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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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