Ar­ti­zan com­pletes mi­cro­bio­me starter pack­age with Brii deal, CSO hire and some mon­ey to dash for the clin­ic

Three years af­ter giv­ing a syn­op­sis of its mi­cro­bio­me play with some seed fund­ing from Ma­lin and Hat­teras Ven­ture Part­ners, Ar­ti­zan is rais­ing the cur­tain on their first act in in­flam­ma­to­ry bow­el dis­ease.

James Rosen Ar­ti­zan

Armed with $12 mil­lion in to­tal Se­ries A cash, a part­ner­ship with Chi­na’ Brii Bio and a new CSO hire, the New Haven, CT-based biotech is ready to hun­ker down for some pre­clin­i­cal work. Mean­while, CEO James Rosen tells me he will be get­ting to work rais­ing a Se­ries B in­tend­ed to fund clin­i­cal op­er­a­tions.

Yale im­muno­bi­ol­o­gy pro­fes­sor Richard Flavell and two col­lab­o­ra­tors pi­o­neered a new way to iden­ti­fy dis­ease-caus­ing bac­te­ria by scan­ning for an an­ti­body coat­ing called im­muno­glo­bin A (IgA). That was 2014.

“The coat­ing is our body’s at­tempt to neu­tral­ize the bac­te­ria,” Flavell said in 2014. “It binds to the bad bac­te­ria. We on­ly make these IgA re­spons­es to a lim­it­ed num­ber of or­gan­isms.”

It’s a more ef­fi­cient ap­proach than the tra­di­tion­al method of screen­ing for harm­ful bac­te­ria, which typ­i­cal­ly in­volves com­par­ing vast amounts of se­quenc­ing da­ta be­tween healthy and sick in­di­vid­u­als.

Richard Flavell Ar­ti­zan

Ze­ro­ing on the mi­crobes to tar­get, though, is on­ly the first step. Ar­ti­zan is look­ing in­to a num­ber of ways to get rid of them, from small mol­e­cules and an­ti­bod­ies to a ther­a­peu­tic vac­cine that could help the im­mune sys­tem mount a more po­tent at­tack.

Un­like some well-known play­ers in the mi­cro­bio­me field such as Seres and Finch, “we’re very specif­i­cal­ly not bugs as drugs,” Rosen said.

That opens up a broad range of po­ten­tial ap­pli­ca­tions for Ar­ti­zan’s plat­form, he said, as man­i­fest­ed in Brii’s de­ci­sion to col­lab­o­rate on up to three pro­grams. Brii — a $260 mil­lion pow­er biotech play spear­head­ed by GSK vet Zhi Hong — will pick up Chi­na de­vel­op­ment and com­mer­cial­iza­tion once Ar­ti­zan pro­duces proof-of-con­cept in the next cou­ple of years.

The deal comes with an undis­closed set of up­front, mile­stone and roy­al­ty pay­ments in ad­di­tion to a ven­ture in­vest­ment, plac­ing Brii in a syn­di­cate that in­cludes John­son & John­son De­vel­op­ment In­no­va­tion – JJDC, Os­age Uni­ver­si­ty Part­ners and Elm Street Ven­tures.

Paul Miller Syn­log­ic

Co­or­di­nat­ing the whole re­search ef­fort from dis­cov­ery to drug de­vel­op­ment and join­ing the 11-per­son team would be Paul Miller, the new chief sci­en­tif­ic of­fi­cer. Miller, a sea­soned ex­ec groomed in As­traZeneca and Pfiz­er, jumps from Syn­log­ic, which spe­cial­izes in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics.

“It’s an ex­cit­ing time to join Ar­ti­zan’s ef­forts to ad­dress the un­met treat­ment need in IBD, a dis­ease that af­fects more than 1.6 mil­lion Amer­i­cans,” Miller said in a state­ment.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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