Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flag­ship Pi­o­neer­ing has a fresh com­pa­ny out this week, one that aims to lay the ground­work for a whole new dis­ci­pline.

Sen­da Bio­sciences launched Wednes­day with $88 mil­lion in Flag­ship cash. The goal? Gain in­sights in­to the mol­e­c­u­lar con­nec­tions be­tween peo­ple and co­e­volved non­hu­man species like plants and bac­te­ria, paving the way for “In­ter­sys­tems Bi­ol­o­gy.”

Guil­laume Pfe­fer

Guil­laume Pfe­fer has been tapped to run the show, a 25-year biotech vet­er­an who comes from GSK af­ter lead­ing the de­vel­op­ment of the com­pa­ny’s shin­gles vac­cine.

“For Sen­da, we are zoom­ing in­to what’s go­ing on at hu­man lev­els, and we rec­og­nize that these in­ter­ac­tions are the prod­uct of evo­lu­tion since the dawn of time,” Pfe­fer told End­points News. “We know which species are in­volved in our bod­ies and where.”

A cen­ter­piece of Sen­da’s pro­pri­etary tech in­volves ma­chine learn­ing to cre­ate what the com­pa­ny hopes is an en­tire­ly new class of drugs. By fo­cus­ing in part on the bac­te­ria that re­side in hu­mans, Sen­da is look­ing at po­ten­tial­ly de­vel­op­ing large mol­e­cule med­i­cines like pep­tides and nu­cle­ic acids us­ing oral ad­min­is­tra­tion, which the com­pa­ny says is a first.

In­ter­sys­tems Bi­ol­o­gy has been in the works at Flag­ship for some time. The firm says the dis­ci­pline is based on a decade of re­search in oth­er ar­eas, in­clud­ing mi­cro­bio­me sci­ence and com­pu­ta­tion­al bi­ol­o­gy, and the cel­lu­lar in­ter­ac­tions Sen­da is an­a­lyz­ing can be found in sev­er­al dif­fer­ent places with­in the body.

“Through the ex­plo­rations con­duct­ed by Flag­ship Labs over the last sev­er­al years we have dis­cov­ered that these in­ter­con­nec­tions have pro­found im­pli­ca­tions on hu­man health,” Flag­ship founder Noubar Afe­fan told End­points News in an email.

One prime ex­am­ple is the neu­ro­trans­mit­ter sero­tonin, most of which is not found in the cen­tral ner­vous sys­tem but the gut. As much as 90% of sero­tonin is pro­duced in re­sponse to bac­te­ria break­ing down com­pounds with­in the di­ges­tive tract, Sen­da says, and if this reg­u­la­tion falls out of whack, it can lead to health prob­lems with both low and high blood sug­ar.

“With this ap­proach, you re­al­ize that we have a phar­ma­cy with­in us,” Pfe­fer said. “The key point is we have evolved with the bac­te­ria, and now with Sen­da are able to look with high res­o­lu­tion in­to how the species with­in us com­mu­ni­cate and par­tic­i­pate in dis­ease and health.”

David Berry

Sen­da cur­rent­ly has six on­go­ing pre­clin­i­cal pro­grams un­der its belt across mul­ti­ple ar­eas, with INDs ex­pect­ed for each by the end of 2022. In neu­rol­o­gy, Sen­da has can­di­dates in mul­ti­ple scle­ro­sis and Parkin­son’s dis­ease. For on­col­o­gy, they’re look­ing at im­muno-on­col­o­gy and col­orec­tal can­cer. And in chron­ic and meta­bol­ic dis­ease, the first tar­gets are chron­ic kid­ney dis­ease and obe­si­ty.

Specif­i­cal­ly, Pfe­fer men­tioned that Sen­da is look­ing at a bac­te­ria that in­ter­feres with L-dopa in the treat­ment of Parkin­son’s and at­tempt­ing to dis­rupt that process, thus mak­ing ther­a­pies more ef­fec­tive.

As Sen­da moves its six pre­clin­i­cal pro­grams for­ward, Pfe­fer’s goal is to con­tin­ue to de­ploy its dis­cov­ery en­gine in­to fur­ther in­di­ca­tions, set­ting up the com­pa­ny for more pro­grams once the proof of mech­a­nism has been es­tab­lished at the end of 2022.

“We are touch­ing on some­thing very fun­da­men­tal here and very pro­found,” Pfe­fer said.

The com­pa­ny was co-found­ed by sev­er­al mem­bers of Flag­ship’s team, in­clud­ing part­ners David Berry and Igna­cio Mar­tinez. Sen­da’s board will be chaired by Flag­ship’s ex­ec­u­tive part­ner John Mendlein.

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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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

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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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.