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.

BREAK­ING: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

AbbVie $ABBV has agreed to pay $188.24 a share — cash and stock — for the troubled Allergan, reflecting a 45% premium as investors bid up shares in anticipation of a much buzzed about company split. That price — with each share of Allergan worth 0.8660 AbbVie shares and $120.30 in cash — reflects a sharp fall from the $330 peak for Allergan and Saunders 4 years ago — but much better than anything shareholders had in mind for the near future.

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UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.