CEO Mark McKenna (Prometheus Biosciences)

Prometheus Bio is ready for its close-up shot, fol­low­ing a $130M round to back IBD drugs now head­ed to the clin­ic

A lit­tle over a year ago, Take­da lined up a deal to col­lab­o­rate with a low-pro­file San Diego up­start called Prometheus Bio­sciences on a string of new drugs for in­flam­ma­to­ry bow­el dis­ease. The phar­ma play­er tossed an undis­closed up­front and up to $420 mil­lion in mile­stones to get the al­liance start­ed.

These days, pre­clin­i­cal deals are com­mon, mile­stones are hazy mark­ers of fi­nan­cial health and the pact didn’t get a lot of at­ten­tion. But that ob­scu­ri­ty should start to dis­si­pate this week.

To­day, Prometheus, which had been cre­at­ed by the ac­qui­si­tion of Prometheus Labs by Pre­ci­sion IBD, is show­ing off a whop­ping $130 mil­lion raise from some fa­mil­iar biotech in­vestors jump­ing in to stretch the run­way at the 4-year-old pre­clin­i­cal biotech out in­to 2023, when CEO Mark McKen­na is promis­ing to have 3-4 IBD drugs ei­ther in the clin­ic or IND ready. The first of those clin­i­cal pro­grams is slat­ed to be­gin in a mat­ter of weeks, putting McKen­na’s team on track to their first round of hu­man da­ta.

Spun out of Cedars-Sinai Med­ical Cen­ter, the com­pa­ny built a con­sid­er­able por­tion of its sci­en­tif­ic foun­da­tion around the work of Stephan Tar­gan, an IBD spe­cial­ist who found­ed the IBD Cen­ter at the med­ical cen­ter some 28 years ago.

“We lever­aged this big da­ta set built over 20 years to iden­ti­fy new tar­gets in IBD and de­vel­op com­pan­ion di­ag­nos­tics for the drugs,” says McKen­na, cit­ing 20,000 sam­ples in the da­ta bank. Us­ing bioin­for­mat­ics tech, they have been work­ing on spot­light­ing tar­get­ed ther­a­peu­tics that can do bet­ter — in a much more durable fash­ion — than the cur­rent gen­er­a­tion of IBD drugs.

Their lead pro­gram — PRA023 — is an an­ti-TL1A an­ti­body. But they’re not alone. Pfiz­er has a sim­i­lar pro­gram. But McKen­na has am­bi­tions to build a broad pipeline around IBD.

“We be­lieve we can put out a new tar­get every year,” he tells me.

You may re­call that McKen­na spent a 4-year stretch fo­cused on Bausch sub Sal­ix Phar­ma­ceu­ti­cals, where he won ku­dos for the turn­around work he ac­com­plished there. Once seen as a pos­si­ble suc­ces­sor to Bausch chief Joe Pa­pa, he now wants to take this new com­pa­ny all the way through to com­mer­cial­iza­tion. And Pa­pa has joined his board at Prometheus, watch­ing the work from a front-row seat.

It was Prometheus chair­man Tachi Ya­ma­da, a leg­end in the biotech busi­ness, who reached out to McKen­na to see if he would be in­ter­est­ed in run­ning Prometheus, af­ter watch­ing his work at Sal­ix.

Ya­ma­da, no doubt, al­so played a role in bring­ing to­geth­er a large syn­di­cate of in­vestors.

Even­tide As­set Man­age­ment and RTW In­vest­ments led the round with a slate of new in­vestors: Per­cep­tive Ad­vi­sors, Cor­morant Cap­i­tal, Cowen Health­care In­vest­ments, Point72 As­set man­age­ment and Irv­ing In­vestors. Then there are the ex­ist­ing in­vestors: As­cend Glob­al In­vest­ment Fund, Cedars-Sinai Med­ical Cen­ter and Nestlé SA. Joy Ghosh of Even­tide As­set Man­age­ment and Adam Stone of Per­cep­tive Ad­vi­sors will be join­ing the Prometheus board to watch over their in­vest­ments.

They’re back­ing a com­pa­ny that has grown to 125 staffers, in a mar­ket that might sug­gest they’re think­ing about an IPO.

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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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.

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.

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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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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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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