Invivyd has touted its follow-up to the FDA-authorized monoclonal antibody Pemgarda as potentially offering better protection against COVID-19 than available vaccines.
Pemgarda received emergency use authorization from the FDA last year for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise. Invivyd’s follow-up candidate, dubbed VYD2311, is 99% structurally identical to its predecessor, but with “subtle but critical molecular changes” designed to make it more potent, the biopharma explained in a June 26 release.
The Massachusetts-based company unveiled phase 1/2 data from a 40-person trial that involved administering VYD2311 either intravenously, intramuscularly or subcutaneously. VYD2311 was well tolerated, with the only adverse events linked to the antibody being expected and mainly related to reactions at the injection site.
The in-vivo half-life of VYD2311 was considered an improvement over Pemgarda, with “substantially greater” serum concentrations of the investigational drug remaining in patients at six months when compared to data from its authorized predecessor, Invivyd said.
“VYD2311’s long half-life could allow meaningful, long-term protection from symptomatic disease, potentially over multiple quarters, which is expected to be more durable than a COVID-19 vaccine, given rapid waning of protective benefit,” Invivyd explained in the release. “High dose IV administration could similarly provide very long-term follow-up viral suppression in a COVID-19 treatment use case.”
The biopharma also conducted a “comprehensive dose modeling analysis” to help generate the data needed to get the FDA on board. By using this method, the company claimed that each of the doses and administration routes tested for VYD2311 “appear to eclipse estimated contemporary rates of COVID-19 vaccine protection” for both immunocompromised and non-immunocompromised individuals.
“These data reinforce our confidence in VYD2311’s potential to offer a highly effective, scalable, convenient, and accessible solution for COVID-19 prevention,” Invivyd’s SVP of Clinical Development, Mark Wingertzahn, Ph.D., said in the release.
“The safety profile, long half-life, and novel dosing strategies explored with VYD2311 not only build upon the well-established science for COVID-19 mAbs to achieve robust modeled efficacy targets but also align with our mission to provide non-vaccine mediated protection to those most at risk, including immunocompromised individuals, in a manner that integrates seamlessly into standard healthcare settings,” Wingertzahn added.
Invivyd will be hoping that the FDA is more amenable to VYD2311 than it was to the company’s attempts to get Pemgarda’s indications expanded back in February—a request that the agency refused. At the time, the biopharma said the FDA required Pemgarda to meet a “standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs.”
When it comes to COVID vaccines themselves, the impact of the FDA’s updated polices remains uncertain, although the agency did give the nod to Moderna’s new candidate earlier this month.