Ready to ex­pand, Gen­Script rais­es $224M for CD­MO fo­cused on an­ti­bod­ies, cell and gene ther­a­pies

Chi­na’s Gen­Script has brought in new in­vestors to back its bi­o­log­ics-fo­cused sub­sidiary — to the tune of $224 mil­lion.

Gen­Script, which is list­ed in Hong Kong, dis­closed the Se­ries C for Gen­Script Pro­Bio in a fil­ing. The new funds will help “build up man­u­fac­tur­ing ca­pac­i­ty, fur­ther re­search and de­vel­op­ment ca­pa­bil­i­ties and op­por­tunis­ti­cal­ly ac­quire as­sets” to de­vel­op Pro­Bio’s con­tract de­vel­op­ment and man­u­fac­tur­ing busi­ness, the moth­er com­pa­ny wrote.

This marks Gen­Script Pro­Bio’s third fi­nanc­ing round in less than two years. Hill­house Cap­i­tal com­mit­ted $150 mil­lion in June 2021 for the Se­ries A, and oth­er in­vestors came on board for a $37 mil­lion Se­ries B just a year lat­er.

While Gen­Script made its name as a provider of drug dis­cov­ery and de­vel­op­ment ser­vices, it is al­so known as the com­pa­ny that cre­at­ed Leg­end Biotech, the dark­horse play­er whose BC­MA-tar­get­ed CAR-T at­tract­ed a top-dol­lar part­ner­ship with J&J. Leg­end was even­tu­al­ly spun out and found its own place on Nas­daq, and the FDA ap­proved its CAR-T last year.

Back in 2019, the unit that would be­come Pro­Bio teamed up with Leg­end Biotech to con­struct a com­mer­cial man­u­fac­tur­ing cen­ter in Zhen­jiang, Chi­na, that could pro­duce plas­mids and virus­es for cell and gene ther­a­pies. Gen­Script un­veiled the Pro­Bio brand lat­er in the sum­mer of 2020.

It’s since signed on mul­ti­ple cus­tomers, in­clud­ing the deep-pock­et­ed mR­NA con­tender Abo­gen, which want­ed its help mak­ing Covid-19 vac­cines. Pro­Bio al­so of­fers ser­vices in an­ti­body dis­cov­ery and en­gi­neer­ing.

Sto­ried VC and pri­vate eq­ui­ty firm Leg­end Cap­i­tal (un­re­lat­ed to Leg­end Biotech) led the round. Oth­er in­vestors in­clude Zhuhai Fen­heng En­ter­prise Man­age­ment Con­sult­ing Cen­ter, HLC VGC and Shang­hai Lian­peng En­ter­prise Man­age­ment Part­ner­ship.

Fol­low­ing the close, Gen­Script’s stake in Pro­Bio drops from around 80% to about 70%.

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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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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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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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.