Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback
- Pathway leverages immunobridging approach via serum virus neutralizing antibody (sVNA) titers enabled by prior successful COVID-19 treatment clinical trial "STAMP" conducted with prototype antibody adintrevimab
- Company anticipates submitting a COVID-19 treatment EUA application for PEMGARDA™ (pemivibart) imminently
- COVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibart
- Invivyd leaves 2024 net product revenue and year-end cash guidance unchanged although potential near-term COVID-19 treatment EUA and associated commercial dynamics were not considered
- Further details on upcoming 1Q 2024 results call on May 9, 2024
WALTHAM, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced its intention to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway. This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19. The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology.
"We are glad to once again align with the FDA on a rapid pathway towards addressing a critical unmet medical need among immunocompromised people who may benefit from alternative approaches to treating their symptomatic COVID-19. In the past, immunoglobulin G (IgG) mAbs targeting the receptor binding domain (RBD) of the SARS-CoV-2 spike protein have been highly effective therapeutic options for symptomatic COVID-19, and we are happy to leverage our prior success and proprietary technology with the aim to serve both prevention and now treatment of symptomatic disease for immunocompromised people as soon as possible," commented Marc Elia, Chairman of the Invivyd Board of Directors. "Our current manufacturing plan contemplates approximately one hundred thousand doses available through the second half of 2024 and anticipated seasonal uptick in circulating virus to serve both PrEP and potential treatment uses. We are currently considering options to expand and accelerate product availability."
"Treatment of active COVID-19 infection, which presents a substantial risk to immunocompromised patients, is a medical context well suited for an infused antibody therapy, as prior COVID-19 treatment mAbs were generally provided via intravenous (IV) infusion to enhance the speed at which antiviral titers are delivered to patients in need," said Mark Wingertzahn, SVP of Clinical Development and Medical Affairs. "We are moving with considerable urgency as we believe that immunobridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing our efforts with PrEP."
Observational studies have demonstrated that people who are immunocompromised continue to be disproportionally impacted by COVID-19-related hospitalizations and death.2-3 In addition to small molecule treatment options, where appropriate a monoclonal antibody may be a highly attractive option to alter the course of established infection.
"It's important to remember that SARS-CoV-2 still poses a major threat to many people, such as those who are significantly immunocompromised and at higher risk for severe outcomes if they develop a COVID-19 infection," said Brian Koffman, MDCM (retired), MS Ed, Co-Founder, Executive Vice President and Chief Medical Officer of the CLL (Chronic Lymphocytic Leukemia) Society. "For people who develop a COVID-19 infection, today's treatment options are not always adequate or clinically appropriate, especially for those who are immunocompromised and may be taking other drugs that are contraindicated for use with certain antivirals. For this vulnerable population, it would be extremely helpful to have a new monoclonal antibody as an option for treatment, a therapeutic approach that was shown during the earlier days of the pandemic to be highly effective against previous variants."
Invivyd is maintaining ...
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