Sellas Life Sciences announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to WT1 cancer vaccine for the treatment of patients with Malignant Pleural Mesothelioma (MPM).

The Company recently reported positive results from a randomized, double-blind, placebo-controlled Phase 2 trial of WT1 vaccine in MPM patients. Study findings showed that patients treated with the WT1 cancer vaccine achieved a median overall survival of 21.4 months vs. 16.6 months in the placebo control arm. Treatment with the vaccine also resulted in a median progression-free survival of 11.4 months, double that of the control arm, 5.7 months. Based on these results, Sellas plans to initiate a Phase 2b/3 study for WT1 cancer vaccine in MPM patients by the third quarter of 2016.

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The WT1 cancer vaccine comprises of four modified peptide chains that induce a strong innate immune response (CD4+/CD8+ T-cells) against the WT1 antigen. It is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target.

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