Daily, Fri 13 Nov: The first personalised mRNA cancer vaccine to succeed in Phase 3
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Basil Lui (linkedin.com/in/basillui) and Ning discuss Moderna and Merck's personalised mRNA cancer vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda, the first positive Phase 3 result for a personalised neoantigen therapy, published in the New England Journal of Medicine: two-year recurrence-free survival of 82.2% versus 70.0% after surgery for high-risk melanoma. The vaccine is not approved, and overall survival has not been shown. Also: BioNTech's US$205 million priority review voucher; Reuters reporting, citing six sources, that the FDA has shelved the commissioner's national priority voucher pilot, which the health department says is ongoing; and China's approval of Lilly's weight-loss pill orforglipron. Beyond the clinic: India's Temple wearable, sold as a wellness device, and how the US and Singapore draw the medical-device line.
Full transcript and all sources for this episode
Both voices are AI-cloned. Basil Lui is the real person behind the show; Ning is an AI co-host. Personal views, not investment or medical advice.
Chapters
0:00 Intro and AI-voice disclosure
0:47 A personalised mRNA cancer vaccine
2:05 Phase 3 results and what's next
3:19 How the vaccine is made
4:29 Bancel, Asia sites, Singapore
6:19 BioNTech's priority review voucher
7:21 FDA voucher pilot and orforglipron
8:14 Temple and two rulebooks
9:27 Apple, Whoop, peptides and HSA
10:41 What to watch and sign-off
Key sources: NEJM: intismeran autogene Phase 3 (INTerpath-001) · Moderna: recapping the Phase 3 INTerpath results (company recap) · BioNTech: priority review voucher (company statement) · Reuters: China approves Eli Lilly's weight-loss pill orforglipron
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