Clinical Design

Phase I/II multi-center, open-label, single-arm study in patients with triple‑negative breast cancer (TNBC). After first‑line anticancer therapy combined with a standard anti‑PD‑1 monoclonal antibody and chemotherapy, the vaccine will be administered. The vaccine may be given for up to 24 weeks post‑surgery, depending on patient condition.

Objectives and Primary Endpoints

The primary objectives are to assess safety, tolerability, and immunogenicity, with pathological complete response (pCR) and immune cell activation included as primary endpoints. The study aims to determine whether the vaccine provides an immunological advantage over standard therapy.

Target and Mechanism

NECVAX-NEO1 is a personalized neoantigen peptide vaccine that targets each patient’s tumor-specific mutations to elicit a T‑cell response. Neoantigens refer to tumor‑specific mutant proteins, representing an immunological approach distinct from conventional anticancer agents.

Current Treatment Landscape and Differentiation

Triple‑negative breast cancer lacks targeted therapies, making immune checkpoint inhibitors and chemotherapy the main standards of care. Adding a tumor‑specific immune response via the vaccine may improve response rates and long‑term survival.

Expected Impact

If successful, the personalized cancer‑vaccine platform could be extended to solid tumors beyond breast cancer, increasing investment appeal for biotech ventures and large pharmaceutical companies. Conversely, failure would prompt a reassessment of the clinical development risk associated with neoantigen‑based vaccines.