Temasek leads $85M round for Chi­nese biotech aim­ing for cheap­er, faster, bet­ter CAR-T ther­a­pies

The land­mark ap­provals of CAR-T ther­a­pies have been her­ald­ed, but emerg­ing sup­ply chain hur­dles cat­alyzed by the com­plex man­u­fac­tur­ing process for the cel­lu­lar ther­a­pies have pushed mak­ers to look for ways to stream­line and quick­en the process to aug­ment prod­uct vol­umes and shore up adop­tion. Chi­na’s Gra­cell is look­ing to cap­i­tal­ize on these tech­ni­cal wob­bles, with its crop of new, low cost cell ther­a­pies, with the back­ing of sto­ried in­vestor Temasek.

On Mon­day, Gra­cell said it had scored $85 mil­lion in Se­ries B fund­ing, led by Temasek and fea­tur­ing par­tic­i­pa­tion from Lil­ly Asia Ven­tures, King­ton Cap­i­tal, King Star Cap­i­tal and Cheng­du Miao­ji, to shep­herd its pre­clin­i­cal CAR-T prod­ucts in­to hu­man tri­als.

Wei (William) Cao

The com­pa­ny was es­tab­lished in 2017 by Wei (William) Cao — who pre­vi­ous­ly found­ed and led Cel­lu­lar Bio­med­i­cine Group $CB­MG — and was ini­tial­ly sup­port­ed by 6 Di­men­sions in a Se­ries A round soon af­ter the Suzhou-based firm’s for­ma­tion. 

“Im­mune cell gene ther­a­py is ex­pect­ed to be­come a pil­lar of mod­ern med­i­cine, but the in­dus­try is still in its in­fan­cy. Chal­lenges and op­por­tu­ni­ties co­ex­ist,” Cao said in a state­ment.

Gra­cell is itch­ing to al­le­vi­ate some of these con­straints: high pro­duc­tion costs, lengthy man­u­fac­tur­ing process, a pauci­ty of off-the-shelf prod­ucts and a short du­ra­tion of ther­a­peu­tic ef­fects, with its raft of ear­ly-stage CAR-T prod­ucts. The no­tion is com­mend­able, but there is a long road ahead.

Cell ther­a­py man­u­fac­tur­ing is con­vo­lut­ed. Es­sen­tial­ly, the jour­ney be­gins with the col­lec­tion of cells from the pa­tient (with their spe­cif­ic ge­net­ic back­ground and med­ical his­to­ry) and ends with the ad­min­is­tra­tion of the ther­a­py to the same pa­tient — but in be­tween there are var­i­ous process­es that must take place be­fore these cells are turned in­to a ther­a­peu­tic, un­like a sim­ple off-the-shelf tra­di­tion­al chem­i­cal drug.

These man­u­fac­tur­ing chal­lenges are the pri­ma­ry rea­son be­hind the tepid sales of No­var­tis’ $NVS CAR-T Kym­ri­ah — in the fourth quar­ter, the drug gen­er­at­ed a pal­try $28 mil­lion. How­ev­er, the Swiss drug­mak­er is do­ing its best to shore up man­u­fac­tur­ing, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure.

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.

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.

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.