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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.