Humanigen On the Cusp of Filing for Lenzilumab EUA in Hospitalized COVID-19 Patients

Lenzilumab_Courtesy of Humanigen

Photo courtesy of Humanigen

In its first-quarter report, Humanigen announced it had “recently held a meeting with FDA” to discuss plans for filing an Emergency Use Authorization (EUA) for its lenzilumab for hospitalized, hypoxic COVID-19 patients by the end of May.

On May 5, the company published data from its Phase III study in hospitalized COVID-19 patients. The data had initially been announced on March 29. And on April 20, they reported data from their Phase Ib ZUMA-19 trial of the same drug in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). The drug is being evaluated for its ability to control the hyper-immune response known as a cytokine storm. 

The cytokine storm is a known potential side effect of CAR-T immuno-oncology therapies and one of the deadliest aspects of COVID-19.

“We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application,” said Cameron Durrant, chief executive officer of Humanigen. “We successfully completed our Phase III study of lenzilumab, referred to as LIVE-AIR, for the treatment of newly hospitalized and hypoxic COVID-19 patients. The trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need of IMV [intermittent mandatory ventilation] compared with patients receiving placebo and other treatments. We believe this statistically significant result, along with data regarding additional endpoints and further analysis from the study, support the submission of applications for emergency use authorization to the U.S. Food and Drug Administration and conditional marketing authorization in the United Kingdom and the European Union.”

Lenzilumab targets GM-CSF, a cytokine linked to poor outcomes in COVID-19 patients. In the study, they randomized 520 hospitalized COVID-19 patients to receive either lenzilumab or placebo as well as standard-of-care such as dexamethasone or Gilead’s remdesivir (Veklury). 

Humanigen also reported positive data from its Phase I trial of ifabotuzumab in glioblastoma multiforme. With the positive Phase Ib data of lenzilumab in DLBCL, the company terminated its clinical collaboration deal with Kite, a Gilead Company, and announced plans to launch a Phase II trial with all commercially available CD19 CAR-T therapies for DLBCL patients.

At the time, Cameron said, “Humanigen is pleased to be in a position to proactively develop lenzilumab across the CAR-T landscape and further expand its pipeline. We thank Kite for their sponsorship and contribution that has allowed Humanigen to progress to this exciting point.”

From a financial perspective, the company reported license revenue of $486,000 for the quarter, with cash and cash equivalents as of March 31 of $92.892 million. Net cash for the quarter was $35.8 million. 

Humanigen launched a public offering of common stock during the quarter, which brought in $94.1 million. It also entered into a loan facility with Hercules Capital that will secure about $80 million of debt financing. 

To prepare for the potential launch under the EUA and conditional marketing authorization (CMA), Humanigen inked several supply deals with contract manufacturing organizations to supply bulk drugs, fill/finish, and commercial packaging.

In premarket trading, Humanigen shares climbed 13% at the news.

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