BioNTech to Present Clinical Updates on mRNA and Immunomodulatory Oncology at ESMO 2024

MAINZ, Germany, September 05, 2024 – BioNTech SE has announced it will showcase clinical trial data for various assets from its oncology pipeline at the European Society for Molecular Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17, 2024. The company will present data from several of its clinical programs, including mRNA-based cancer vaccines, next-generation immunomodulators, and targeted therapies.

Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech, stated, "We believe that the future of cancer treatment will be driven by the combination of modalities, including immunomodulators, targeted and mRNA-based therapies." At this year’s ESMO, BioNTech will present data from three clinical trials with BNT327/PM8002, a bispecific antibody that combines PD-L1 checkpoint inhibition with VEGF-A neutralization. This bispecific antibody is being developed in collaboration with Biotheus Inc. and will be a part of multiple novel combination treatment approaches.

Key highlights that will be presented at the ESMO Congress include updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002 in different indications, such as advanced non-small cell lung cancer (NSCLC), locally advanced/metastatic triple-negative breast cancer (TNBC), and advanced renal cell carcinoma. Preliminary data from a Phase 2 trial evaluating BNT113 in combination with PD-1 blockade and data from a Phase 1/2 trial assessing BNT113 as monotherapy in HPV16-driven cancers will also be showcased. These data demonstrate immunogenicity and antitumor activity in heavily pre-treated patients with HPV16-positive indications, including head and neck cancer, and a manageable safety profile.

Moreover, preliminary data from a randomized Phase 2 clinical trial with BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody in combination with pembrolizumab in patients with platinum-resistant recurrent ovarian cancer (PROC), will be featured in a late-breaking session. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc.

In addition, follow-up data from the first-in-human Phase 1 clinical trial with BNT211 will be presented. BNT211 combines autologous CAR-T cells targeting the oncofetal antigen Claudin-6 (CLDN6) and a CAR-T cell amplifying mRNA vaccine (CARVac). The data update reveals signs of antitumor activity across multiple indications and increased persistence of cancer-specific CAR-T cells when combined with CARVac, particularly in patients with testicular and ovarian cancers.

BioNTech has established a diversified clinical oncology pipeline, including mRNA-based therapeutic cancer vaccines, targeted therapies such as cell therapies and antibody-drug conjugates (ADCs), and novel immunomodulators for solid tumors with unmet medical needs. These treatments are currently being evaluated in more than 32 clinical trials globally, including eight programs in advanced Phase 2 trials and two assets in pivotal Phase 3 trials.

BioNTech aims to advance its key programs into late-stage development, targeting to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024.

In summary, BioNTech's presentations at the ESMO Congress 2024 will provide significant updates on its diverse oncology pipeline, highlighting the company's ongoing efforts to advance cancer treatment through innovative therapeutic approaches.