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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations.