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Individualized RNA-based cancer immunotherapy developed by BioNTech SE for the treatment of triple-negative breast cancer (TNBC). This approach, evaluated in the TNBC-MERIT Phase 1 trial, combines two complementary mRNA-based strategies: IVAC WAREHOUSE (IVAC_W_bre1_uID), which targets shared tumor-associated antigens (TAAs) tailored to the patient's tumor profile, and IVAC MUTANOME (IVAC_M_uID), an on-demand vaccine targeting up to 20 patient-specific neoantigens identified through next-generation sequencing. The active ingredients are messenger RNA molecules formulated as RNA-lipoplexes for intravenous administration. These vaccines are designed to induce potent and durable neoantigen-specific T-cell responses, with recent data showing long-term relapse-free survival in a majority of treated patients.
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