BioNTech Announces Publication of Preclinical Data for first-in-kind CAR-T Cell Therapy Approach Targeting Solid Tumors in Science

On January 2, 2020 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported a publication in Science on the company’s novel CAR-T therapeutic approach for solid tumors which utilizes a CAR-T Cell Amplifying RNA Vaccine, or CARVac (Press release, BioNTech, JAN 2, 2020, View Source [SID1234552654]). The report entitled "An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors" provides preclinical proof-of-concept data for BioNTech’s first CAR-T product candidate BNT211, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6), and outlines CARVac as a broadly applicable RNA vaccine approach to improve therapeutic efficacy of CAR-T cell therapies.

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Although CAR-T cell therapy has shown significant clinical efficacy in blood cancers, it still faces major challenges in solid tumors, including a limited number of identified cancer-specific solid tumor targets, inefficient infiltration of CAR-T cells into solid tumors and insufficient CAR-T cell persistence. BioNTech aims to overcome these hurdles by targeting CLDN6, a novel tumor specific antigen expressed in multiple solid tumors, in combination with an RNA vaccine promoting the amplification and persistence and efficacy of CAR-T cells in vivo.

In the published study, a second generation CLDN6-CAR-T therapy with a 4-1BB costimulatory domain (BNT211) was evaluated both in vitro in tumor cell lines and in vivo in mice with human ovarian cancer transplants. In mice, CLDN6-CAR-T cell therapy demonstrated complete tumor regression of transplanted large human tumors within two weeks after treatment initiation. Furthermore, the combination with CARVac achieved improved engraftment, proliferation and expansion of CAR-T cells in vivo, resulting in tumor regression even at sub-therapeutic CAR-T doses. CARVac was also successfully applied for CAR-T cells targeting the pan-cancer antigen CLDN18.2 and CD19, the target of approved CAR-T cell therapies. The combination of CAR-T cell therapy with CARVac underlines the value of cross-platform synergies to address key development challenges in the treatment of cancer.

BioNTech intends to initiate a first-in-human Phase 1/2 clinical trial for BNT211 this year in solid tumors, including ovarian, testicular, uterine and lung cancer. Manufacturing to support clinical trials of BNT211 will be conducted in-house at BioNTech’s state-of-the-art GMP certified cell therapy manufacturing

facility in Idar-Oberstein, Germany, which has been in operation since 1999. BioNTech initiated a multi-year capacity expansion at the facility in 2018 which it expects to complete in 2020.