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biocqr

02/06/21 7:00 PM

#23511 RE: DewDiligence #23508

Dew, with your keen interest in vaccine companies I'm curious if you looked at Vaxcyte (PCVX), a recent IPO whose CEO is Grant Pickering, the COO is Jim Wassil the former head of Pfizer Vaccines and the Chairman is Moncef Slaoui the former Chairman of Vaccines at GlaxoSmithKline.

Vaxcyte is a spin-off from Sutro Biopharma and has licensed Sutro's Cell-Free Protein Synthesis platform to screen and produce carrier proteins for their vaccines. They claim their carrier protein is superior to proteins produced by random lysine conjugation because CFPS enables site-specific conjugation using less protein without sacrificing immunogenicity.

They have a 24-valent PCV (VAX-24) in the works with an IND filing expected in 2H-2021 and Phase 2 POC readout in 2022. They also have vaccine programs for Group A Strep and Periodontitis.

They look like they could be a player but obviously years away. Any thoughts?




DewDiligence

06/09/21 11:45 AM

#24152 RE: DewDiligence #23508

FDA approves PFE’s Prevnar-20 pneumococcal_vaccine_for_adults:

https://finance.yahoo.com/news/u-fda-approves-prevnar-20-231200834.html

Prevnar-20 is PFE’s enhancement to Prevnar-13 — with protection for 7 additional serotypes that account for about 40% of serious pneumococcal infections. Prevnar-13 has been PFE’s biggest-selling product,* doing $5.9B in 2020 sales. The Prevnar-20 pediatric program has its own set of clinical trials, with an expected BLA submission in 2022.

Meanwhile, MRK is trying to compete in the adult and pediatric pneumococcal-vaccine markets with V114, a 15-serotype. V114 for adults is under FDA review with a PDUFA date in Jul 2021. MRK expects a BLA submission for the pediatric market in late 2021.

Prevnar-20 would seem to have an insurmountable edge versus V114 due to coverage of 5 additional serotypes; however, the commercial success of both vaccines will depend greatly on the recommendations of the CDC’s ACIP committee. ACIP is scheduled to convene in Oct 2021 to make recommendations vis-à-vis the adult market.

PFE recently started a trial to co-administer (but not co-formulate) Prevnar-20 and PFE’s COVID-19 vaccine (#msg-163985031). Although Prevnar has no efficacy against COVID per se, it protects against secondary bacterial pneumonia infections that are the proximal cause of many COVID-related deaths.

*Eliquis is a bigger-selling drug, but Eliquis revenues are split between PFE and BMY.