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.
Posted In: BriefsPhase 1 TrialBiotechNewsHealth CareGeneral