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.