Michael Handley, Statera Biopharma CEO

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.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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