Statera Biopharma gets the OK to resume the study of a potential stockpile drug for lethal radiation exposure

Michael Handley, Statera Biopharma CEO

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. ‘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.’

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.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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Jeff Baxter, VBI Vaccines CEO (ChromaDex)

VBI Vaccines celebrated a new approval Wednesday morning, announcing the FDA has greenlighted its hepatitis B vaccine for adults. But questions remain on how well the new shot will sell.

The biotech intends to hit the market in the first quarter of next year, joining three other adult hepatitis B vaccines from Merck, Dynavax and GlaxoSmithKline. CEO Jeff Baxter said in an analyst call Wednesday the price of VBI’s shot, branded as PreHevbrio, won’t be revealed until commercialization, but claimed it would be ‘highly competitive.’

Philip Dormitzer, new GSK global head of vaccines R&D

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.
https://endpts.com/statera-biopharma-gets-the-ok-to-resume-the-study-of-a-potential-stockpile-drug-for-lethal-radiation-exposure/