No­var­tis re­search leader takes the helm at Forty Sev­en, a CIRM-backed fledg­ling al­ready deep in the clin­ic

Men­lo Park, CA-based Forty Sev­en launched well ahead of the game com­pared to most any oth­er biotech up­start. When the com­pa­ny was spun out of the lab of Stan­ford’s leg­endary Irv Weiss­man a year ago with a $75 mil­lion Se­ries A from a syn­di­cate in­clud­ing Google’s ven­ture arm, their an­ti-CD47 an­ti­body Hu5F9-G4 was al­ready in a pair of ear­ly-stage tri­als. And last week the com­pa­ny added an im­pres­sive CEO, grab­bing No­var­tis’ head of biosim­i­lar de­vel­op­ment at San­doz, Mark Mc­Camish, for the helm.

Mc­Camish will be lead­ing a team that in­cludes sci­en­tif­ic founders Ravi Ma­jeti, Mark Chao and Jens Volk­mer, who had been work­ing on CD47 at Stan­ford for the six years lead­ing up to the launch — a time that has drawn some scruti­ny for the close ties that ex­ist­ed be­tween Weiss­man and Alan Troun­son, the for­mer head of the Cal­i­for­nia In­sti­tute of Re­gen­er­a­tive Med­i­cine, which has pro­vid­ed more than $40 mil­lion in fund­ing for the ear­ly re­search work on the biotech’s CD47 pro­gram.

“Forty Sev­en has made un­prece­dent­ed progress to date based on the re­mark­able sci­ence ini­ti­at­ed by the world-class ef­forts of Dr. Irv Weiss­man and Dr. Ravi Ma­jeti and their com­bined team at Stan­ford Uni­ver­si­ty. In ad­di­tion, (Abing­worth vet) Jonathan Mac­Quit­ty has as­sem­bled an amaz­ing team at the com­pa­ny,” said Mc­Camish in a state­ment. “Forty Sev­en’s tech­nol­o­gy pro­vides a unique op­por­tu­ni­ty to har­ness the pow­er of the in­nate im­mune sys­tem to help pa­tients de­feat their own can­cer.”

And now Hu5F9-G4 is in 4 stud­ies in the US and the UK in pa­tients with sol­id tu­mors or cu­ta­neous T-cell lym­phoma, acute myeloid leukemia, non-Hodgkin’s lym­phoma and col­orec­tal car­ci­no­ma.

CD47 scram­bles a key im­mune re­sponse that helps guard a range of tu­mor types by pre­vent­ing a process called phago­cy­to­sis, in which the can­cer cells are de­voured by a phago­cyte. That’s what the re­searchers call a “don’t eat me” ef­fect. The treat­ment al­so promis­es to whip up a T-cell at­tack on can­cer, fit­ting in to a range of im­muno-on­col­o­gy pro­grams.

Forty Sev­en is where it is to­day be­cause of Weiss­man’s re­mark­ably close re­la­tion­ship with the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine, a tax­pay­er sup­port­ed group that set out to fire up a rev­o­lu­tion in the use of stem cells to fight dis­ease.

Back in 2009, Weiss­man scored a $20 mil­lion grant for his work on CD47 with four years of fund­ing for his pre­clin­i­cal re­search on AML.  An­oth­er $12.7 mil­lion ar­rived in 2013, her­ald­ed by CIRM’s Troun­son — who took over the agency in 2007 — as “the sharp end of the CIRM pro­gram – we need to get ther­a­pies in­to clin­i­cal tri­als.”

A week af­ter Troun­son left the helm of CIRM in 2014, af­ter CIRM had pro­vid­ed more than $30 mil­lion in sup­port to Weiss­man’s CD47 work, he wound up side by side with Weiss­man on the board of Stem­Cells, which the Stan­ford pro­fes­sor had al­so found­ed, and which CIRM had pro­vid­ed mil­lions in grants.

In 2015, Troun­son would get $100,000 in com­pen­sa­tion from Stem­Cells, ac­cord­ing to an SEC fil­ing. The year be­fore, it was $343,000 — sev­er­al times more than any oth­er di­rec­tor — for on­ly part of the year. Stem­Cells foundered, like many oth­er stem cell ven­tures, and was lat­er tak­en over, wip­ing out any val­ue from CIRM’s in­vest­ment.

Those ties be­tween Weiss­man and Troun­son stirred up a small scan­dal at the time, al­most en­tire­ly be­cause of the Stem­Cells com­pen­sa­tion, with the on­line Cal­i­for­nia Stem Cell Re­port tak­ing the lead.

Not much at­ten­tion, though, has been paid to Troun­son’s sup­port for Weiss­man’s oth­er com­pa­ny in the mak­ing. CIRM, though, con­tin­ues to be a big sup­port­er well af­ter Troun­son’s de­par­ture. Even af­ter the big A round CIRM came in with an­oth­er grant. Af­ter com­ing up with a new strat­e­gy to back clin­i­cal tri­als, fol­low­ing years of crit­i­cism that noth­ing much was com­ing from bil­lions in new tax­pay­er backed in­vest­ments, CIRM came up with a new slate of in­vest­ments.

Forty Sev­en was first in line, get­ting a $10.2 mil­lion grant.

Mc­Camish, the lat­est in a long line of No­var­tis ex­ecs to leave the com­pa­ny, takes over one of the best fi­nanced biotechs in the Bay Area.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.