Adaptimmune announces 'positive' safety data from pilot studies
Adaptimmune Therapeutics announced initial safety data from its two ongoing pilot studies of SPEAR T-cells targeting MAGE-A10, one in non-small cell lung cancer, or NSCLC, and a triple tumor study in bladder, melanoma, and head & neck cancers. To date, 8 patients have each received 100 million transduced MAGE-A10 SPEAR T-cells in the first dose cohorts of both studies. No evidence of toxicity related to off-target binding or alloreactivity has been observed. There have been no reports of neurotoxicity safety events similar to CAR-T cell-related encephalopathy syndrome, or CRES. In the NSCLC study, there has been one serious adverse event of cytokine release syndrome, or CRS, a Grade 4 event that resolved with treatment. This event led to cohort 1 expansion from 3 to 6 patients. No dose limiting toxicities were observed in cohort 1 of the triple tumor study. Following review by the independent safety review committee, or SRC, the decision has been made to escalate to the next dose of 1 billion transduced MAGE-A10 SPEAR T-cells in the triple tumor study. This was the therapeutic threshold dose observed with SPEAR T-cells targeting NY-ESO in the synovial sarcoma pilot study. The decision to escalate in the NSCLC cohort will be reviewed by the SRC following dosing of the 6th patient.