FDA Gives Emergency Use Nod To Invivyd's Antibody To Prevent COVID-19 Infection In Adults, Adolescents With Weak Immune System

Friday, the FDA granted emergency use authorization to Invivyd Inc’s IVVD Pemgarda (pemivibart), formerly VYD222, a half-life extended monoclonal antibody (mAb) for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents who have moderate-to-severe immune compromise.

“We are proud that roughly one year after initiating the Phase 1 trial of our mAb now known as PEMGARDA, we are expecting to have product available for order imminently, with initial supply already packaged and awaiting final release at our U.S.-based third-party logistics provider,” said Dave Hering, CEO of Invivyd.

The company estimates it had approximately $200.6 million of cash and cash equivalents as of December 31, 2023. In February 2024, the company sold shares worth $40.5 million in gross proceeds under its At-the-Market facility. 

Based on current operating plans and excluding anticipated cash collections from Pemgarda sales, Invivyd expects its existing total cash and cash equivalents to provide a cash runway into Q4 of 2024.

Concurrently, Invivyd announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. 

CANOPY is an ongoing Phase 3 trial of VYD222 (Pemgarda) for the pre-exposure prophylaxis of COVID-19, which enrolled adults ≥18 years of age in two cohorts.

In December, Invivyd released initial results from the ongoing CANOPY Phase 3 trial of VYD222.

The company said that VYD222 produced high serum virus-neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, replicating the titer levels observed in the Phase 1 trial of VYD222 in healthy volunteers. 

Additional cases of COVID-19 have occurred in Cohorts A and B post Day 90.

In Cohort B (without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interaction) – The VYD222 arm saw a 0% (0/322) proportion of participants with RT-PCR-confirmed symptomatic COVID-19, compared to 3% (1/314) in the placebo.

Through day 90, symptomatic COVID-19 events of 0.3% in VTD22 versus 5% (8/159) in placebo.

In Cohort A (moderate-to-severe immune compromise), the proportion of participants with RT-PCR-confirmed symptomatic COVID-19 after a median 35 days follow-up saw VYD222 0% (0/306) versus 1% (3/298) in placebo.

Price Action: IVVD shares are down 13.20% at $3.79 on the last check Monday.

Image: Pete Linforth from Pixabay