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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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