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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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