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Humanigen, DoD to Develop COVID-19 Antibody Treatment
Researchers estimated that there were 37% more recoveries in patients who received the COVID-19 antibody treatment, lenzilumab, versus current standard of care.
Humanigen and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense recently entered into a Cooperative Research and Development Agreement (CRADA) to develop its potential COVID-19 antibody treatment, lenzilumab.
The CRADA complements Humanigen’s developmental COVID-19 efforts and ensures that federal experts work with the company on FDA meetings and regulatory filings, as well as provide comments on submission prior to submitting to FDA.
The Biomedical Advanced Research and Development Authority (BARDA) will also support the initiative, which will help further the federal government’s Operational Warp Speed goal to deliver a safe and effective vaccine to Americans by January 2021.
The public-private partnership was created to facilitate the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines, therapeutics, and diagnostics, between components of HHS.
“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,” Cameron Durrant, MD, MBA, chief executive officer of Humanigen, said in the announcement.
“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,” Durrant continued.
Humanigen is currently focusing on lenzilumab to treat cytokine storm, a common side effect of COVID-19 where the body starts to attack its own cells and tissues rather than fighting off the virus.
Currently, cytokine storm is one of the leading causes of COVID-19 death.
Humanigen’s CRADA aims to support the ongoing lenzilumab Phase 3 clinical trials, focusing on efficiently generating emergency use authorization and Biologics License Application submissions.
Previously, National Institutes of Health (NIH) selected lenzilumab 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 US.
At the end of October, Humanigen announced that the first patient was dosed in the ACTIV-5 clinical trial evaluating lenzilumab with remdesivir in patients hospitalized with COVID-19.
ACTIV-5 will determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19.
The information from the trial will determine if researchers need to push into larger clinical trials.
Most recently, the company announced that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37 percent more recoveries observed in patients who received lenzilumab versus the current standard of care.
Researchers stated that any observed benefit in the lenzilumab arm would be above the use of remdesivir or steroids, which are just a few of the drugs that have been used as potential COVID-19 treatments in both patients who received lenzilumab and patients who received a placebo.
Notably, no serious adverse events have been linked to lenzilumab. Despite these findings, Humanigen stated that it will increase enrollment to 515 patients to ensure a higher probability of success in meeting the primary endpoint.
“We believe the Phase 3 trial is significantly de-risked. Targeting 402 events improves the probability of success, maintains the power of the study at 90 percent, and further supports our plans for Emergency Use Authorization (EUA) and Biologics License Application (BLA) submission,” Dale Chappell, MD, MBA, chief scientific officer of Humanigen, said in the announcement last week.
“We are working to quickly activate additional trial sites across the U.S. to support rapid enrollment and increase access to lenzilumab with a continued commitment to inclusion and diversity,” said Chappell
Humanigen intends to file for an emergency use authorization in the first quarter of 2021, either following interim data at 75 percent or at study completion.
