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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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