Jesse
Senior Member (Voting Rights)
Key points:
Source: https://investors.adagiotx.com/news...leading-researchers-form-spear-spike-protein/
- SPEAR Study Group initiated following multiple, independent reports of substantial clinical benefit associated with PEMGARDA® (pemivibart) therapy among people with Long COVID
- SPEAR Study Group collaborators Drs. Michael Peluso, Amy Proal, and David Putrino are key thought leaders in the clinical and translational biology of Long COVID and Post-Vaccination Syndrome
- Initial SPEAR clinical efforts to be aimed at rigorous, controlled assessment of monoclonal antibody safety, translational biology, and exploratory efficacy in relevant patient populations characterized by persistent virus or circulating SARS-CoV-2 spike protein
WALTHAM, Mass., July 02, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that it has formed a best-in-class clinical and translational study group, the SPEAR Study Group, with leading investigators focused on the biology and clinical disease or injury associated with chronic exposure to SARS-CoV-2 virus or mRNA vaccine-mediated spike protein. The SPEAR Study Group will structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibody (mAb) therapy in people suffering from Long COVID or Post-Vaccination Syndrome (PVS), conditions believed to be mediated by persistent viral reservoirs or circulating spike protein. Persistent SARS-CoV-2 spike protein has been identified in both populations, and both populations have overlapping manifestations of apparent clinical disease. As many as 5% or more of Americans have reported recent Long COVID symptoms, an extraordinary medical burden that will continue to evolve as infections continue in the U.S.
The SPEAR Study Group was initiated in response to a growing number of case reports and reported case series from across the U.S. suggesting meaningful symptom relief / remission of Long COVID following use of PEMGARDA® (pemivibart), a monoclonal antibody currently authorized by the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised individuals. PEMGARDA is not authorized for the treatment of Long COVID. While these emerging reports are anecdotal and uncontrolled, they collectively support a longstanding, mechanistically plausible hypothesis: that prolonged exposure to pathogenic SARS-CoV-2 spike protein or other forms of persistent virus or viral material may drive disease in some patients, and that reducing this burden through monoclonal antibody therapy may offer a promising therapeutic approach worthy of rigorous clinical investigation. Clinical research to be planned by the SPEAR Study Group is critical to exploring disease biology and evaluating efficacy endpoints that can enable registrational studies if appropriate in the future.
The SPEAR Study Group includes the following investigators and researchers who, along with Invivyd, will collaborate on the design and anticipated execution of relevant clinical trials:
“It is now clear from a growing body of high-quality, peer-reviewed research that persistent spike protein or viral reservoirs can be identified in a meaningful portion of people with Long COVID,” said Dr. Peluso. “For the first time in years, there is a company with the capability to explore this space using active, broadly neutralizing monoclonal antibodies. This research marks an essential step toward understanding what may cause debilitating COVID-driven chronic disease, and we hope will lay the groundwork for future efficacy studies that could deliver real therapeutic options to patients who have waited far too long.”
“Long COVID is a pervasive, debilitating, and underappreciated public health challenge affecting millions of adults and children in the U.S., with no approved treatments,” said Marc Elia, Chairman of the Board at Invivyd. “Monoclonal antibodies have already demonstrated efficacy in preventing acute COVID-19 infections and treating acute COVID-19 infections, including long-term infections, and emerging anecdotal reports suggest pemivibart may have potential in addressing symptoms in some Long COVID patients. We believe that monoclonal antibodies are key to managing the ongoing burden of endemic COVID-19 disease in all forms, and as previously disclosed, we will be meeting with the FDA early in 3Q to discuss rapid approval pathways for COVID-19 mAbs. Meanwhile, our formation of the SPEAR Study Group is a critical step toward potentially unlocking a Long COVID treatment opportunity for patients in need by generating data needed to inform future studies and potential regulatory pathways. We look forward to sharing future milestones as we advance this important initiative.”
The SPEAR Study Group was initiated in response to a growing number of case reports and reported case series from across the U.S. suggesting meaningful symptom relief / remission of Long COVID following use of PEMGARDA® (pemivibart), a monoclonal antibody currently authorized by the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised individuals. PEMGARDA is not authorized for the treatment of Long COVID. While these emerging reports are anecdotal and uncontrolled, they collectively support a longstanding, mechanistically plausible hypothesis: that prolonged exposure to pathogenic SARS-CoV-2 spike protein or other forms of persistent virus or viral material may drive disease in some patients, and that reducing this burden through monoclonal antibody therapy may offer a promising therapeutic approach worthy of rigorous clinical investigation. Clinical research to be planned by the SPEAR Study Group is critical to exploring disease biology and evaluating efficacy endpoints that can enable registrational studies if appropriate in the future.
The SPEAR Study Group includes the following investigators and researchers who, along with Invivyd, will collaborate on the design and anticipated execution of relevant clinical trials:
- Michael Peluso, M.D., MHS, Assistant Professor of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco
- Amy Proal, Ph.D., Co-Founder and CEO, Polybio Research Foundation and Scientific Director, Mount Sinai Cohen Center for Recovery from Complex Chronic Diseases (“CoRE”)
- David Putrino, Ph.D., Nash Family Director of the Mount Sinai Cohen Center for Recovery from Complex Chronic Diseases (“CoRE”) and Professor, Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai.
“It is now clear from a growing body of high-quality, peer-reviewed research that persistent spike protein or viral reservoirs can be identified in a meaningful portion of people with Long COVID,” said Dr. Peluso. “For the first time in years, there is a company with the capability to explore this space using active, broadly neutralizing monoclonal antibodies. This research marks an essential step toward understanding what may cause debilitating COVID-driven chronic disease, and we hope will lay the groundwork for future efficacy studies that could deliver real therapeutic options to patients who have waited far too long.”
“Long COVID is a pervasive, debilitating, and underappreciated public health challenge affecting millions of adults and children in the U.S., with no approved treatments,” said Marc Elia, Chairman of the Board at Invivyd. “Monoclonal antibodies have already demonstrated efficacy in preventing acute COVID-19 infections and treating acute COVID-19 infections, including long-term infections, and emerging anecdotal reports suggest pemivibart may have potential in addressing symptoms in some Long COVID patients. We believe that monoclonal antibodies are key to managing the ongoing burden of endemic COVID-19 disease in all forms, and as previously disclosed, we will be meeting with the FDA early in 3Q to discuss rapid approval pathways for COVID-19 mAbs. Meanwhile, our formation of the SPEAR Study Group is a critical step toward potentially unlocking a Long COVID treatment opportunity for patients in need by generating data needed to inform future studies and potential regulatory pathways. We look forward to sharing future milestones as we advance this important initiative.”
Source: https://investors.adagiotx.com/news...leading-researchers-form-spear-spike-protein/
