- BioNTech SE (NASDAQ: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.
