UPDATED: Statera Biopharma gets the OK to resume the study of a potential stockpile drug for lethal radiation exposure
Last summer, when Cytocom merged with Cleveland BioLabs to grab a spot on Nasdaq, it also inherited an intriguing rare disease program that was under clinical hold. With a new name and brand, the company says it’s ready to bring that program back to the forefront.
The FDA has lifted its clinical hold on entolimod, a toll-like receptor 5 (TLR5) agonist being developed for patients exposed to lethal amounts of radiation, the company — now called Statera Biopharma — announced on Wednesday.
As a result, the Colorado-based biotech’s stock $STAB saw a 1% boost in premarket trading, before sinking about 7% in early morning trading.
Acute radiation syndrome (ARS) occurs when the whole body is exposed to extremely high amounts of radiation over a short period of time — for example, those who survived the Hiroshima and Nagasaki atomic bombs, or firefighters that responded at Chernobyl. Cleveland BioLabs was working on a treatment that could counteract the effects of radiation exposure in worst-case scenarios.
“It would be a stockpiling agent,” Statera CEO Michael Handley told Endpoints News on Wednesday. “So governments, including the US government and around the world, would order it and stockpile it in the case of, God forbid, a nuclear reactor meltdown or even worse, nuclear warfare … So you store, stack it up and hope you never use it.”
Although Cleveland BioLabs couldn’t test entolimod’s efficacy in humans, the FDA’s Animal Rule allows researchers to prove a drug works in animals in very specific circumstances where human trials would be unethical. The company had been preparing to file for an EUA when it was slapped with a clinical hold in late 2019 over “recommendations for design revisions,” according to a 10-K filing.
“From my knowledge of the historical program, the FDA was requiring additional rhesus monkey studies for efficacy to confirm the efficacy in the original primate studies,” Handley said during the interview. “This was a protocol clarification, to get the FDA to sign on to completing just an additional efficacy study to move forward with (the) ARS indication.”
Statera reached out again later to add the following statement:
The clinical hold was placed because FDA wanted to ensure subject safety in the proposed clinical trial. The FDA requested the addition of an independent data monitoring committee and a few tweaks to the design of the study. Statera was happy to comply with these requests as we agree that they add protection for the patients. Once the protocol was amended to include the FDA requests, FDA lifted the clinical hold.
The company said it was misstated that additional monkey studies were needed, and that the study in question was actually “a human study also to eventually support a BLA.”
Around the same time that entolimod was hit with the clinical hold, CEO Yakov Kogan gave his resignation, and vice president of finance Christopher Zosh stepped up to lead the company in the interim.
Things were looking down, until immunomodulation-focused Cytocom struck a deal last year to reverse merge with the biotech to snag a spot on Nasdaq. Though the new company kept Cytocom’s name, they kept entolimod up their sleeve. Meanwhile, the focus shifted to Cytocom’s four late-stage programs for Crohn’s disease, fibromyalgia, multiple sclerosis and pancreatic cancer. The lead program, STAT-201, is expected to enter a Phase III study in Crohn’s disease next quarter, Handley said.
This past summer, the company rebranded to Statera, the Latin word for “balance,” in reference to modulating the immune system.
Handley isn’t quite sure if Statera will pursue an EUA for entolimod, adding that the first step will be to conduct the additional advocacy study. They also plan on launching the candidate in a Phase I/II program in hematology next year.
This story has been updated with additional comment from Statera.