Center for Breakthrough Medicines‘ headquarters at the Discovery Labs, King of Prussia, Pennsylvania

Ko­re­an con­glom­er­ate SK takes out stake in cell and gene ther­a­py CD­MO with plans for a ma­jor hir­ing spree out­side Philly

A Penn­syl­va­nia CD­MO spe­cial­iz­ing in cell and gene ther­a­py man­u­fac­tur­ing is re­ceiv­ing a big in­flux of cash from a South Ko­re­an drug­mak­er — and it has plans for a ma­jor hir­ing spree.

SK, the hold­ing com­pa­ny of SK bio­science, will in­vest $350 mil­lion of eq­ui­ty fi­nanc­ing in­to the Cen­ter for Break­through Med­i­cines, with plans to add an ad­di­tion­al 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA fa­cil­i­ty.

CBM will use the funds to add au­toma­tion to its man­u­fac­tur­ing op­er­a­tions from pre-clin­i­cal all the way through com­mer­cial scale. That in­cludes process de­vel­op­ment, vi­ral vec­tor man­u­fac­tur­ing, cell pro­cess­ing, plas­mid DNA and cell bank­ing, it said. The com­pa­ny will bring 700,000 ad­di­tion­al square feet of ca­pac­i­ty on­line and hire staff mem­bers for its site out­side Philadel­phia. The space will be run by The Dis­cov­ery Labs.

Bri­an O’Neill

The deal has been in the works since last Jan­u­ary. It comes eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

CBM was es­tab­lished in 2019. It an­nounced over the sum­mer that it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, South Ko­rea, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

“We chose to part­ner with SK based on our shared deep de­sire to cure can­cer and erad­i­cate ge­net­ic dis­ease,” CBM chair­man Bri­an O’Neill said in a state­ment. “Thou­sands of peo­ple are dy­ing every day, and we have the abil­i­ty to cure pa­tients by man­u­fac­tur­ing these new tech­nolo­gies.

Dong Hoon Lee

The move is a step in the right di­rec­tion for SK Pharmte­co to be­come a top-tier CD­MO by 2025, Dong Hoon Lee, the EVP of SK, said in a state­ment.

In Au­gust, South Ko­re­an Pres­i­dent Moon Jae-in said that he hopes the coun­try can be­come one of the five largest man­u­fac­tur­ing bases in the world by 2025. Moon added biotech man­u­fac­tur­ing to the list of na­tion­al strate­gic tech­nolo­gies along with semi­con­duc­tors and bat­ter­ies and of­fers tax breaks for those com­pa­nies to help pay for ma­te­ri­als, parts and equip­ment.

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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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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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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Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

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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