BNT111
- Generic Name
- BNT111
- Drug Type
- Biotech
- Background
BNT111 is an investigational cancer immunotherapy under development for advanced melanoma. It consists of a fixed combination of mRNA-encoded, tumor-associated antigens.
BioNTech Advances Oncology Pipeline with BNT327/PM8002 and mRNA Immunotherapies
• BioNTech is progressing BNT327/PM8002, a bispecific antibody, into global clinical trials for first-line small cell lung cancer and non-small cell lung cancer.
• The company plans to initiate additional trials combining BNT327/PM8002 with antibody-drug conjugates (ADCs) in 2025, expanding its combination strategy.
• BioNTech's mRNA cancer immunotherapy, autogene cevumeran, is being evaluated in a Phase 2 trial for muscle-invasive urothelial carcinoma in combination with nivolumab.
• Clinical data readouts are expected in 2025 and 2026 from multiple randomized trials of personalized and off-the-shelf mRNA cancer immunotherapy candidates.
mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy
• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment.
• BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab.
• Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers.
• The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.
UK Partners with BioNTech on Clinical Trials of mRNA Cancer Therapies
The UK has partnered with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies through clinical trials, leveraging mRNA technology. This collaboration, extending to 2030, also includes the potential supply of commercial therapies and covers infectious disease targets. BioNTech will establish an R&D centre in Cambridge and an office in London, with the possibility of manufacturing investments in the UK.
BioNTech Advances Oncology Pipeline with Bispecific Antibody and mRNA Cancer Vaccine Programs
• BioNTech presented clinical data for its bispecific antibody candidate BNT327/PM8002 and mRNA cancer vaccine candidate BNT113, showcasing progress in its oncology pipeline.
• Phase 2 dose optimization trials have commenced for BNT327/PM8002 in small-cell lung cancer and triple-negative breast cancer, informing planned Phase 3 trials.
• A Phase 2 clinical trial is underway to assess the mRNA-based individualized cancer vaccine candidate autogene cevumeran in high-risk muscle-invasive urothelial cancer.
• BioNTech successfully launched variant-adapted COVID-19 vaccines for the 2024/2025 vaccination season and reported Q3 2024 revenues of €1.2 billion.
Melanoma Treatment Landscape Evolves with Novel Immunotherapies and Targeted Approaches
• The FDA granted fast-track approval to Amtagvi, a Tumor-Infiltrating Lymphocyte (TIL) therapy, for metastatic melanoma patients who have failed other treatments, marking a significant advancement in cellular immunotherapy.
• Neoadjuvant immunotherapy has become the standard of care for stage III melanoma patients with resectable tumors, as highlighted at the European Society for Medical Oncology (ESMO) Congress.
• Over 170 melanoma pipeline therapies are under development by 150+ companies, including IO Biotech, Moderna, Merck, and BioNTech, targeting various stages and mechanisms of the disease.
BioNTech's mRNA Immunotherapy BNT111 Shows Positive Phase 2 Results in Advanced Melanoma
• BioNTech's BNT111, an mRNA immunotherapy, demonstrated a statistically significant improvement in objective response rate (ORR) when combined with cemiplimab in advanced melanoma patients.
• The Phase 2 trial evaluated BNT111 plus cemiplimab versus cemiplimab alone in patients with unresectable stage III or IV melanoma who progressed after anti-PD-(L)1 treatment.
• BNT111 leverages BioNTech's FixVac platform, encoding four melanoma-associated antigens to stimulate an immune response against cancer cells expressing these antigens.
• The combination therapy was well-tolerated, with a safety profile consistent with previous trials, marking a step towards personalized cancer medicine using mRNA technology.
Drug Development Updates
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