RE: smile11 Apr 2022 11:36
BioNTech Presents Positive Preliminary Phase 1/2 Data for First-in-Class CAR-T Program BNT211 at AACR
2022-04-11 03:55 ET - News Release
BNT211 combines two innovative approaches in one regimen, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells
Treatment with BNT211 alone or in combination with CARVac, currently being tested in a Phase 1/2 Trial in patients with advanced solid tumors, was well tolerated across multiple tumor indications in preliminary data from 16 patients
Preliminary efficacy data showed encouraging signs of clinical activity with a disease control rate of 86% and an overall response rate of 43%
MAINZ, Germany, April 11, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company's novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. The preliminary results demonstrated an encouraging safety profile and anti-tumor activity in testicular cancer patients at the first evaluated dose levels of BNT211. The data were presented in the Clinical Trials Plenary Session at the AACR Annual Meeting 2022 by Prof. John Haanen, M.D., Ph.D., Netherlands Cancer Institute (NKI), Amsterdam, Netherlands.
BNT211 is a potential first-in-class therapeutic approach which comprises two drug products, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac), which is based on BioNTech's mRNA-lipoplex technology to improve persistence and functionality of the adoptively transferred cells.
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. Tumor indications included testicular cancer (n=8) ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. 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; cytokine release syndromes of grade 1 and 2 and one transient occurrence of neurotoxicity grade 1 were observed.
At the first efficacy assessment 6 weeks post infusion, 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. Responses were seen in testicular (n=4) and ovarian cancer (n=2) patients. At