Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.
“So, we do have experienced people, we have a decent network. We roll up our sleeves and do the unglamorous work,” said Cameron Durrant, Humanigen’s CEO.
Durrant, who earned extensive c-suite experience at Pharmacia Corp., Johnson & Johnson, Glaxosmithkline plc and Merck & Co. Inc., noted that it’s ironic that companies that can afford to take bigger risks often don’t.
“They have the infrastructure; they have the reputation. They should be taking more risks,” he added. “For a small company like us, if you make the wrong call, it can kill the company.”
So far, so good for Humanigen. At least this week. The new interim data in patients hospitalized with COVID-19 suggest the anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody had a clinically meaningful impact on patients’ recovery, with about 37% more patients recovered in the study’s lenzilumab arm when compared to the current standard of care.
“In our opinion, these data continue to position lenzilumab as the next frontline therapeutic supplementing current standard of care for those with COVID-19 and CRS,” H.C. Wainwright and Co. analyst Joseph Pantginis wrote Nov. 6.
That success brings more responsibility, as the data safety monitoring board now recommends increasing the study’s target of recoveries from 257 to 402. As Humanigen sees it, the move ensures an even higher probability of success in hitting the double blind study’s primary endpoint, which is time to recovery in a time frame of up to 28 days.
Lenzilumab is one of the few treatment options in development for COVID-19 to reach phase III trials. Humanigen execs have said they believe the drug’s mechanism of action as an immunomodulator could work very nicely with remdesivir and potentially enhance first-line standard-of-care therapy to prevent serious and potentially fatal outcomes.
The company also signed a cooperative R&D agreement with the Department of Defense to support lenzilumab’s ongoing phase III clinical trials for preventing and treating cytokine storm, thought to be a leading cause of COVID-19 patients’ deaths. That help includes offering up regulatory subject matter experts and help with statistics to prep for applying for an emergency use authorization in the first quarter of 2021, and then generating a BLA submission.
“That means in a practical sense, there will be staff who will come from the FDA, for example, to work with us to prepare documents for the FDA,” Durrant said. “But they are sitting on our side of the table. We think that is hugely valuable to have people who have knowledge of the ins and outs to help us prepare these documents.”
The government assist also includes lenzilumab being chosen by the NIH to be evaluated alongside other potential COVID-19 therapies in the ACTIV-5 clinical trial to be held at as many as 40 sites across the U.S. The platform trial is a series of randomized, double-blind, placebo-controlled studies intended as proof of concept research. It is designed to compare different investigational therapeutic agents to a common control arm and determine which ones have relatively large effects, which could possibly move them quickly into larger studies.
The trial, to be fully funded by the NIH, for treating COVID-19 will evaluate the combination of Gilead Sciences Inc.’s remdesivir with lenzilumab vs. remdesivir with a lenzilumab placebo.
These two steps for Humanigen were preceded by another for the drug and the company from earlier in the week. On Nov. 4, in a $20 million deal, Humanigen executed its first Asia-Pacific region licensing agreement. Telcon RF Pharmaceuticals Inc. and KPM Tech Co. Ltd. received the development and commercialization rights to lenzilumab for COVID-19 in south Korea and the Philippines.
The licensing agreement provides Humanigen with $6 million as an up-front payment upon execution, with the balance of $14 million to be paid in two payments based on achievement by Humanigen for specified milestones in the U.S. Humanigen also stands to earn double-digit royalties on net sales subsequent to commercialization.
The company’s stock (NASDAQ:HGEN) rose 4.64% on Nov. 6, with shares closing at $11.72 each.