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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.