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Cancer Vaccine Receives Orphan Drug Designation

Survival doubled in mesothelioma trial

The FDA has granted orphan drug designation to the WT1 cancer vaccine (SELLAS Life Sciences Group) for the treatment of patients with malignant pleural mesothelioma (MPM). A phase 2 trial of the vaccine in MPM patients improved overall survival and doubled progression-free survival. SELLAS now plans to initiate a pivotal phase 2b/3 trial of the vaccine in patients with MPM by the third quarter of 2016.

SELLAS’ WT1 vaccine, a late clinical-stage cancer immunotherapy, is being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers.

The randomized, double-blind, placebo-controlled phase 2 study in MPM patients was conducted at Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. The study findings showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus 16.6 months overall survival for patients receiving placebo. Median progression-free survival (11.4 months) in the vaccine-treated patients was double that of the control arm (5.7 months). The vaccine also demonstrated a favorable safety and tolerability profile.

Source: PR Newswire; February 29, 2016.

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