Sol Bar­er

A few weeks ago, Johns Hop­kins Pro­fes­sor Jonathan Sch­neck pub­lished new re­search show­ing how the bio­mimet­ic nano beads he had cre­at­ed in the lab could work with a check­point in­hibitor in fight­ing can­cer. These beads were de­signed to act as anti­gen pre­sent­ing cells aimed at whip­ping up a full scale killer T cell at­tack on can­cer as the check­point stripped the can­cer cells of their built-in de­fense sys­tem.

That work Sch­neck did is held by a Johns Hop­kins biotech spin­out he cre­at­ed called Nex­Im­mune, which Cel­gene co-founder and se­r­i­al biotech start­up mas­ter Sol Bar­er just ac­quired.

Bar­er, Joshua Bar­er and for­mer Medtron­ic CEO William A. Hawkins got to­geth­er with some oth­er in­vestors to ac­quire the com­pa­ny for an un­spec­i­fied amount. And they brought in a new board to run the place. They in­clude some key play­ers in biotech:

Bar­er — who sur­faced just days ago as the new­ly named chair­man of Te­va as the Is­raeli com­pa­ny strug­gles through its lat­est ex­is­ten­tial cri­sis — has been do­ing deals on a string of small, pri­vate biotechs with in­ter­est­ing tech.

He grouped four biotechs in­to a com­pa­ny called Restor­Genex and quick­ly sold it to Dif­fu­sion, co-found­ed Cen­trex­ion with Jeff Kindler and chaired Cere­cor be­fore step­ping down in 2015. He al­so sits on the boards of Am­i­cus Ther­a­peu­tics and Aege­ri­on Phar­ma­ceu­ti­cals.

“I am ex­cit­ed to sup­port Nex­Im­mune’s ad­vance­ment of this im­por­tant im­munother­a­py-based tech­nol­o­gy,” Bar­er, the lead in­vestor in the ac­qui­si­tion, said in a pre­pared state­ment. “I be­lieve that the AIM nan­otech­nol­o­gy plat­form has the po­ten­tial to de­liv­er the next gen­er­a­tion of im­muno-on­col­o­gy treat­ment, bring­ing new hope to pa­tients suf­fer­ing from many types of ma­lig­nan­cies.”

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.