Sil­i­con Val­ley celebs chip in­to $250M round for age-fight­ing start­up Celu­lar­i­ty. Pla­cen­ta-based CAR-Ts on the hori­zon?

A star-stud­ded Cel­gene spin­out is step­ping out to­day with $250 mil­lion in fresh cash to de­vel­op its quick­ly ma­tur­ing stem cell plat­form to treat can­cer, au­toim­mune dis­or­ders, and ul­ti­mate­ly to de­lay the ag­ing process.

Robert Hariri

The com­pa­ny, called Celu­lar­i­ty, is a New Jer­sey-based start­up co-found­ed by X-Prize founder Pe­ter Dia­man­dis and ex-Cel­gene ex­ec­u­tive Bob Hariri. You might al­so know these guys as the co-founders of Hu­man Longevi­ty, an­oth­er age-fight­ing start­up that scored a sim­i­lar­ly huge round of start­up cash back in 2016.

Celu­lar­i­ty is chock full of big names in both biotech and tech, with a board that in­cludes for­mer Ap­ple CEO John Scul­ley, GV (for­mer­ly Google Ven­tures) founder and Sec­tion 32 cre­ator Bill Maris, and ex-FDA com­mis­sion­er An­drew Von Es­chen­bach.

Pe­ter Dia­man­dis

Al­though brand new, the com­pa­ny is not com­plete­ly green. The com­pa­ny’s tech has been built up at Cel­gene over the past decade. The phar­ma gi­ant went through a se­ries of ac­qui­si­tions years ago when pla­cen­tal cells were be­ing hyped as a so­cial­ly ac­cept­able al­ter­na­tive to em­bry­on­ic stem cells. All these years lat­er, that tech was spun out in­to Celu­lar­i­ty, a com­pa­ny that launched last sum­mer with 200 is­sued and pend­ing patents, pre­clin­i­cal and clin­i­cal as­sets, and com­mer­cial prod­ucts ac­quired from Cel­gene, Sor­ren­to, Unit­ed Ther­a­peu­tics, and Hu­man Longevi­ty.

“Celu­lar­i­ty was formed as a new biotech­nol­o­gy mod­el de­signed to ap­ply the nec­es­sary ex­per­tise to har­ness our pla­cen­ta dis­cov­ery plat­form across a range of un­met med­ical needs,” Hariri said in a state­ment at the time.

One ap­pli­ca­tion for the com­pa­ny’s busi­ness has biotech par­tic­u­lar­ly in­trigued. The com­pa­ny says it plans to build CAR-T ther­a­pies us­ing pla­cen­tal cells, not a pa­tient’s own T-cells, which, in the­o­ry, will cre­ate stan­dard­ized prod­uct that won’t cause the pa­tient’s im­mune sys­tem to flare in protest. Celu­lar­i­ty will ask the FDA to start tri­als on a CAR-T tar­get­ing a pro­tein called CD38, and says it’s li­censed 50 oth­er po­ten­tial CAR-T con­structs from Sor­ren­to.

The com­pa­ny is al­so work­ing on treat­ments for wound heal­ing and rheuma­toid arthri­tis, as well as cell ther­a­py can­di­dates.

“The ob­jec­tive is to make 100 years of age an ex­treme­ly achiev­able goal for peo­ple, but to al­low their bi­o­log­ic func­tion­al­i­ty to work like it did when they were decades younger,” Hariri told CNET.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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A long­time Pfiz­er chief's ul­tra-qui­et biotech re-emerges with new cash and plans for the clin­ic

In August 2018, a tiny biotech spinout from Cornell announced they had hired former high-ranking Pfizer executive Geno Germano as CEO. And then they said nothing else. For two years. Literally, the company, called Elucida Oncology, did not issue a single other press release until this past October, when they hired a chief medical officer.

Now, though, Elucida seems to be ready to start taking the lid off their operations. On Tuesday at JP Morgan, Germano walked investors through the nanoparticle technology they’ve been developing for cancer. And the same day, the company announced a new financing, raising $44 million in a Series “A-1” round meant to propel them into the clinic this year.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.