Invivyd在研单克隆抗体VYD222获批新药研究申请，可中和当前新冠流行株

On April 26, Invivyd announced that the U.S. Food and Drug Administration (FDA) had approved the Investigational New Drug (IND) application for its monoclonal antibody (mAb) drug candidate VYD222. VYD222 is being developed to provide immunoprophylaxis against COVID-19 to susceptible populations, such as immunocompromised groups. VYD222 is currently being evaluated in a Phase I healthy volunteer clinical trial in Australia.

Novel coronavirus disease (Corona Virus Disease 2019, COVID-19), referred to as "new coronavirus pneumonia", was named "2019 coronavirus disease" by the World Health Organization. Singapore's "Lianhe Zaobao" website reported on September 24, 2022 that World Health Organization Director-General Tedros Adhanom Ghebreyesus pointed out that there is still a long way to go before declaring the end of the COVID-19 epidemic. According to the existing case data, the main symptoms of novel coronavirus pneumonia are fever, dry cough, and fatigue. Severe cases often develop dyspnea after 1 week, and severe cases rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, coagulopathy, and multiple organ failure.

VYD222 is a novel monoclonal antibody drug candidate under development to prevent COVID-19 in susceptible populations. According to statistics, there are millions of immunocompromised people worldwide, with an estimated 8 million people in the United States alone. These people may not respond adequately to COVID-19 vaccination, increasing their risk of severe consequences of COVID-19. As of April 2023, there are no monoclonal antibodies authorized or approved in the United States for the prevention of COVID-19.

Data have demonstrated that VYD222 has in vitro neutralizing activity against relevant virus variants currently in circulation, including XBB.1.5. The design of VYD222 is based on Invivyd's investigational monoclonal antibody adintrevimab to support the accelerated development of VYD222. The antibody has good safety data and demonstrated clinically meaningful results in a global Phase III clinical trial for the prevention and treatment of COVID-19.

In March 2023, Invivyd announced the selection of VYD222 for clinical development, and subsequently announced the administration of VYD222 to the first batch of participants in the Phase I clinical trial. The ongoing Phase I study is a randomized, double-blind, placebo-controlled, dose-ranging trial (NCT05791318) designed to evaluate the safety, pharmacokinetics, tolerability and serum virus-neutralizing activity of VYD222 in healthy adult volunteers. The dose-ranging trial will evaluate three different doses, each administered as a single intravenous bolus, to assess the drug's effectiveness against the evolution of the virus.

Dave, CEO of Invivyd Hering commented: "We are pleased that the FDA has approved our application for VYD222. We are excited about the progress in the ongoing Phase I clinical trial of VYD222. We have completed the dosing of the first group of patients and have entered the dosing stage of the second group of patients in the Phase I clinical trial. Preliminary results will be available in the second quarter. The rapid progress of our Phase I clinical trial of VYD222 and the recent FDA approval of VYD222 are important steps in our plan to rapidly advance our mAb candidates designed to keep pace with the evolution of the SARS-CoV-2 virus."

Pete Schmidt, chief medical officer at Invivyd, commented: "For the millions of immunocompromised people around the world who may not receive adequate protection from SARS-CoV-2 vaccines, there is an urgent need for new treatments that provide rapid, passive immunity that can be derived from directly delivered mAbs. With the previously authorized anti-SARS-CoV-2 mAbs are inactive against current variants of concern, and we look forward to continuing to work with the FDA and global regulatory authorities to advance VYD222 and our platform-based development approach."