On 24 October 2023, BioNtech announced the preliminary results of phase I/II trial evaluating BNT.221-01, a combination of Claudin 6 (CLDN6)-targeted CAR T cell therapy and the mRNA-based CAR T booster CarVac at ESMO conference in Madrid. BioNtech reported acceptable safety and tolerability data and first hints to efficacy in solid tumours. The CAR T cells used for the treatment were produced by an automated process. Following lymphodepletion, CAR T cells were dosed at four dose levels (DLs, 1×106 up to 2-5×108 CAR-T cells) plus ± repeat CLDN6 CARVac dosing (1×50 μg, then 100 μg doses).
It is worth highlighting that 38 patients suffering from ovarian cancer and germ cell tumors were treated as of 25 July 2023. Further, 23 patients (61%) experienced grade 3 and above treatment emergent adverse events (TEAEs), including 20 (53%) with TEAEs related to CAR-T cells. Additionally, 9 of the 21 patients treated with the combination therapy reported TEAEs above grade three related to both drugs, and two (10%) to CARVac. Dose limiting toxicities occurred in two patients from different cohorts, therefore, maximum tolerated dose (MTD) could not be determined. One treatment-related death was reported after the data cut-off. However, cytokine-release syndrome, which generally occurs in patients treated with CAR T cell therapy, was predominantly (95%) grade 1 or 2 and observed in 18 (47%) patients.
According to Roots Analysis, CAR T cell therapy market size is poised to reach USD 25 billion by 2035, growing at a CAGR of 20% from 2022 to 2035.
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