Humanigen Inks COVID-19 Drug Development Agreement With US Defense Department

By Reuters Staff

November 09, 2020

(Reuters) - Humanigen Inc has partnered with the U.S. government to help advance development of its drug candidate as a potential COVID-19 treatment following positive response in hospitalized patients in a late-stage study, the company said on Friday.

Patients receiving the drug, lenzilumab, saw 37% more recovery as compared to current standard of care in the study, which aims to determine whether the drug can prevent and treat an immune hyper-response called "cytokine storm".

The tie-up with the defense department is part of the U.S. government's Operation Warp Speed, which has struck deals with several other drugmakers to help speed up the development of a possible COVID-19 treatment.

Humanigen's shares rose 13% in premarket trading after the company said it plans to file for an emergency use approval (EUA) in the first quarter of 2021, either following interim data at 75% or at study completion.

Lenzilumab has been selected by the National Institutes of Health to be evaluated alongside Gilead Sciences' COVID-19 drug candidate, remdesivir, which received the U.S. Food and Drug Administration's approval for treating patients hospitalized with COVID-19.

Lenzilumab belongs to a class of drugs known as monoclonal antibodies, similar to the ones being developed by Regeneron Pharmaceuticals and Eli Lilly for COVID-19. Treatments from Lilly and Regeneron are being considered by the health regulator for EUAs.

Following the recommendation of an independent safety board, Humanigen plans to increase enrollment to the study to ensure higher probability of meeting the main goal.

The next interim data analysis is planned for when the study enrolls about 390 patients, the company said.

The agreement, which is in collaboration with the U.S. Department of Health and Human Services, will support an ongoing late-stage trial of lenzilumab.

Financial terms of the deal were not disclosed.