FDA Approves Adaptimmune Therapeutics' Engineered Cell Therapy As First For Solid Tumor And New Therapy For Rare Soft Tissue Cancer In Over A Decade

Thursday, the FDA approved Adaptimmune Therapeutics plc’s ADAP Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma, a rare type of cancer that tends to occur near large joints, mainly the knees.

The approval covers patients who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen.

This indication is approved under accelerated approval based on the overall response rate and duration of response.

Tecelra is the first engineered cell therapy for a solid tumor cancer approved in the U.S. and the first new therapy option in more than a decade for synovial sarcoma.

Tecelra’s approval was based on the SPEARHEAD-1 (Cohort 1) trial results, which included 44 patients.

Tecelra treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was six months.

Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer.

Adaptimmune plans to have at least six to ten authorized treatment centers (ATCs) up and running this year and to onboard approximately 30 treatment centers within the first two years.

“TECELRA (afami-cel), which uses each patient’s own immune cells to recognize and attack their cancer cells in a one-time infusion treatment, is significantly different than the current standards of care for advanced synovial sarcoma,” said Sandra D’Angelo, SPEARHEAD Trial Principal Investigator.

In May, Galapagos NV GLPG and Adaptimmune Therapeutics entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ decentralized cell manufacturing platform.

Adaptimmune to receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales.

Price Action: ADAP stock is up 7.09% at $1.36 during the premarket session at last check Friday.

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