• On track for initial readouts in Q2 2023 from ongoing Phase 1 VYD222 clinical trial being conducted in Australia, with cohort 1 dosing complete
  • Discussions are underway with the FDA and global regulators regarding the company’s proposed VYD222 pivotal clinical trial design

WALTHAM, MA, USA I April 25, 2023 I Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for VYD222, a monoclonal antibody (mAb) candidate. Invivyd is developing VYD222 for the prevention of COVID-19 in vulnerable populations, such as immunocompromised people. As previously announced, VYD222 is currently being evaluated in an ongoing Phase 1 healthy volunteer clinical trial being conducted in Australia.

“We are pleased that the FDA has cleared our IND for VYD222 and we are excited by the progress we’ve made in our ongoing Phase 1 VYD222 clinical trial,” said Dave Hering, chief executive officer of Invivyd. “We have completed dosing of the first cohort and have moved to the second dosing cohort, with initial readouts from the Phase 1 clinical trial on track for the second quarter. The swift progress of our Phase 1 VYD222 clinical trial, along with the FDA’s recent clearance of the VYD222 IND, are important steps in our plan to rapidly advance a stream of mAb candidates designed to keep pace with SARS-CoV-2 viral evolution.”

“For the millions of immunocompromised people around the world who may not generate adequate protection from SARS-CoV-2 vaccines, there is an urgent need for new therapeutics that provide the rapid, passive immunity that results from the direct delivery of mAbs,” said Pete Schmidt, M.D., M.Sc., chief medical officer of Invivyd. “With the previously authorized anti-SARS-CoV-2 mAbs losing activity against current variants of concern, we look forward to continuing to work with the FDA and global regulators to advance VYD222 and our platform-based approach to development.”

In March 2023, Invivyd announced the election of VYD222 for clinical development and subsequently announced dosing of the first participants in a Phase 1 VYD222 clinical trial. The ongoing Phase 1 trial is a randomized, blinded, placebo-controlled, dose-ranging trial that will evaluate the safety, pharmacokinetics, tolerability, and serum virus neutralizing activity of VYD222 in healthy adult volunteers (NCT05791318). The dose-ranging trial will evaluate three different doses, each administered as a single IV push. All doses are designed to provide durability in the face of viral evolution and flexibility at the time of regulatory submission.

About VYD222

VYD222 is a novel monoclonal antibody (mAb) candidate in development for the prevention of COVID-19 in vulnerable populations, such as immunocompromised people. Globally, there are millions of immunocompromised people, with an estimated 8 million in the U.S. alone, who may not adequately respond to COVID-19 vaccination, increasing their risk for severe outcomes from COVID-19. As of April 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention of COVID-19.

VYD222 has demonstrated in vitro neutralizing activity against currently circulating variants of concern, including XBB.1.5. VYD222 was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19. The company believes the adintrevimab clinical data have the potential to support accelerated development of VYD222.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. ​​Invivyd’s technology works at the intersection of evolutionary virology, predictive modeling, and antibody engineering, and is designed to identify high-quality, long-lasting antibodies with a high barrier to viral escape. The company is generating a robust pipeline of product candidates which could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications. Visit https://invivyd.com/ to learn more.

SOURCE: Invivyd