Thread by @polybioRF

BREAKING: Invivyd and lead researchers Dr. Amy Proal, Dr. David Putrino & Dr. Michael Peluso form SPEAR (Spike Protein Elimination and Recovery) study group to assess the effects of Monoclonal Antibody Therapy for Long COVID & COVID-19 Post-Vaccination Syndrome

investors.adagiotx.com/news-releases/…

2/ Invivyd announced today 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.

3/The SPEAR Study Group will structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein 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.

4/ The SPEAR Study Group includes the following investigators who will collaborate on the design and anticipated execution of relevant clinical trials:

-Michael Peluso, M.D., MHS, Assistant Professor of Medicine, University of California, San Francisco
-Amy Proal, Ph.D., Co-Founder and CEO, Polybio Research Foundation and Scientific Director, CoRE Clinic
-David Putrino, Ph.D., Nash Family Director of the CoRE clinic and Professor, Icahn School of Medicine at Mount Sinai

5/ The group was initiated in response to a growing number of case reports from across the U.S. suggesting meaningful symptom relief of Long COVID following use of PEMGARDA® (pemivibart), a mAb currently authorized by the FDA for the pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals.

6/ 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 viral material may drive disease in some patients, and that reducing this burden through mAb therapy may offer a promising therapeutic approach worthy of rigorous clinical investigation.

7/ 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.

8/ “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.”

9/ “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.”