A clinical trial generating safety, pharmacokinetics, and dosing data with the goal of providing information to allow for rapid advancement into a pivotal Phase 3 trial
WALTHAM, MA, USA I March 30, 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 dosing of the first participants in a Phase 1 healthy volunteer trial of VYD222, a novel monoclonal antibody (mAb) candidate for COVID-19.
The Phase 1 randomized, blinded, placebo-controlled, dose-ranging trial will evaluate the safety, pharmacokinetics, and tolerability of VYD222 (NCT05791318). The dose-ranging trial will evaluate three different doses, each administered in an IV infusion. All dose levels are designed to provide durability in the face of viral evolution and flexibility at the time of regulatory submission. This Phase 1 trial is being conducted in Australia.
The company expects preliminary data readouts from the Phase 1 trial in the second quarter and anticipates additional clinical readouts from the VYD222 program throughout the remainder of 2023.
“We are excited to initiate a first in human clinical trial of VYD222,” said Dave Hering, chief executive officer of Invivyd. “With previously authorized mAbs losing activity against currently circulating SARS-CoV-2 variants, there is a global, urgent unmet need for new therapeutic options for vulnerable populations, including individuals who have a reduced immune response to vaccination. By leveraging our expertise in virology, predictive modeling and antibody engineering, VYD222 is the next of multiple candidate mAbs we aim to advance from our pipeline with the goal of keeping pace with viral evolution and protecting the most vulnerable.”
About VYD222
VYD222 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including 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 March 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention or treatment 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
(Nasdaq: IVVD)
Invivyd, Inc., 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
Post Views: 374
A clinical trial generating safety, pharmacokinetics, and dosing data with the goal of providing information to allow for rapid advancement into a pivotal Phase 3 trial
WALTHAM, MA, USA I March 30, 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 dosing of the first participants in a Phase 1 healthy volunteer trial of VYD222, a novel monoclonal antibody (mAb) candidate for COVID-19.
The Phase 1 randomized, blinded, placebo-controlled, dose-ranging trial will evaluate the safety, pharmacokinetics, and tolerability of VYD222 (NCT05791318). The dose-ranging trial will evaluate three different doses, each administered in an IV infusion. All dose levels are designed to provide durability in the face of viral evolution and flexibility at the time of regulatory submission. This Phase 1 trial is being conducted in Australia.
The company expects preliminary data readouts from the Phase 1 trial in the second quarter and anticipates additional clinical readouts from the VYD222 program throughout the remainder of 2023.
“We are excited to initiate a first in human clinical trial of VYD222,” said Dave Hering, chief executive officer of Invivyd. “With previously authorized mAbs losing activity against currently circulating SARS-CoV-2 variants, there is a global, urgent unmet need for new therapeutic options for vulnerable populations, including individuals who have a reduced immune response to vaccination. By leveraging our expertise in virology, predictive modeling and antibody engineering, VYD222 is the next of multiple candidate mAbs we aim to advance from our pipeline with the goal of keeping pace with viral evolution and protecting the most vulnerable.”
About VYD222
VYD222 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including 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 March 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention or treatment 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
(Nasdaq: IVVD)
Invivyd, Inc., 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
Post Views: 374
