Armed with cash, Bel­gian iP­SC play­er makes a play for Celyad’s cell ther­a­py man­u­fac­tur­ing site

A Bel­gian cell ther­a­py play­er has net­ted a deal close to home.

Ncar­dia, a Bel­gium-based con­tract re­search com­pa­ny, spun out its cell ther­a­py and man­u­fac­tur­ing arm in April in­to a com­pa­ny called Cel­lis­tic. Now, the spin-out has ac­quired an 11,000-square-foot fa­cil­i­ty in the town of Mont-Saint-Guib­ert, Bel­gium, for the price of €6 mil­lion ($5.9 mil­lion) from Celyad On­col­o­gy. The deal is ex­pect­ed to close in Q2 of this year.

Ste­fan Braam

Ac­cord­ing to Cel­lis­tic CEO Ste­fan Braam in an email to End­points News, the man­u­fac­tur­er is look­ing to make strides in large-scale al­lo­gene­ic cell ther­a­py pro­duc­tion, and ex­pand­ing its GMP ca­pac­i­ty will help move that mis­sion for­ward.

The ac­qui­si­tion will al­so bring Celyad’s 35 work­ers un­der Cel­lis­tic’s wing, with the site even­tu­al­ly pro­duc­ing iP­SC cell ther­a­pies. Ac­cord­ing to Braam, Cel­lis­tic is work­ing to trans­fer the com­pa­ny’s tech­nol­o­gy and man­u­fac­tur­ing plat­forms to the site and is work­ing with the em­ploy­ees to even­tu­al­ly get pro­duc­tion up and run­ning.

“We have been look­ing at op­tions for GMP ca­pac­i­ty for some time, and eval­u­at­ed a num­ber of oth­er ac­qui­si­tions and part­ner­ships. This is an amaz­ing fit for us – close to our cur­rent de­vel­op­ment work on­go­ing in our Gos­selies fa­cil­i­ty, and a team with ex­per­tise in the im­muno-on­col­o­gy and cell ther­a­py pace who knows the process of bring­ing cell ther­a­pies to the clin­ic too,” Braam wrote to End­points.

Ncar­dia al­so has the cash to make these kinds of moves as, last year, the com­pa­ny re­ceived $60 mil­lion in fund­ing from in­vest­ment plat­form Kinic­i­ti to bol­ster its man­u­fac­tur­ing op­er­a­tions.

For Celyad, the deal comes as the com­pa­ny is look­ing at a 54% fall in its share price $CYAD since last year. Al­so, to­ward the be­gin­ning of this year, it had ini­tial­ly placed a pause on its CAR-T ther­a­py tri­al af­ter two pa­tients died, with the FDA hand­ing down a clin­i­cal hold soon af­ter. Reg­u­la­tors even­tu­al­ly lift­ed the hold at the be­gin­ning of Au­gust.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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