BioNTech to Present Clinical Updates for Next-Gen Immunotherapies at ASCO 2024

MAINZ, Germany, May 21, 2024 – BioNTech SE is set to unveil notable clinical trial data from its wide-ranging immuno-oncology pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, taking place from May 31 to June 4, 2024. This presentation will include updates on the company's CAR-T cell and individualized mRNA programs, backed by data from two observational studies in patient groups targeted by these therapies.

According to Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech, the company’s mission is to innovate cancer treatment across all stages of the disease. The data being presented aims to inform further development of key product candidates and optimize the design of upcoming pivotal and later-stage clinical trials, covering areas like novel immunomodulators, cell therapies, and mRNA-based cancer vaccines.

Key highlights from BioNTech’s presentations at ASCO 2024 include:

1. BNT327/PM8002 Trials: Updated data from several Phase 1b/2a trials of BNT327/PM8002, a bispecific antibody targeting PD-L1 and VEGF-A for solid tumors, will be shared. This antibody aims to normalize tumor blood vessels and stimulate immune response. The updates will cover advanced cervical cancer, platinum-resistant recurrent ovarian cancer, and non-small cell lung cancer (NSCLC). This product is in development with Biotheus Inc.

2. BNT311/GEN1046 (acasunlimab) Study: Initial results from a Phase 2 trial of BNT311/GEN1046, a bispecific antibody combining PD-L1 inhibition with 4-1BB activation, will be disclosed. This study involves patients with previously treated metastatic NSCLC and is conducted in collaboration with Genmab S/A.

3. Epidemiological Data on Colorectal Cancer: BioNTech will present preliminary findings from an epidemiological study linking post-operative circulating tumor DNA (ctDNA) levels with disease-free survival in colorectal cancer patients. This data supports an ongoing Phase 2 trial of the individualized neoantigen-specific immunotherapy (iNeST) candidate autogene cevumeran (BNT122) for high-risk stage II/III colorectal cancer. This candidate is co-developed with Genentech Inc.

4. Real-World Data on Testicular Germ Cell Tumors: An analysis of real-world data on testicular germ cell tumor patients undergoing palliative chemotherapy will be presented. This research will guide the design of a pivotal trial for the CAR-T cell therapy candidate BNT211, which targets the oncofetal antigen Claudin-6 (CLDN6) and includes an investigational RNA vaccine (CARVac) to amplify CAR-T cells.

BioNTech has constructed a diverse oncology pipeline utilizing a modular multi-platform approach, advancing over 20 clinical programs for various unmet needs in solid tumors. These include mRNA-based therapies, cell therapies, antibody-drug conjugates, and novel immunomodulators. Currently, more than 30 clinical studies are ongoing, with nine programs in advanced Phase 2 trials and two in pivotal Phase 3 trials. BioNTech aims to initiate ten or more potentially registrational trials by the end of 2024, with the goal of launching its first cancer immunotherapy in 2026 and achieving approvals for ten cancer indications by 2030.

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