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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.