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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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