Invivyd’s COVID-19 antibody shows promising safety profile in trial

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD) announced Thursday that its COVID-19 monoclonal antibody candidate VYD2311 demonstrated a favorable safety profile in a Phase 1/2 clinical trial, with all reported adverse events classified as mild to moderate.

The randomized, double-blind study evaluated 40 subjects across multiple administration routes (intravenous, intramuscular, and subcutaneous) and dosage levels. According to the company, VYD2311 maintained high serum concentrations for six months following a single dose, with the intramuscular route showing the longest half-life at 76 days.

VYD2311 builds upon Invivyd’s first-generation antibody pemivibart, which previously received emergency use authorization from the FDA for COVID-19 prevention in certain immunocompromised individuals. The company stated that VYD2311 is structurally similar to its predecessors but features molecular modifications designed to increase potency and improve resistance against viral variants.

Dose modeling analysis conducted by the company suggests that intramuscular administration could offer efficacy comparable to high-dose intravenous dosing while potentially simplifying administration. The company believes this could allow for quarterly dosing schedules.

"These data reinforce our confidence in VYD2311’s potential to offer a highly effective, scalable, convenient, and accessible solution for COVID-19 prevention," said Dr. Mark Wingertzahn, SVP Clinical Development at Invivyd, in the press release.

Invivyd has scheduled a Type C meeting with the FDA for early third quarter to discuss next steps for the VYD2311 program and approval pathways for its COVID-19 monoclonal antibodies. The company expects these discussions to include both prevention and treatment indications for various vulnerable populations.

In other recent news, Invivyd Inc. reported its Q1 2025 earnings, revealing a net product revenue of $11.3 million for its COVID-19 prevention product, PEMGARDA. Despite reducing operating expenses by 15%, the company’s earnings per share and revenue fell short of forecasts. Analysts at H.C. Wainwright responded by cutting Invivyd’s stock target to $5.00, though they maintained a Buy rating, citing potential upcoming catalysts. The company is on track to achieve non-GAAP profitability by the end of the first half of 2025, with early signs of a commercial rebound due to its internalized sales force. Additionally, Invivyd’s monoclonal antibody, PEMGARDA, has been incorporated into the National Comprehensive Cancer Network Clinical Practice Guidelines for B-Cell Lymphomas, offering a preventive option for patients at risk of severe COVID-19 outcomes. Invivyd is also advancing its clinical development of VYD2311 and expanding discovery programs targeting measles and respiratory syncytial virus (RSV). These developments indicate a strategic shift towards establishing a broad-based antibody platform for infectious diseases.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.