CEO James Rosen (Artizan)

Pre­ci­sion in­flam­ma­tion drugs? Yale spin­out Ar­ti­zan clinch­es $11M and Bio­haven deal to sin­gle out bad bac­te­ria

As a Yale spin­out based in New Haven, Ar­ti­zan Bio­sciences was pret­ty fa­mil­iar with Bio­haven — a suc­cess­ful neu­ro-fo­cused drug de­vel­op­er and “shin­ing star,” as Ar­ti­zan CEO James Rosen puts it, in the bur­geon­ing biotech com­mu­ni­ty there.

But when a board di­rec­tor and an in­vestor tried con­nect­ing the two, they were in for a sur­prise.

“Un­be­knownst to Ar­ti­zan, Bio­haven had been do­ing a land­scap­ing ex­er­cise sur­vey­ing mi­cro­bio­me com­pa­nies with whom to part­ner for CNS dis­or­ders,” Rosen told End­points News, “and lo and be­hold, they found Ar­ti­zan right in their back­yard.”

Found­ed by Richard Flavell, Noah Palm and Mar­cel de Zoete, the biotech had been ap­ply­ing a method they pi­o­neered to iden­ti­fy dis­ease-caus­ing bac­te­ria. The plat­form scans bac­te­r­i­al strains for an an­ti­body coat­ing known as im­muno­glo­bin A (IgA) — a nat­ur­al im­mune re­sponse that sig­nals it’s bad bac­te­ria.

Bio­haven end­ed up sign­ing on for an op­tion to li­cense the in­flam­ma­to­ry bow­el dis­ease pro­grams Ar­ti­zan is al­ready de­vel­op­ing, and al­so as a part­ner to a new line of dis­cov­ery work along the gut brain ax­is.

It’s al­so lead­ing in an $11 mil­lion Se­ries A-2 along­side Hat­teras Ven­ture Part­ners, which had seed­ed Ar­ti­zan.

“One of the places we’re look­ing at most close­ly is dis­rup­tion of gut bar­ri­er in­tegri­ty,” Rosen said. “So when some of these mi­cro­bial con­tents are able to pierce the gut bar­ri­er, those in­testi­nal con­tents ei­ther in the form of bac­te­ria di­rect­ly or their vir­u­lence fac­tors or metabo­lites can get ex­po­sure to ei­ther cen­tral cir­cu­la­tion or get ex­po­sure to some of the com­po­nents of the ner­vous sys­tem that line the gut. The phys­i­o­log­i­cal re­sponse of the ner­vous sys­tem can be­come path­o­gen­ic.”

The goal is to repli­cate what they’ve al­ready done in IBD, where Ar­ti­zan’s 12 em­ploy­ees, work­ing with ex­ter­nal col­lab­o­ra­tors, had ze­roed in on a bug that’s heav­i­ly coat­ed with IgA, elu­ci­dat­ed its mech­a­nism and fig­ured out that it’s drug­gable by both small mol­e­cules and an­ti­bod­ies. Be­hind that, there are two oth­er bac­te­r­i­al strains they’d like to tar­get — ones that they be­lieve are se­cret­ing vir­u­lence fac­tors that in­duce in­flam­ma­tion and cause ul­cer­a­tion.

To­geth­er, ac­cord­ing to Rosen, these three strains are the cul­prit for half of all IBD cas­es.

“And so we be­lieve that for the pa­tients who will ben­e­fit from our ap­proach, it could ac­tu­al­ly be cu­ra­tive and restora­tive for their gut and the in­tegri­ty of their gut,” he added.

It would open the door for a pre­ci­sion med­i­cine ap­proach that’s been pop­u­lar­ized in on­col­o­gy to be ap­plied in IBD, with im­pli­ca­tions for pa­tient se­lec­tion in clin­i­cal tri­als. Once they de­clare a lead drug can­di­date lat­er this year and start plan­ning to en­ter the clin­ic at the end of 2022, Ar­ti­zan ex­pects to be able to screen pa­tients for the spe­cif­ic bac­te­r­i­al strain and vir­u­lence fac­tor they’re tar­get­ing. That way, they’d need much small­er tri­als to show an ef­fect.

By then, Ar­ti­zan will like­ly have raised a Se­ries B; Rosen ad­mits that the pan­dem­ic had thrown a wrench in­to their fundrais­ing plans, push­ing them in­to this in­ter­im step.

But he’s still op­ti­mistic, not­ing that the com­pounds gen­er­at­ed in the IBD pro­gram could be di­rect­ly ap­plied to oth­er dis­eases, there­by speed­ing things up. Af­ter proof-of-con­cept, Ar­ti­zan has al­so lined up a deal with Brii Bio to pick up de­vel­op­ment and com­mer­cial­iza­tion in Chi­na.

“We’re still ac­tive­ly look­ing for ad­di­tion­al part­ners in oth­er ther­a­peu­tic ar­eas,” he said, in­clud­ing on­col­o­gy, meta­bol­ic dis­or­ders and liv­er dis­ease.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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