Take­da dou­bles down on Finch's mi­cro­bio­me in­sights, sign­ing up for a sec­ond project in Crohn's dis­ease

Take­da first shone a spot­light on Finch Ther­a­peu­tics’ hu­man-first dis­cov­ery plat­form in 2017, when the Japan­ese phar­ma paid $10 mil­lion to part­ner a pre­clin­i­cal ul­cer­a­tive col­i­tis pro­gram in­spired by fe­cal trans­plan­ta­tion. While the mi­cro­bio­me ther­a­py, FIN-524, is still mak­ing its way to the clin­ic, Take­da has seen enough to com­mit to a sec­ond pro­gram tack­ling an­oth­er type of in­flam­ma­to­ry bow­el dis­ease.

Mark Smith

The duo will now rev up Finch’s plat­form tech again in search of a treat­ment for Crohn’s dis­ease, which Take­da will have ex­clu­sive rights to com­mer­cial­ize. Fi­nan­cial terms were not dis­closed.

De­ploy­ing ma­chine learn­ing to crawl through da­ta from in­ter­ven­tion­al mi­cro­bio­ta trans­plan­ta­tion stud­ies, Finch CEO Mark Smith aims to iden­ti­fy mean­ing­ful mi­cro­bial sig­na­tures por­tend­ing dis­ease. The re­sult is what he calls ra­tio­nal­ly-se­lect­ed mi­cro­bio­ta ther­a­pies, which con­tain cul­tured bac­te­r­i­al strains linked to pos­i­tive clin­i­cal out­comes.

That ap­proach could prove su­pe­ri­or to an­i­mal mod­els, Finch the­o­rizes. FIN-524 was their first at­tempt to val­i­date the the­o­ry — as the two oth­er can­di­dates in their pipeline, for re­cur­rent C. diff and autism, came from its oth­er dis­cov­ery plat­form. Known as full-spec­trum mi­cro­bio­ta, it rep­re­sents the foun­da­tion­al “drugs from bugs” idea of putting good bac­te­ria in a pill.

Gareth Hicks

“We’ve seen the promise of Finch’s Hu­man-First Dis­cov­ery plat­form for the de­vel­op­ment of a com­plete­ly new type of treat­ment for in­flam­ma­to­ry bow­el dis­ease,” said Gareth Hicks, head of gas­troen­terol­o­gy drug dis­cov­ery unit at Take­da, in a state­ment.

Hicks is in charge of one of four core ther­a­peu­tic ar­eas that Take­da is ze­ro­ing in on in the wake of the Shire ac­qui­si­tion (the oth­er three be­ing on­col­o­gy, neu­ro­science and rare dis­eases). Right now, one of the stars in the port­fo­lio is En­tyvio, an IBD drug that blocks the bind­ing of α₄β₇ in­te­grin to in­testi­nal mu­cos­al ad­dressin cell ad­he­sion mol­e­cule 1 (MAd­CAM-1), there­by ame­lio­rat­ing the in­flam­ma­to­ry ef­fect of white blood cells on gut tis­sues.

The col­lab­o­ra­tion with Finch isn’t their on­ly push in­to the nascent but fe­cund field of mi­cro­bio­me-based ther­a­peu­tics. Last Oc­to­ber Take­da put down $50 mil­lion to team up with France’s En­terome on EB8018, a small mol­e­cule de­signed to se­lec­tive­ly dis­arm vir­u­lent bac­te­ria in the gut caus­ing in­flam­ma­tion, with­out dis­rupt­ing the lo­cal mi­cro­bio­me.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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John Houston, Arvinas CEO

Pfiz­er bets $1B cash on the orig­i­nal pro­tein de­graders as tech­nol­o­gy nears prime time

As one of the largest multinational corporations in the world, Pfizer has its tendrils in everything. The Big Pharma has potentially hundreds of billions of dollars to play with, and when it decides to go big, it can go as big as it wants.

And did Pfizer ever on Thursday.

Returning to one of its partners in protein degradation, Pfizer is teaming up again with Arvinas to advance and vastly expand a program for breast cancer. As part of the deal, Pfizer is handing over $1 billion immediately — $650 million in upfront cash and $350 million in an equity investment — and promising up to another $1.4 billion in regulatory and commercial milestones.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.