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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.