In the earliest days of the COVID-19 pandemic, a suite of drugmakers looked to monoclonal antibodies to fight the immune system overreaction seen in severe patients. Months later, most of those candidates have had mixed success, but Humanigen is pressing ahead—and it's bringing on partners to help scale for market.
Humanigen has tapped Thermo Fisher Scientific to help scale up manufacturing of the California biotech's lenlizumab, a clinical-stage candidate for cytokine storm that the company is testing in severe COVID-19 patients for a possible emergency use approval later this year.
Humanigen's tie-up with Thermo Fisher is the company's third major manufacturing pact alongside recently signed deals with Lonza and Catalent for lenzilumab, which is currently in phase 3 testing.
Lenzilumab, a monoclonal antibody that targets the granulocyte macrophage colony-stimulating factor cytokine, has shown promise as a possible therapy for COVID-19 by stopping the immune system overreaction that leads to acute respiratory distress syndrome (ARDS) in COVID patients, Humanigen said.
Thermo Fisher will begin the technology transfer for the lenzilumab platform immediately, Humanigen said, and could be ready for commercial production as soon as this winter. In a release, Humanigen said the pact would allow it to pursue an "aggressive" commercial strategy if the drug receives the FDA's emergency use authorization.
Although relatively quiet among the possible therapies for COVID-19, lenzilumab is one of a group of monoclonal antibodies that have been tested during the pandemic—mostly with mixed results.
Most recently, Roche's Actemra posted data showing the drug used alongside standard of care reduced the risk of COVID-19 pneumonia patients advancing to mechanical ventilation or death by 44%, the drugmaker said this month.
Roche will share data from that study with health authorities, but a previous trial failure in severe patients could keep the once-promising candidate out of patients' hands.
Also this month, Sanofi and Regeneron ended clinical trials of IL-6 inhibitor Kevzara after a 420-patient study didn't meet its endpoints. Patients who received the medicine did experience slightly shorter hospital stays and speedier improvements in their condition versus placebo, but the results weren’t statistically significant.
With the road to approval uncertain, Humanigen can take solace in a manufacturing partner like Thermo Fisher, which is already playing a role in the COVID-19 response.
In May, Thermo Fisher won a contract with the U.S. government to produce viral transport media tubes to carry COVID-19 test samples to laboratories. Thermo Fisher has expanded its manufacturing capacity to 1 million media-filled tubes per week to meet increased demand for COVID-19 testing, the company said, including its U.S. contract.