BioNTech Posts Interim Phase 1 Data From CAR-T/Cancer Vaccine Combo In Solid Tumors

BioNTech SE BNTX presented data from its ongoing Phase 1/2 trial of its CAR-T cell therapy candidate, BNT211, in advanced solid tumors.
The preliminary results demonstrated a favorable safety profile and antitumor activity in testicular cancer patients.
BNT211 comprises an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac).
The presentation included data from 16 patients who received CLDN6 CAR-T cells at dose levels 1 (1x107 CAR-T cells) and 2 (1x108 CAR-T cells) alone or combined with CARVac.
All 16 patients showed robust CAR-T cell expansion 10-17 days after infusion with cell frequencies close to 109 total counts in dose level 2.
Adverse events and dose-limiting toxicities were manageable; mild to moderate cytokine release syndromes and one transient occurrence of mild neurotoxicity was observed.
6 of 14 evaluable patients showed a partial response, and 5 patients had stable disease with shrinkage of target lesions.
One patient showed no change from baseline, and two patients were progressing.
All 4 testicular cancer patients in the higher dose level had disease control, and 3 of these patients showed objective responses.
In addition, 1 testicular cancer patient showed partial response after infusion of the lowest CAR-T dose level combined with CARVac.
4 of 5 patients in the CARVac combination group showed a partial response.
Price Action: BNTX shares are up 0.11% at $170.44 on the last check Monday.

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