Kite lines up a JV in Chi­na while Dai­ichi Sankyo strikes $250M-plus deal to launch CAR-T drug in Japan

He­len Kim, Kite

With its new drug ap­pli­ca­tion for the pi­o­neer­ing CAR-T drug KTE-C19 in the fi­nal weeks from be­ing com­plet­ed and shipped to reg­u­la­tors in search of an ac­cel­er­at­ed ap­proval, Kite Phar­ma $KITE has now lined up two part­ners to man­age their prospec­tive leap in­to two key Asian mar­kets. Kite has pulled the wraps off a joint ven­ture for Chi­na while ink­ing a $250 mil­lion-plus deal to break in­to the Japan­ese mar­ket along­side Dai­ichi Sankyo.

Kite is tak­ing a $50 mil­lion up­front and $200 mil­lion in mile­stones for the Japan­ese deal, while Dai­ichi Sankyo is re­serv­ing an­oth­er $200 mil­lion in ad­di­tion­al mile­stones for each new drug can­di­date that Kite takes to the FDA over the next three years. Roy­al­ties will range from the low to mid-dou­ble dig­it range.

The biotech has com­plet­ed a deal to cre­ate a JV in Chi­na with Fo­s­un Phar­ma, which is hand­ing over $40 mil­lion up­front, $20 mil­lion for ini­tial fund­ing for clin­i­cal ac­tiv­i­ties and man­u­fac­tur­ing and a set of mile­stone pay­ments for their CAR-T in a 50/50 deal.

The deal for Japan part­ners Kite with one of the biggest play­ers in that coun­try’s phar­ma in­dus­try, and one that is com­mit­ted to build­ing up the in­fra­struc­ture to pro­duce and mar­ket these in­di­vid­u­al­ly tai­lored ther­a­pies, which ex­tract T cells from pa­tients and en­gi­neer them in­to at­tack weapons point­ed at can­cer cells.

“Dai­ichi Sankyo made a strate­gic de­ci­sion to get in­to cell ther­a­py,” says He­len Kim, Kite’s chief of busi­ness de­vel­op­ment. “The struc­ture is a more tra­di­tion­al li­cens­ing agree­ment. We will pro­vide tech­nol­o­gy trans­fer on the man­u­fac­tur­ing. It’s their de­sire to do the man­u­fac­tur­ing” in Japan.

“They’re very strong in on­col­o­gy,” she added about Fo­s­un. “They just have a huge pres­ence” in Chi­na.

Kite’s been en­gaged in a race with No­var­tis for the first ap­proval for a CAR-T ther­a­py, while one-time ri­val Juno strug­gles with a lead pro­gram which has been linked to five pa­tient deaths due to brain tox­i­c­i­ty. These first CAR-Ts have been as­so­ci­at­ed with cy­tokine re­lease syn­drome, but have al­so shown great promise in treat­ing ag­gres­sive non-Hodgkin lym­phoma, where Kite has been tar­get­ing its first ap­proval.

Kite has a Eu­ro­pean sub­sidiary that plans to wres­tle for an ap­proval on the con­ti­nent.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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