Invivyd Begins Phase 1 Trial of VYD2311 Monoclonal Antibody for COVID-19

Invivyd, Inc., a biopharmaceutical company, has commenced the first phase of clinical trials for VYD2311, a new monoclonal antibody (mAb) candidate aimed at combating COVID-19. The company announced the initial dosing of participants in a Phase 1 healthy volunteer trial. VYD2311 has exhibited strong in vitro neutralization activity against various post-Omicron COVID-19 variants. This initial trial, which is randomized, blinded, and placebo-controlled, will assess escalating doses, examining safety, tolerability, pharmacokinetics, and immunogenicity in participants.

The Phase 1 trial is taking place in Australia and will explore multiple dosing levels and administration routes, including intramuscular (IM) injections. IM administration is being highlighted for its potential benefits in terms of patient comfort and systemic accessibility compared to intravenous methods. Consistent with Invivyd’s strategic approach, VYD2311 was developed through affinity maturation to be effective against the latest SARS-CoV-2 variants. Preliminary data from this trial are expected by the fourth quarter of 2024, with further clinical results anticipated throughout 2025.

Marc Elia, Chairman of the Board, expressed enthusiasm about VYD2311's potential, emphasizing its capacity to build on the success of PEMGARDA™ (pemivibart). PEMGARDA, which received Emergency Use Authorization (EUA) from the U.S. FDA for COVID-19 pre-exposure prophylaxis in immunocompromised patients, has shown considerable promise. Elia highlighted the persistent global threat posed by COVID-19 and emphasized Invivyd's commitment to developing therapeutics that evolve alongside the virus, aiming to provide better protection than current vaccine boosters.

VYD2311 is specifically designed to address the needs of vulnerable populations, including millions of immunocompromised individuals who may not respond adequately to COVID-19 vaccines, putting them at higher risk for severe disease outcomes. Engineered from adintrevimab, Invivyd's investigational mAb, VYD2311 has a favorable safety profile and has demonstrated significant clinical efficacy in global Phase 3 trials for both prevention and treatment of COVID-19. Its pharmacokinetic properties could allow for more patient-friendly delivery methods, such as intramuscular injections.

On the other hand, PEMGARDA, a half-life extended investigational mAb, was also developed from adintrevimab. It has demonstrated neutralizing activity against major SARS-CoV-2 variants, including JN.1, by targeting the virus's spike protein receptor binding domain (RBD). This inhibits the virus from attaching to the human ACE2 receptor. PEMGARDA, administered intravenously, is authorized under EUA for the pre-exposure prevention of COVID-19 in patients with moderate-to-severe immune compromise. It is not approved for treating COVID-19 or post-exposure prophylaxis. The most common side effects observed, occurring in at least 2% of patients, include infusion-related reactions, infections, and influenza-like symptoms.

To support PEMGARDA’s EUA, Invivyd used an immunobridging approach, leveraging data from other neutralizing human mAbs against SARS-CoV-2. Despite the promising data, there are limitations, including variability in cell-based assay results and the reduced susceptibility of certain SARS-CoV-2 variants to PEMGARDA. The EUA remains valid as long as the national prevalence of resistant variants does not exceed 90%.

Invivyd is focused on creating mAbs to address serious viral infectious diseases, starting with SARS-CoV-2. Their INVYMAB™ platform combines advanced viral surveillance, predictive modeling, and antibody engineering to quickly develop new mAbs that respond to evolving viral threats. In March 2024, the U.S. FDA granted EUA for Invivyd’s first mAb, marking a significant milestone in their ongoing mission.

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