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Invivyd Optimizes Development Efficiency with Election of VYD222 for Near-Term Clinical Advancement to Address Urgent Unmet Need for COVID-19 Monoclonal Antibodies
Company seeks to utilize emerging global COVID-19 regulatory frameworks to accelerate development of VYD222 and its pipeline of other candidates VYD222 mAb
About this update from Invivyd, Inc.
[{"type":"text","content":"Company seeks to utilize emerging global COVID-19 regulatory frameworks to accelerate development of VYD222 and its pipeline of other candidates VYD222 mAb candidate has demonstrated in vitro neutralizing activity against dominant variants of concern, including XBB.1.5 Invivyd maintains guidance for initiating a clinical trial in the first quarter of 2023 WALTHAM, Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announces the election of VYD222 to advance into the clinic as a novel monoclonal antibody (mAb) therapeutic option for COVID-19. The company aims to leverage evolving COVID-19 regulatory paradigms and maximize efficiency to deliver this much-needed product for immunocompromised individuals and other vulnerable populations. As of January 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention or treatment of COVID-19. Monoclonal antibodies are well suited to meet the need of immunocompromised individuals because they provide a prompt onset of protection, have a well-characterized safety profile, and do not rely on the individual’s immune response. “The lack of commercially available mAbs in the U.S. is an unacceptable situation for the estimated 8 million people with impaired immune systems who don’t respond to vaccination and means a return to the isolation many of us experienced early in the pandemic,” stated Pete Schmidt, M.D., M.Sc., Chief Medical Officer of Invivyd. “This urgent need was recently acknowledged by the FDA and EMA at a joint workshop in December where a variety of options such as the use of surrogate endpoints and immunologic bridging studies were discussed.” VYD222 is one of the mAb components of NVD200, a combination product that Invivyd previously selected for clinical advancement prior to evolution in the current global COVID-19 regulatory paradigm. The company is prioritizing the clinical development of VYD222 instead of NVD200 with the aim of providing patients with a mAb as quickly and efficiently as possible. 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...