Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.
Sometimes it takes a pandemic to resurrect a company fallen from grace. Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.
In Humanigen’s Phase III Trial, patients treated with lenzilumab had a 54% greater likelihood of survival without the need for mechanical ventilation compared to those receiving a placebo and other treatments.
The trial included 520 patients across 29 sites in the U.S. and Brazil. Each received three infusions of either the drug or a placebo, in addition to steroids and/or remdesivir. While the study was not designed to measure mortality difference, an improvement was observed with a favorable trend toward lenzilumab, 9.6% compared to 13.9% in the placebo arm.
“The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy,” said Zelalem Temesgen, M.D., Professor of Medicine at Mayo Clinic and Principal Investigator of the Phase III trial.
“Lenzilumab could make the difference between going on a ventilator, which reduces one’s chance of survival, and leaving the hospital alive.”
Humanigen CEO Cameron Durrant plans to submit an application to have lenzilumab approved for Emergency Use Authorization by the FDA “as soon as possible” and will be sharing results worldwide for approval.
While it is a monoclonal antibody, similar to the ones approved for use by Regeneron and Eli Lilly, lenzilumab is targeted at calming the “cytokine storm,” the immune overreaction that sparks the complications that most often lead to COVID-19 deaths. The drug was originally being developed for patients receiving CAR-T treatments for cancer, as they often fall victim to the dangerous cytokine storm in response.
In anticipation of approval, Humanigen has already been drumming up deals to support manufacturing and commercialization of the drug. Earlier this month, the company obtained a loan from Hercules Capital for up to $80 million for the task at hand. Avid Bioservices signed a manufacturing agreement with Humanigen in February to expand production capacity for lenzilumab. Agreements with multiple other CDMO’s have also been struck.
The positive news has done wonders for Humanigen’s stock. Trading for a measly $2 early last March, today the stock is up over 1000% a year later, trading around the $24 mark.
