Faster, cheap­er, bet­ter? Post-buy­out deal Cel­gene jumps in­to AI al­liance with a $25 mil­lion bet on speed­ing dis­cov­ery work

Cel­gene clear­ly isn’t wait­ing in lim­bo to see when, or if, the big Bris­tol-My­ers Squibb deal will go through. It’s still ex­e­cut­ing deals, and the R&D side of the busi­ness has just en­list­ed one of the more promi­nent AI play­ers to go to work on a trio of new drug projects in on­col­o­gy and im­munol­o­gy. They’re pay­ing $25 mil­lion up front to get the tech par­ty start­ed.

An­drew Hop­kins

Cel­gene, a top 15 R&D group world­wide by re­search bud­get, tied up with Ex­sci­en­tia in Ox­ford, UK for the work. We aren’t get­ting any specifics about the tar­gets, but the com­pa­ny is ex­plor­ing AI to see how it lives up to the emerg­ing field’s big boast: That they can de­liv­er new drugs for hu­man test­ing faster and more ac­cu­rate­ly than the stan­dard in­dus­try ap­proach the big play­ers have been us­ing. In Cel­gene’s case, that would com­mon­ly mean go­ing out and do­ing a dis­cov­ery deal with a biotech, but the ma­jors al­so have their own in-house op­er­a­tions.

“This is the largest AI deal so far,” Ex­sci­en­tia CEO An­drew Hop­kins tells me, with “very sub­stan­tial” mile­stones built in.

The AI play­er’s boast is that they can take you through con­cept to hit dis­cov­ery and lead iden­ti­fi­ca­tion in 12 months or less — which they say they’ve done 4 times now. The first 3 were bis­pecifics, not easy to do, the CEO adds.

It’s an in­ter­est­ing busi­ness mod­el which has at­tract­ed con­sid­er­able at­ten­tion over the last 2 years. It’s al­so de­liv­ered pacts for Ex­sci­en­tia with a bevy of promi­nent in­dus­try play­ers: Roche, GSK, Sanofi and Evotec.

Like oth­ers in the field, Hop­kins likes to point to the num­bers in an in­flu­en­tial study that Steven Paul — now a biotech en­tre­pre­neur — did in the spring of 2010 dur­ing a lengthy stint at Eli Lil­ly which un­der­scored the kind of time and mon­ey that a phar­ma gi­ant spent on dis­cov­ery (How to im­prove R&D pro­duc­tiv­i­ty: the phar­ma­ceu­ti­cal in­dus­try’s grand chal­lenge). The cap­i­tal­ized cost of lead op­ti­miza­tion alone, he and his team — which in­clud­ed Bernard Munos — cal­cu­lat­ed, was $414 mil­lion. The out of pock­et for lead op­ti­miza­tion was $146 mil­lion.

These num­bers have been known to cause some hoot­ing in the biotech world, where it’s not un­com­mon to get $30 mil­lion — or con­sid­er­ably less — in VC mon­ey to get through to an IND. Lead op­ti­miza­tion in the biotech world hap­pens less ex­pen­sive­ly. But the ma­jors are play­ing a dif­fer­ent game, which is one rea­son why most of the phar­ma gi­ants have been work­ing on AI as a way to im­prove ef­fi­cien­cies — though many would tell you the ju­ry is out and will re­main out un­til these IND projects turn in­to ap­proved drugs.

One num­ber that Hop­kins was cu­ri­ous­ly un­will­ing to part with was the size of his staff. He de­clined to say how many em­ploy­ees work at the AI com­pa­ny, and a spokesper­son fol­lowed up with “less than 50.” Af­ter this sto­ry post­ed on­line, an­oth­er con­tact came back with “around 50.” So make of that what you will.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.