Bob Hariri, Celularity CEO (Celularity)

Celu­lar­i­ty emerges from SPAC merg­er dou­bled down on cell ther­a­pies as Bob Hariri down­grades ill-fat­ed Covid-19 pro­gram

It took a few months longer than ex­pect­ed, but Bob Hariri has fi­nal­ly guid­ed Celu­lar­i­ty and its pla­cen­tal-de­rived cells to Wall Street.

Merg­ing with GX Ac­qui­si­tion Corp gives Celu­lar­i­ty $138 mil­lion to work with as Hariri push­es the NK cell and T cell ther­a­pies deep­er in­to ear­ly-stage tri­als.

The biotech, which has drawn at­ten­tion for a high-pro­file ef­fort to test an NK cell in­fu­sion ear­ly in the pan­dem­ic, has all but thrown in the tow­el on Covid-19, pri­or­i­tiz­ing in­stead can­cer in­di­ca­tions such as acute myeloid leukemia and glioblas­toma mul­ti­forme — con­form­ing clos­er to its peers in cell ther­a­py.

“The change in man­age­ment of pa­tients at the hos­pi­tal set­ting made it very very dif­fi­cult to find pa­tients who met the in­clu­sion cri­te­ria,” Hariri told End­points News. “And most pa­tients were be­ing del­e­gat­ed in­to oth­er tri­als.”

While the tri­al was de­signed to en­roll 86 pa­tients with mild to mod­er­ate Covid-19 symp­toms, Celu­lar­i­ty end­ed up giv­ing their NK cell ther­a­py to few­er than 10. Still, Hariri main­tains his team was “very en­cour­aged” by the ear­ly da­ta. They will con­tin­ue to mon­i­tor the pa­tients and pub­lish the da­ta at some point, al­though the CEO didn’t com­mit to a time just yet.

The plan is to re­vis­it vi­ral ill­ness when the op­por­tu­ni­ty aris­es.

Hariri was more ea­ger to talk about da­ta from the AML study in­volv­ing CYNK-001 — in par­tic­u­lar, a sin­gle pa­tient who saw a con­ver­sion from min­i­mal resid­ual dis­ease pos­i­tive to MRD neg­a­tive. More re­sults are com­ing in the fall, he added, while they test the same non-ge­net­i­cal­ly en­gi­neered cells in GBM and a sec­ond, CD19-tar­get­ing CAR-T for B cell ma­lig­nan­cies.

There’s a long way to go in prov­ing the tech­nol­o­gy’s worth, es­pe­cial­ly as the race for cell ther­a­pies that are at once ef­fec­tive, safe, cheap to make and sport a fast turn­around time con­tin­ues to heat up, with mul­ti­ple well-fund­ed star­tups boast­ing that their ap­proach­es — whether au­tol­o­gous or off-the-shelf — would plug any num­ber of the short­com­ings that came with the first gen­er­a­tion of per­son­al­ized CAR-T ther­a­pies.

For Celu­lar­i­ty, the pitch cen­ters on the unique fea­tures of pluripo­tent stem cells found in the pla­cen­ta, which Hariri says is a su­pe­ri­or start­ing ma­te­r­i­al to, say, in­duced pluripo­tent stem cells or adult donor cells that get turned in­to oth­er off-the-shelf prod­ucts be­cause of per­sis­tence and “en­hanced stem­ness.” Then there’s the man­u­fac­tur­ing piece.

“From one pla­cen­ta we can pro­duce hun­dreds of thou­sands of dos­es of pluripo­tent cells, and from one pla­cen­ta we’re cur­rent­ly pro­duc­ing many hun­dreds to thou­sands of dos­es of NK cells,” Hariri said.

He’s al­so hedg­ing his bets by go­ing a dif­fer­ent di­rec­tion in­to Crohn’s dis­ease, where he be­lieves the pla­cen­tal pluripo­tent cells can make good treat­ments for in­flam­ma­tion.

All those clin­i­cal pro­grams have kept the team fair­ly busy, Hariri said, which was a big rea­son why they chose to go pub­lic via the pop­u­lar SPAC path­way — sav­ing them the more oner­ous process of a sep­a­rate crossover round fol­lowed by IPO. The merg­er, which was sched­uled to close in April but got de­layed due to new SEC reg­u­la­tions, of­fi­cial­ly closed Fri­day, paving the way for Celu­lar­i­ty to start trad­ing un­der the tick­er $CELU.

“So we’re gonna ar­rive at where we want­ed to be, and we’ll have cap­i­tal to pros­e­cute our busi­ness plan,” he said.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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