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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

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

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

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