Take­da part­ners with an up­start drugs-from-bugs mi­cro­bio­me play­er in­spired by a fe­cal trans­plan­ta­tion biz


Back when Mark Smith was work­ing on his PhD at MIT about 6 years ago, his girl­friend’s cousin was in­fect­ed with C.diff. Af­ter 7 re­oc­cur­rences fol­low­ing treat­ment with van­comycin, though, the cousin fi­nal­ly beat it by get­ting a fe­cal trans­plant, with his room­mate as the donor.

That in­ci­dent both in­trigued him and in­spired Smith’s first jump in­to a start­up, Open­Bio­me, which us­es screened fe­cal sam­ples for a more sys­tem­at­ic ap­proach in cre­at­ing a safe, re­li­able sup­ply of trans­plants to a grow­ing mar­ket.

Smith’s sec­ond start­up was a nat­ur­al ex­ten­sion of the first ven­ture: Finch Ther­a­peu­tics, a mi­cro­bio­me com­pa­ny which is de­vel­op­ing new drugs-from-bugs — an ap­proach which has helped in­spire a ros­ter of star­tups over the last two years. And to­day, the low-pro­file biotech — which has mush­roomed overnight in Somerville, MA in­to a 65-em­ploy­ee com­pa­ny that’s deeply en­gaged in man­u­fac­tur­ing work and fo­cus­ing on two de­vel­op­ment pro­grams – is un­veil­ing its first in­dus­try part­ner­ship.

Take­da, the Japan­ese phar­ma com­pa­ny with a grow­ing Boston R&D op­er­a­tion, is pay­ing $10 mil­lion up front on a very ear­ly-stage deal to part­ner on FIN-524, a pre­clin­i­cal pro­gram for IBD.

Work­ing with col­leagues at MIT, Smith has been work­ing on a “suite of al­go­rithms to ap­ply to da­ta on fe­cal trans­plan­ta­tion, to re­verse en­gi­neer ef­fec­tive ther­a­pies, then iden­ti­fy with com­pu­ta­tion­al ap­proach­es which bugs dri­ve clin­i­cal re­spons­es.”

“The core of our com­pa­ny is built around hu­man-first dis­cov­ery,” says Smith. While ri­vals look to an­i­mal mod­els to val­i­date their ideas, Finch li­censed a data­base de­rived from 22,000 pa­tients at Open­Bio­me dosed with fe­cal trans­plan­ta­tion. If they see an in­ter­est­ing phe­no­type, they can “se­quence the sam­ple, look at the or­gan­isms gen­er­at­ing a re­sponse, and go back to the freez­er and pull the strain.”

You start with some­thing that works, like fe­cal trans­plan­ta­tion, says Smith, and then work back­wards to get a drug. That is how they came up with the lead pro­gram for C.diff, now head­ed in­to a Phase II study.

Why 65 work­ers at this stage? Smith ex­plains that 40 staffers in­volved in man­u­fac­tur­ing at Open­Bio­me came over to the spin­out.

Ten mil­lion dol­lars isn’t a huge amount of cash in the biotech busi­ness. But Smith has man­aged to start a com­pa­ny and get in­to pipeline build­ing with­out hand­ing over a lot of eq­ui­ty to the VCs. He start­ed with an­gel mon­ey, then raised $5.5 mil­lion in an A round, and is now work­ing on a siz­able se­ries B. That $10 mil­lion from Take­da — along with an un­de­fined pack­age of mile­stones — goes a long way to fund their growth.

The Take­da pro­gram prob­a­bly has two-and-a-half to three years to go be­fore they hit the clin­ic, Smith adds, tar­get­ing ul­cer­a­tive col­i­tis.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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