Humanigen momentum barges on as Covid-19 candidate is selected for NIAID trial
One of “Pharma Bro” Martin Shkreli’s former biotechs came back from the dead during the Covid-19 pandemic thanks to its drug candidate targeting cytokine storms. Now, that company has scored itself a place in a NIAID-sponsored trial.
Humanigen $HGEN, trading for 46 cents per share as recently as mid-March, announced Monday afternoon that its lenzilumab will be tested in combination with remdesivir in NIAID’s Big Effect Trial, effectively categorizing it as a high-priority Covid-19 therapeutic candidate. The drug combo will be tested against remdesivir, a broad-spectrum antiviral that has shown in early studies to treat some symptoms of Covid-19, and a placebo.
Needless to say, Humanigen CEO Cameron Durrant is quite excited by the news.
“This is arguably the world’s foremost research for public health, government-supported organization,” Durrant told Endpoints News. “And they selected lenzilumab to be a participant in this program. We think that that’s extraordinarily validating.”
Durrant couldn’t comment on the timeline for the trial, citing the NIH’s sponsorship. NIAID couldn’t be immediately reached for requests to comment.
Before the pandemic, Humanigen was last in the news about three years ago when it was developing a drug to treat Chagas disease, but got beaten to the punch by a nonprofit group. What had been a promising program became a dud and sent investors fleeing.
But since mid-March, when companies around the world were looking at existing drugs to treat Covid-19, lenzilumab has been in the spotlight with its stock price up to nearly $5 per share — an almost 1,000 percent increase — in four months. Humanigen is currently engaging in its own Phase III trial, and Durrant insists this won’t be another mishap like three years ago.
Though a failure on Covid-19 here would likely pop this balloon instantly, the Chagas candidate “was a completely different program and completely in the rearview mirror. So, of course, we’re optimistic.”
Data for lenzilumab in Covid-19 treatment are fairly limited thus far; a non-controlled preprint of 12 patients with coronavirus-related severe pneumonia was released last month. In that study, 11 of those patients saw clinical improvements with an average time to discharge of five days, and they did not exhibit any serious adverse effects.
The California-based biotech’s main focus is cytokine storm research and it has been studying the efficacy of lenzilumab, a GM-CSF monoclonal antibody, in treating overactive immune responses seen in graft-versus-host disease and CAR-T cancer therapies. This mechanism has been a brighter spot in vaccine research than the competing Regeneron-backed IL-6 treatment, which suffered a setback in Phase II trials in late April.
Because Covid-19 exhibits a similar pathology to GvHD and CAR-T responses, Durrant said lenzilumab treatments could be applied to those infected by the coronavirus.
Back in 2015, Shkreli and an investment group bought a majority stake in the company, then known as KaloBios. When Shkreli was arrested for securities fraud, KaloBios fired him, declared bankruptcy and re-emerged as Humanigen in 2016.
On June 2, Humanigen scored $71.8 million in private equity to help fund its Phase III lenzilumab trials and scale the drug should it be approved.
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