Lau­rence Coop­er

A lit­tle over a year af­ter fac­ing an ac­tivist at­tack that saw for­mer CEO Lau­rence Coop­er sur­vive but re­tire a few months lat­er, Zio­pharm On­col­o­gy will un­der­go a re­brand­ing and re­struc­tur­ing.

Its new com­pa­ny name will be Alaunos Ther­a­peu­tics, the biotech an­nounced Thurs­day, aim­ing to put its check­ered past be­hind it. In ad­di­tion, Alaunos has closed its Boston of­fice and will move its head­quar­ters to Hous­ton — it’s un­clear whether this will re­sult in sub­stan­tial lay­offs.

The move comes af­ter the new CEO, Kevin Boyle, took the reins in Sep­tem­ber.

“Over the course of 2022, the team will con­tin­ue to work dili­gent­ly with an ex­e­cu­tion mind­set to de­liv­er re­sults,” Boyle said in a state­ment. “Our name change to Alaunos Ther­a­peu­tics re­flects the com­ple­tion of our tran­si­tion to a TCR-T fo­cused com­pa­ny and em­bod­ies our mis­sion of de­vel­op­ing nov­el ther­a­pies for can­cer pa­tients.”

Back in No­vem­ber 2020, then-Zio­pharm tried to with­stand an ac­tivist at­tack from Wa­ter­Mill As­set Man­age­ment Corp, which at­tempt­ed to oust half the com­pa­ny’s eight-mem­ber board and Coop­er. The end re­sult proved some­what suc­cess­ful for Wa­ter­Mill, as it se­cured the elec­tion of two board mem­bers but failed to oust Coop­er.

One board mem­ber that didn’t make it on at the time was Wa­ter­Mill CEO Robert Post­ma, though he even­tu­al­ly joined the board soon af­ter. In Feb­ru­ary, Coop­er stepped down from his post and Boyle, who had the en­dorse­ment of Post­ma, was lat­er ap­point­ed chief ex­ec­u­tive af­ter a six-month search.

Alaunos re­cent­ly launched en­roll­ment for a Phase I/II study for its new lead pro­gram, us­ing its tech­nol­o­gy to “eval­u­ate 10 unique TCRs tar­get­ing KRAS, TP53 and EGFR mu­ta­tions in pa­tients across a broad range of sol­id tu­mors,” the com­pa­ny said Thurs­day. An in­ter­im da­ta up­date is ex­pect­ed some­time lat­er this year.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.