Irv Weissman (Norbert von der Groeben for Stanford)

Stan­ford stem cell pi­o­neer nets $194M from Gilead-Forty Sev­en buy­out

Gilead’s $4.9 bil­lion buy­out of Forty Sev­en, their largest in three years, brought with it a sub­stan­tial wind­fall for the biotech’s founder, CEO and ear­li­est in­vestor.

Chief among those win­ners was Irv Weiss­man, a well-known stem cell pi­o­neer at Stan­ford. Weiss­man and col­league Ravin­dra Ma­jeti found­ed the com­pa­ny out of Stan­ford in 2016, af­ter their ear­ly stud­ies showed that some can­cer cells use CD47 — healthy cells’ “don’t eat me” sig­nal to the im­mune sys­tem — to evade at­tack and that you could treat those can­cers by block­ing the sig­nal.

Ravin­dra Ma­jeti

Weiss­man, who oc­ca­sion­al­ly talks about how his first job in sci­ence paid $25 a month, will earn $194 mil­lion with the deal. Ma­jeti fell a lit­tle short of that, but should be fine with $123 mil­lion.

Weiss­man’s re­mark­ably close re­la­tion­ship with the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine made the ear­ly re­search be­hind Forty Sev­en pos­si­ble. In 2009, CIRM — a gov­ern­ment-sub­si­dized group ded­i­cat­ed to turn­ing stem cell re­search in­to ther­a­pies — gave Weiss­man a $20 mil­lion grant for his CD47 work on AML. An­oth­er $12.7 mil­lion came in 2013. Al­though there was lit­tle ap­par­ent over­lap be­tween re­gen­er­a­tive med­i­cine and CD47, then-CIRM pres­i­dent Alan Troun­son called the grant “the sharp end of the CIRM pro­gram,” adding that “we need to get ther­a­pies in­to clin­i­cal tri­als.”

Alan Troun­son

Troun­son left CIRM in 2013 and then served along­side Weiss­man on the board of Stem­Cells, a biotech al­so found­ed by the pro­fes­sor, where his el­e­vat­ed com­pen­sa­tion caused a mi­nor scan­dal. That com­pa­ny failed, but CIRM’s com­mit­ment to Forty Sev­en con­tin­ued.

Even af­ter Forty Sev­en’s $75 mil­lion Se­ries A in 2016, CIRM gave it a $10.2 mil­lion grant. It was part of a new slate of in­vest­ments the or­ga­ni­za­tion gave out in the wake of crit­i­cism that it had failed to turn bil­lions in tax­pay­er mon­ey in­to ac­tion­able find­ings.

Those grants now look like a good bet: It’s still ear­ly, but the com­pa­ny’s lat­est da­ta showed a com­plete re­sponse rate of 50% and 55% from its lead drug ma­grolimab in myelodys­plas­tic syn­drome and acute myeloid leukemia.

Be­fore the Gilead merg­er, Forty Sev­en said they could file as soon as the end of next year. An ap­proval could be a big win for new Gilead CEO Daniel O’Day. It would al­so give the re­gen­er­a­tive med­i­cine in­sti­tute and the stem cell pi­o­neer one of their biggest ac­com­plish­ments – in a field that has lit­tle to do with re­gen­er­a­tive med­i­cine or stem cells.

Fi­nan­cial­ly, the biggest win­ner be­hind the sci­en­tif­ic co-founders is Sut­ter Hill Ven­tures man­ag­ing di­rec­tor Jef­frey Bird, who will earn $100 mil­lion af­ter the firm co-led the biotech’s Se­ries A, among oth­er in­vest­ments. And CEO Mark Mc­Camish will earn a $105 mil­lion pay­out, a price that should more than jus­ti­fy his de­ci­sion to leave his top-lev­el ex­ec­u­tive role at San­doz to lead the young biotech.

CFO Ann Rhodes will earn $26 mil­lion and CBO Craig Gibbs takes $37 mil­lion.

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.

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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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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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.

En­do pays $658M in a fur­ther bet on col­la­gen-based med­i­cines, buy­ing out long­time bio­phar­ma part­ner

A little less than two years after Endo Pharmaceuticals’ deal to purchase Somerset Therapeutics fell through, the Irish drugmaker is returning to the well with a much bigger acquisition.

Endo has agreed to buy BioSpecifics Technologies for a whopping $658 million, the two companies announced Monday, in the culmination of a research agreement signed all the way back in 2004. Endo will purchase all of BioSpecifics’ outstanding stock for about $540 million, valuing the company at $88.50 per share — a 45% premium on the $61.02 share price at which the company closed on Friday.

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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New Dewpoint Therapeutics CEO Ameet Nathwani (Sanofi)

A long-haul biotech with some im­pres­sive back­ers and big goals re­cruits a ma­jor league R&D ex­ec to the helm. What’s next?

A few weeks ago Kite and Allogene founder Arie Belldegrun jumped into the expanded syndicate for a Boston-based biotech called Dewpoint Therapeutics — a Polaris-birthed venture that’s styled itself as a drug development pioneer out to craft a major pipeline.

That round — which also added deep-pocket player ARCH to the list of backers — came up with $77 million for the next step in the long journey toward the clinic, a nice add to the A round that launched the company. Now we hear that Dewpoint has recruited Ameet Nathwani to the executive suite as the new CEO, who’s taking the helm from Polaris managing partner Amir Nashat, who brought the company into existence.

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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.