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Re: biocqr post# 23511

Saturday, 02/06/2021 9:32:41 PM

Saturday, February 06, 2021 9:32:41 PM

Post# of 30523
PCVX is intriguing, but see the caveat below. I posted the announcement of PCVX’s IPO in #msg-156235041 and made a mental note to keep track of the VAX-24 program since it could eventually be competition for PFE (and MRK).

The caveat I’m talking about relates to this (from the S-1 filing for the IPO):

https://www.sec.gov/Archives/edgar/data/1649094/000119312520150234/d802328ds1.htm

We believe our PCVs [i.e. VAX-24 and the potential follow-up compound, VAX-XP] could receive regulatory approval based on a demonstration of non-inferiority to the standard of care using well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.

Even if this is true, by the time VAX-24 is ready for phase-3, the “standard of care” for pneumococcal vaccines will be Prevnar-20 and V114—not the older-generation Prevnar-13 and Pneumovax. If VAX-24 merely shows non-inferiority to the older-generation vaccines (which is what the language in the S-1 filing suggests is the company’s aim), I doubt that that will be enough to make VAX-24 a success in the commercial marketplace.

Thanks for bringing this company to the discussion, and feel free to challenge my take on the above.

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