distribution of biopharma innovation beyond traditional China focus.
Topics
Transcript
A phase three win for Moderna and Merck has opened the door to personalized neoantigen vaccines. We'll discuss on the BioCentury This Week podcast. We'll also dig into an obesity deal for Genentech and Roche in South Korea, and the White House's pick of a Trump loyalist to lead FDA. It's revived questions of the agency's independence. I'm Jeff Kramer, executive editor here at BioCentury and your host on the BioCentury podcast. And today I'm joined by Lauren Martz, executive director of Biopharma Intelligence, Paul Bonanos, our News Editor and Director of Biopharma Intelligence, and Tierney Baum, Biotech Analyst. Well, first, I mean, we have been very, very busy here at BioSentry working on our annual back-to-school issue. It's out…
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