Just two weeks ago, In­ter­cept CMO Ja­son Cam­pagna fol­lowed the biotech’s found­ing CEO out the door to pur­sue oth­er op­por­tu­ni­ties, per an SEC fil­ing, as an­a­lysts sense a ma­jor shift tak­ing place at the com­pa­ny. Now, that new op­por­tu­ni­ty has come to light.

Cam­pagna is tak­ing the same CMO po­si­tion at Q32 Bio, the com­pa­ny an­nounced Tues­day morn­ing, join­ing CEO Mike Brox­son’s team in Cam­bridge, MA as they ex­plore the next gen­er­a­tion of com­ple­ment drugs. The move comes af­ter Q32 pulled in two fundrais­ing rounds in 2020 to­tal­ing more than $100 mil­lion and as the biotech is in IND-en­abling stud­ies for its lead pro­gram, dubbed ADX-097.

Cam­pagna wouldn’t com­ment on the spec­u­la­tion around In­ter­cept’s in­ner-work­ings or fu­ture. Through a Q32 spokesper­son, Cam­pagna pre­emp­tive­ly de­clined com­ment Tues­day on all mat­ters re­lat­ed to his old com­pa­ny.

Brox­son and Cam­pagna live fair­ly close to one an­oth­er — “we could prob­a­bly throw a rock at each oth­er’s hous­es,” Cam­pagna told End­points News. They start­ed meet­ing for cof­fee some­time last fall, tak­ing ap­pro­pri­ate pan­dem­ic pre­cau­tions, and Cam­pagna said he was very di­rect with Brox­son in ask­ing how Q32’s pro­grams would ap­peal to pa­tients and doc­tors.

But what ul­ti­mate­ly stood out to the now-CMO was the da­ta Q32 had pro­duced in a mouse mod­el for its sys­temic drugs. The ques­tion sur­round­ing such pro­grams, Cam­pagna said, al­ways in­volves whether or not the drugs can get to the in­jured tis­sue when de­liv­ered sys­tem­i­cal­ly.

So as Cam­pagna re­calls it, Brox­son pulled out his iPad dur­ing one of their cof­fee meet­ings and showed him the goods. Not on­ly did the Q32 da­ta il­lus­trate a lack of off-site tox­i­c­i­ty, but they demon­strat­ed that the com­pounds can stay in the in­jured mouse tis­sue for about 10 days. That be­came the “linch­pin” of Cam­pagna’s think­ing, he said.

“If tis­sues in the body are not be­ing ex­posed to the com­pound, and pri­mar­i­ly ac­cu­mu­lat­ing where the in­jury is oc­cur­ring, you don’t get bet­ter than that in terms of get­ting a shot on goal,” Cam­pagna said. “I nev­er saw any­thing that ap­prox­i­mat­ed that kind of phar­ma­co­ki­net­ics. That was the mag­ic mo­ment.”

Q32 is shoot­ing for a reg­is­tra­tional fil­ing for ADX-097 some­time at the be­gin­ning of next year, but Brox­son told End­points it could come at the end of 2021. They’re look­ing at sev­er­al dis­eases to start, in­clud­ing some in the kid­neys as well as lu­pus. The goal with an ul­ti­mate Phase I tri­al is to es­tab­lish the same proof-of-mech­a­nism in hu­mans that Q32 saw in the mice.

Cam­pagna’s de­par­ture from In­ter­cept came rough­ly two and a half months af­ter the biotech abrupt­ly an­nounced found­ing CEO Mark Pruzan­s­ki had been re­placed at the helm. In­ter­cept em­pha­sized there was no “dis­agree­ment re­gard­ing any mat­ter re­lat­ed to the Com­pa­ny’s op­er­a­tions, poli­cies, or prac­tices” when Cam­pagna left.

Though an In­ter­cept spokesper­son de­nied to End­points two weeks ago that there was any shift, an­a­lysts are ask­ing whether the ex­its of Pruzan­s­ki and now Cam­pagna have prompt­ed the com­pa­ny to move away from its sig­na­ture NASH pro­grams in the wake of an FDA re­jec­tion last June. Cam­pagna had led In­ter­cept’s NASH ef­forts af­ter he was hired from The Med­i­cines Com­pa­ny in 2016, be­fore be­ing pro­mot­ed to CMO in 2019.

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 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.

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.