Servier cuts ties with Allogene, ending complex CAR-T partnership

Biotech
Thursday, September 22nd, 2022 7:14 am EDT

French drugmaker Servier has terminated a partnership with Allogene, ending a deal whose origins began well before the high-profile developer of “off-the-shelf” cancer cell therapies was formed four years ago.

A regulatory filing on Wednesday by Allogene revealed Servier’s decision to back out of the alliance, which granted Servier partial rights to a group of blood cancer treatments. One of them, a lymphoma treatment called ALLO-501a, is Allogene’s most advanced drug prospect. Development of another, a leukemia drug known as UCART19, hasn’t progressed since early trials were completed in 2020. The deal also granted Servier some rights to any other cell therapies from Allogene that similarly focus on a protein called CD19.

The alliance dates back years before the formation of Allogene and involves Cellectis — another French drug company focused on cell therapies — and pharmaceutical giant Pfizer.

Pfizer and Servier each struck deals with Cellectis in 2014. Both were early bets on so-called allogeneic cell therapy, a more convenient alternative to the personalized CAR-T treatments now on the market for certain blood cancers. Servier’s deal centered around UCART19, a potential therapy for acute lymphoblastic leukemia and chronic lymphocytic leukemia and one of the first “off-the-shelf” cell therapy programs to reach clinical development. Pfizer’s partnership was broader, involving as many as 15 targets.

A year later, all three became partners. Servier acquired full rights to UCART19 and made a side deal with Pfizer to help develop the treatment, with Cellectis eligible for milestones and royalties. That didn’t last long, however. In April 2018, Pfizer spun its cell therapy work, including its alliance with Servier and U.S. rights to UCART19, into Allogene.

Allogene pivoted to the public markets, raising $288 million in an initial public offering six months later and, in its prospectus, touted UCART19 as its top program.

Its priorities have since shifted. Phase 1 studies were presented at a major medical meeting in 2018, after which Servier determined no more patients would be enrolled, filings show. The two were assessing “potential next generation technology” that might improve results in acute lymphoblastic leukemia. In the meantime, they began work on ALLO-501, which is “identical to UCART19 in molecular design,” but involves a different manufacturing process. Allogene later tweaked the product further, leading to ALLO-501a.

ALLO-501a could soon become the first allogeneic cell therapy to reach a registrational trial, as Allogene in August said it expected clearance from U.S. regulators to begin testing “within weeks.” UCART19, meanwhile, is no longer listed in its pipeline.

Baird analyst Jack Allen, citing conversations with Servier, wrote in a research note that the French drugmaker is no longer interested in cell therapy. Its decision now leaves Allogene with the option to acquire non-U.S. rights to ALLO-501a and cover more of the development costs. The original deal with Pfizer has spawned Allogene programs for multiple myeloma, solid tumors, and other cancers.

“In our view, we think there may be some tension between Servier and Cellectis” given the Servier had been “slow-playing development” of the programs internationally, added Stifel analyst Benjamin Burnett, after speaking with Allogene. “We suspect that the relationship between Allogene and Cellectis is likely healthy.”

Allogene shares fell about 11% in trading on Wednesday and slid further Thursday morning. Cellectis shares fell 6% Wednesday and are trading near all-time lows.

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