BioNTech presents Phase 1/2 data update for BNT211 in advanced solid tumors

BioNTech announced follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company’s Claudin-6-directed CAR-T cell therapy candidate BNT211 in patients with CLDN6-positive refractory/relapsed solid tumors. The data show encouraging signs of clinical activity and an increased persistence of cancer-specific CAR-T cells when combined with CARVac. At the ESMO Congress 2023 in Madrid, Prof. John Haanen, M.D., Ph.D., Netherlands Cancer Institute, Amsterdam, Netherlands presented the data in an oral late-breaking data session which confirms the positive interim data presented at this year’s American Society of Clinical Oncology Annual Meeting in Chicago, USA. The data update included 44 patients who received CLDN6 CAR-T cells at four dose levels alone or in combination with CARVac. Patients with germ cell tumors, ovarian cancer and other solid tumor types were treated. In course of the dose escalation, a dose-dependent increase in adverse events was observed, with cytokine release syndromes occurring in 23 of 44 safety evaluable patients. In most cases, these were of grade 1 and 2, with one patient with a grade 3 and one with a grade 4 event. Neurotoxicity was mild and self-limiting in two patients. Of the total 44 patients, 38 were efficacy evaluable. The overall response rate for these 38 patients was 45% and the disease control rate 74%. Further, 27 patients were treated with CLDN6 CAR-T cells at dose level 2 with or without CARVac. At this dose level, 13 patients showed partial responses resulting in an ORR of 59% and a DCR of 95%. Additionally, in the same cohort, patients who received CARVac showed a prolonged persistence of CAR-T cells. These results further underline the potential of BioNTech’s BNT211 program. One objective of the ongoing Phase 1/2 trial is to determine the recommended dose for the initiation of a potential pivotal Phase 2 trial in patients with germ cell tumors which is expected to be initiated in 2024.