Jason Campagna, Q32 Bio CMO (file photo)

Ex­clu­sive: For­mer In­ter­cept CMO lands new gig at Q32 Bio, two weeks af­ter leav­ing the NASH biotech

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

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.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

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.