RARE Daily

Adaptimmune to Cut 25 to 30 Percent of Staff as it Prepares BLA for Rare Cancer

November 9, 2022

Rare Daily Staff

Cell therapy focused Adaptimmune Therapeutics said it is de-prioritizing non-core programs and cutting its workforce by 25 to 30 percent in order to preserve resources and focus on submitting a Biologics License Application to the U.S. Food and Drug Administration for its autologous cell therapy for the treatment of the rare cancer synovial sarcoma, the first indication for lead candidate afami-cel.

“We are seeing the positive impact that our therapies can have on people with cancer with afami-cel and unprecedented data with our next-gen T-cell therapy in the SURPASS trial,” said Adrian Rawcliffe, CEO at Adaptimmune. “We now have full control of our T-cell program directed to PRAME, an equally important T-cell target in solid tumors. It is evident that we need to focus on developing these two programs which have immense therapeutic potential. We have taken decisive action to deprioritize non-core programs and made the difficult decision to restructure to extend our cash runway into early 2025.”

The company reported the news in its third quarter 2022 financial report, in which it also said it would be changing the cell line being used to develop its MAGE-A4 allogeneic cell therapy due to the presence of a chromosomal abnormality in the original cell line. This change will delay the timing of the first allogeneic IND submission to 2025.

Synovial sarcoma is a rare and aggressive soft tissue sarcoma. It is often found in the arm, leg, or foot, and near joints such as the wrist or ankle. Afami-cel (afamitresgene autoleucel) is an autologous, genetically engineered cell therapy directed to a member of the MAGE family of cancer testis antigens expressed in a number of solid tumor cell types. The MAGE- A4 antigen is among the most commonly expressed cancer testis antigens.

Adaptimmune said it had a productive pre-BLA meeting with the FDA on October 13th in which the FDA agreed that Adaptimmune’s clinical package for afami-cel supports submission of the BLA for the proposed indication for the treatment of synovial sarcoma. The agency and the company reached agreement on the overall content of the BLA submission and Adaptimmune plans to initiate the rolling submission in the fourth quarter of this year with target for completion in mid-year 2023. Afami-cell has RMAT status for synovial sarcoma, and thus is eligible for priority review by the FDA.

Positive and confirmatory data from Cohort 1 of the registrational SPEARHEAD-1 trial will be presented at the Connective Tissue Oncology Society annual meeting on November 18th.

Adaptimmune said data continue to indicate that afami-cel is efficacious in heavily pre-treated patients with synovial sarcoma with an overall response rate of 38.6 percent by independent review. Responses are durable with a median duration of 50.3 weeks. The safety profile includes cytokine release syndrome and reversible hematologic toxicities, in line with previous findings indicating an acceptable benefit to risk profile. Translational data indicate that afami-cel drives tumor infiltration of activated and proliferative cytotoxic (“killer”) T-cells, shifting the balance in the tumor from immuno-suppressive to pro-immune and aiding in clinical response.

Photo: Adrian Rawcliffe, CEO at Adaptimmune

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