Humanigen Announces Cooperative Research and Development Agreement with the U.S. government to Develop Lenzilumab for COVID-19
November 6, 2020
The Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) supports the development of lenzilumab as a potential treatment for patients with Covid-19
Humanigen’s development efforts complemented by full-scale, integrated team of federal leading experts dedicated to advancing lenzilumab ahead of a potential Emergency Use Authorization (EUA) submission
Burlingame, CA – November 6, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called a cytokine storm with its lead drug candidate lenzilumab™, today announced that the company and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) have entered into a Cooperative Research and Development Agreement (CRADA) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, to help meet the federal government’s Operation Warp Speed goals. The agreement supports development of lenzilumab in advance of a potential Emergency Use Authorization (EUA) for COVID-19.
The CRADA complements Humanigen’s development efforts, providing access to a full-scale, integrated team of manufacturing and regulatory subject matter experts and statistical support in anticipation of applying for EUA and subsequently a Biologics License Application (BLA) for lenzilumab as a potential treatment for COVID-19. The CRADA also provides that federal experts will work hand-in-hand with the company on U.S. Food and Drug Administration (FDA) communications, meetings and regulatory filings. The CRADA aims to support the ongoing lenzilumab Phase 3 clinical trials, focusing on efficiently generating EUA and BLA submissions. In addition to providing access under EUA, the CRADA allows for lenzliumab to possibly receive the benefits provided by Public Law 115-92.
Humanigen's investigational treatment lenzilumab, a proprietary Humaneered®anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is designed to prevent and treat an immune hyper-response called a cytokine storm, a complication considered to be a leading cause of COVID-19 death. Data showed that up to 89 percent of hospitalized patients with COVID-19 are at risk of this immune hyper-response, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
Cameron Durrant, MD, MBA, chief executive officer of Humanigen said, “We are honored to be part of Operation Warp Speed, receive this CRADA, and collaborate with JPEO-CBRND to advance lenzilumab as a potential response treatment and seek a potential EUA. We have been working tirelessly to advance lenzilumab for COVID-19 and are excited to have the integrated expert team at OWS prioritize lenzilumab research and development during this critical time.”
Lenzilumab was also selected by the National Institutes of Health (NIH) to be evaluated among the promising COVID-19 agents for its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) which will enroll patients at up to 40 sites in the U.S.
More details on Humanigen’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab. Details on the U.S. Phase 3 lenzilumab clinical trialcan be found at clinicaltrials.gov using Identifier NCT04351152. Details on ACTIV-5/BET can be found
atclinicaltrials.gov using Identifier NCT04583969.
It is worth note that Four Coronavirus types already occur & none have a vaccine .
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