MAINZ – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology (“ESMO”) Congress 2024 in Barcelona, Spain from September 13-17, 2024. The oral and poster presentations will feature programs across BioNTech’s clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches.
“We believe that the future of cancer treatment will be driven by the combination of modalities, including immunomodulators, targeted and mRNA-based therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “At this year’s ESMO, we will present data from three clinical trials with BNT327/PM8002, one of the key backbones for our combination treatment strategy. This bispecific antibody will be an element in multiple novel combination treatment approaches that may open up new synergistic mechanisms of action. Our mRNA platforms are another important component of our combination strategy. At ESMO, we will present clinical data that further support the proof of concept of our mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens, showing early clinical activity across various indications.”
Highlights of BioNTech’s clinical stage programs to be presented at ESMO Congress 2024:
- Updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002 in various indications as monotherapy and in combination with chemotherapy will be presented. BNT327/PM8002 is an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization for vascular normalization and immunostimulation in the microenvironment of the tumor. Two oral presentations and one poster will provide clinical data updates for cohorts with advanced non-small cell lung cancer (“NSCLC”), locally advanced/metastatic triple-negative breast cancer (“TNBC”) and advanced renal cell carcinoma. BNT327/PM8002 is being developed in collaboration with Biotheus Inc. (“Biotheus”).
- Preliminary data from an ongoing clinical Phase 2 trial (NCT04534205) evaluating BNT113 in combination with PD-1 blockade and data from an investigator-initiated Phase 1/2 clinical trial (NCT03418480) evaluating BNT113 as monotherapy in HPV16-driven cancers will be presented. The data show immunogenicity and antitumor activity in heavily pre-treated patients in several HPV16-positive indications, including head and neck cancer, and a manageable safety profile. BNT113 is an investigational lipoplex-formulated uridine mRNA immunotherapy encoding E6 and E7 antigens of HPV16.
- Preliminary data of the randomized Phase 2 clinical trial (NCT05446298) 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 presented in a late-breaking session. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. (“OncoC4”).
- Follow-up data of activity and immune responses from the ongoing first-in-human Phase 1 clinical trial (NCT04503278) with BNT211 in patients with relapsed/refractory CLDN6+ solid tumors will be presented. BNT211 combines autologous CAR-T cells directed against the oncofetal antigen Claudin-6 (“CLDN6”) and an CLDN6-encoding CAR-T cell amplifying mRNA vaccine (“CARVac”). The data update shows signs of antitumor activity across all indications and an increased persistence of cancer-specific CAR-T cells when combined with CARVac, for example in patients with testicular and ovarian cancers. The safety profile is consistent with the previously published data of CAR-T therapies.
BioNTech has established a diversified clinical oncology pipeline including mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These investigational treatments are currently being evaluated in more than 32 clinical trials, including eight programs in advanced Phase 2 trials and two assets in pivotal Phase 3 trials globally. BioNTech is advancing the Company’s key programs into late-stage development with the aim of having ten or more potentially registrational trials in its oncology pipeline by the end of 2024.