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Invivyd Announces New England Journal of Medicine Publishes Letter to the Editor Highlighting Immunobridging Pathway Leading to PEMGARDA™ (pemivibart) Emergency Use Authorization; Comments on Adjacent Third-Party Letter to the Editor
The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an
About this update from Invivyd, Inc.
[{"type":"text","content":"The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an updated correlate of protection curve for monoclonal antibody protection from symptomatic COVID-19The updated correlate of protection analysis published in the Letter to the Editor indicates the potential for strong protection from symptomatic COVID-19 at titer levels well below doses explored clinically with pemivibart, consistent with recently disclosed CANOPY exploratory efficacy data, and useful for future drug developmentCompany expresses disappointment in NEJM’s publication of a separate Letter to the Editor from a third-party, academic laboratory reflecting outdated, inaccurate virology data produced with “research-grade” “pemivibart”PEMGARDA™ (pemivibart) Fact Sheet continues to include accurate data reflecting neutralization activity against KP.3.1.1 WALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announces that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor describing the PEMGARDA™ (pemivibart) immunobridging emergency use authorization (EUA) pathway, as well as an updated correlate of protection (CoP) curve for prevention of symptomatic COVID-19 via recombinant monoclonal antibodies (mAbs) such as pemivibart. The immunobridging approach highlighted in NEJM draws on pharmacokinetic bioequivalence principles and was designed by the U.S. Food and Drug Administration (FDA) to allow rapid development and authorization of serial, novel mAbs that can protect vulnerable populations from symptomatic COVID-19 amid a rapidly evolving variant landscape. The immunobridging approach established by the FDA for pemivibart development relied on a comparison between the serum virus neutralizing antibody (sVNA) titers of a novel antibody, pemivibart, and the sVNA titer associated with previous clinical protection at a single point in time from a single prototype mAb, in this case, Invivyd’s prior investigational mAb, adintrevimab. The updated CoP data curve for mAbs also published in the NEJM letter as Figure 1B builds on prior published work1 and provides a meta-analytic continuous curve describing t...