BioNTech to present clinical data updates for oncology candidates

BioNTech will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research Annual Meeting 2024 in San Diego, California, from April 5-10, 2024. The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate approaches. Highlights of BioNTech’s clinical stage programs to be presented at AACR Annual Meeting 2024: Longer-term follow-up data of activity and immune responses of the investigator-initiated first-in-human Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy candidate autogene cevumeran in patients with resected pancreatic ductal adenocarcinoma will be presented. The results of the Phase 1 trial were published in Nature. The candidate is currently being evaluated in an ongoing randomized Phase 2 trial in PDAC and is jointly being developed by BioNTech and Genentech, a member of the Roche Group. BioNTech will present preliminary results on the LuCa-MERIT-1 Phase 1 trial with its off-the-shelf, shared tumor-associated-antigen-based mRNA therapeutic cancer vaccine candidate BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer. The data show antitumor activity, consistent induction of immune responses in heavily pre-treated patients with advanced NSCLC, and a manageable safety profile. A trial in progress poster will inform on the global Phase 1/2a trial of the topoisomerase-1 inhibitor-based ADC candidate BNT324/DB-1311 targeting the immune checkpoint protein B7H3 in patients with pretreated advanced or metastatic solid tumors. The candidate is being jointly developed by BioNTech and Duality Biologics. BioNTech has established a diversified clinical oncology pipeline of more than 20 clinical programs along mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials. BioNTech is advancing the Company’s key programs into late-stage development with the aim to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024.