Michael Handley, Statera Biopharma CEO

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.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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UP­DAT­ED: FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.