Invivyd has received advice from the US Food and Drug Administration (FDA) on a rapid pathway to potential Biologics License Application (BLA) approval for its novel monoclonal antibody (mAb) candidate VYD2311, for the prevention of COVID-19.
The FDA provided advice for pursuit of a traditional BLA pathway for the prevention of COVID-19 caused by SARS-CoV-2 in adults and adolescents weighing at least 40 kg, including immunocompromised people, subject to agreement on safety database size and pending full protocol review. A phase 2/3 randomised, double-blind, placebo-controlled trial with a primary endpoint of RT-PCR-confirmed symptomatic COVID-19 was recommended, with a timepoint for measuring the primary endpoint coinciding with the expected duration of protection. This was anticipated as 12 weeks (three months), and the potential for selection of an additional, longer duration timepoint, which Invivyd anticipates as 24 weeks (six months).
“We believe monoclonal antibodies such as VYD2311 can serve as a powerful alternative to vaccines for COVID-19 prevention, and represent an important potential paradigm shift to move American medicine beyond the real and perceived limitations of COVID-19 vaccines,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “COVID-19 monoclonal antibody medicines work alongside natural human immunity without needing to activate the immune system and, amid declining public trust in vaccines, we want to offer Americans a new, non-vaccine choice.”
FDA advice and background statements to Invivyd cited observations on Invivyd’s phase 3 randomised clinical trial of pemivibart for the prevention of COVID-19 (CANOPY), the antiviral durability of pemivibart and the strong protection demonstrated by pemivibart in CANOPY Cohort B, while recognising that Invivyd antibodies stem from a common molecular lineage. Multiple such Invivyd antibodies have undergone successful randomised, placebo-controlled clinical trials, including efficacy assessment. In agreement with FDA advice, Invivyd plans to study two doses of VYD2311 to assess any differences in resulting levels of protection or differences in safety.
“The FDA’s clear and constructive feedback provides a well-defined path forward for our COVID-19 development programme. We believe the FDA’s feedback underscores the shared urgency to advance innovative solutions for prevention of COVID-19,” said Rachael Gerlach, Vice President, Regulatory Affairs at Invivyd. “Combined with Invivyd’s unique discovery platform, this alignment is a critical step in bringing forward a potentially important, medically attractive and patient-friendly alternative to COVID vaccination.”
“Our completed first-in-human study of VYD2311 demonstrated high SARS-CoV-2 antiviral titers and an attractive safety profile at very high doses, well beyond doses we contemplate going forward with in development. We look forward to opening a US IND and moving as quickly as possible to finalise a pivotal clinical trial design with the FDA,” said Mark Wingertzahn, Senior Vice President, Clinical Development at Invivyd.