CSF-470 vaccine

CSF-470 is an irradiated, allogeneic, multi-cell-line melanoma cell vaccine administered with BCG and recombinant human GM-CSF as adjuvants for adjuvant immunotherapy in resected cutaneous melanoma stages IIB–III. It consists of 1.6×10^7 lethally irradiated cells from four melanoma cell lines (MEL-XY1, MEL-XY2, MEL-XY3, MEL-XX4), expressing shared melanoma-associated antigens and gangliosides (e.g., GD2, GD3). Proposed mechanism: BCG and GM-CSF recruit and activate antigen-presenting cells at the injection site, which phagocytose vaccine tumor antigens and prime Th1-skewed T-cell responses; the vaccine elicits both innate and adaptive immunity with increased IFN-γ–secreting T cells and expansion of tumor-reactive TCR clonotypes. In a randomized Phase II (CASVAC-0401, NCT01729663), CSF-470 plus BCG and rhGM-CSF improved distant metastasis–free survival versus interferon-α2b in stages IIB–III cutaneous melanoma. The vaccine was developed and manufactured in Argentina within the Centro de Investigaciones Oncológicas-FUCA GMP facility, with clinical sponsorship by Laboratorio Pablo Cassará. Evidence supports persistent vaccine-specific T-cell responses over a 2-year regimen and trafficking of vaccine-primed clonotypes to cutaneous metastases.

Other names

Vaccimel