Juno, WuXi JV in Chi­na score $100M in fresh fund­ing as it sets stage for first CAR-T ap­proval

Chi­na’s on­col­o­gy-fo­cused biotech hub has raised al­ready mil­lions in ven­ture fund­ing and lured pow­er­ful glob­al bio­phar­ma part­ners to ad­dress the high rates of can­cer in the coun­try. In yet an­oth­er ex­am­ple, the joint ven­ture be­tween Juno and to WuXi’s AppTec has raised a siz­able $100 mil­lion in a fresh round of fund­ing.

The Shang­hai-based com­pa­ny, chris­tened JW Ther­a­peu­tics (an ini­tial each from its root com­pa­nies), was cre­at­ed to mar­ry Juno’s CAR-T de­vel­op­ment ex­pe­ri­ence and WuXi’s AppTec’s mus­cu­lar man­u­fac­tur­ing ca­pac­i­ty. In 2018, it scored $90 mil­lion to take its lead ex­per­i­men­tal B cell ma­lig­nan­cy-fo­cused drug, JW­CAR029, in­to the clin­ic and build a new man­u­fac­tur­ing plant.

Now, as the drug is be­ing ush­ered in­to mid-stage de­vel­op­ment, JW has raised an­oth­er $100 mil­lion in a round led by CPE and Mi­rae As­set, joint­ed by CR-CP Life Sci­ence Fund and Oriza Hold­ings, as well as ex­ist­ing in­vestors in­clud­ing Loy­al Val­ley Cap­i­tal, Temasek, Se­quoia Cap­i­tal Chi­na, ARCH Ven­ture Part­ners. Juno (bought out by Cel­gene, which was swal­lowed by Bris­tol My­ers Squibb) along with WuXi al­so con­tributed.

Apart from Temasek, Se­quoia Cap­i­tal Chi­na, and ARCH Ven­ture Part­ners, the funds will be used to bol­ster the com­pa­ny’s CAR-T pipeline and gear up com­mer­cial­iza­tion ca­pac­i­ty to sup­port po­ten­tial launch­es.

In re­cent years, big US and glob­al drug­mak­ers have al­lied with can­cer biotech com­pa­nies as an en­try point or as a way to ex­pand their foot­print in the pop­u­lous coun­try marred by high rates of can­cer and a bur­geon­ing life sci­ences in­dus­try.

Days ago, Sanofi tied up with Al­pham­ab On­col­o­gy — which made a splashy $230 mil­lion in its pub­lic de­but on the Hong Kong Stock Ex­change (HKEX) late last year — to col­lab­o­rate on a bis­pe­cif­ic an­ti­body fo­cused on treat­ing breast can­cer.

In­novent Bi­o­log­ics, which raised a con­sid­er­able $421 mil­lion in its HKEX de­but in 2018, snagged Roche as a part­ner on Tues­day in a deal that grants it ac­cess to the Swiss drug­mak­er’s bis­pe­cif­ic an­ti­body and CAR-T tech­nol­o­gy. In­novent, in col­lab­o­ra­tion with Eli Lil­ly, was the first drug­mak­er to get a home­grown Chi­nese check­point in­hibitor across the fin­ish line in the coun­try — in late 2018, the PD-1 agent Tyvyt (sin­til­imab) scored ap­proval for pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma. There are a hand­ful of check­point in­hibitors on the Chi­nese mar­ket now, in­clud­ing Jun­shi’s Tuoyi, Mer­ck’s flag­ship Keytru­da and BeiGene’s tislelizum­ab.

BeiGene too has close ties with the Unit­ed States, the world’s largest phar­ma­ceu­ti­cals mar­ket. In ad­di­tion to a cadre of part­ner­ships with small and mid-sized US drug de­vel­op­ers, the com­pa­ny sells a raft of Cel­gene (now Bris­tol My­ers) drugs in Chi­na, while Am­gen has tak­en a hefty 20.5% stake in the drug­mak­er.

Dri­ven part­ly by high rates of pol­lu­tion and smok­ing, can­cer is the lead­ing cause of death in Chi­na. An es­ti­mat­ed 4.3 mil­lion new can­cer cas­es and 2.9 mil­lion new can­cer deaths oc­curred in Chi­na in 2018, ac­cord­ing to a 2019 analy­sis. Com­pared to the USA and UK, Chi­na has low­er can­cer in­ci­dence but a 30% and 40% high­er can­cer mor­tal­i­ty than the two na­tions re­spec­tive­ly, the au­thors found.

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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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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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.