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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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FDA ap­provals roundup: Zo­genix's Fin­tepla, Ul­tragenyx's Do­jolvi, and Genen­tech's Ph­es­go

A weekly update on new drug approvals and indications from the FDA:

New approvals

Fintepla gets the go-ahead for Dravet syndrome

Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.

The approval was based on findings from two clinical studies in 202 participants aged between 2 and 18 years, in which the change from baseline in frequency of convulsive seizures was measured. In both studies, children who received Fintepla had significantly greater reductions in the frequency of convulsive seizures, compared with those receiving placebo. The reductions were seen within 3-4 weeks of therapy initiation and remained generally consistent during the treatment periods of 14-15 weeks.