FDA Grants Orphan Drug Designation to WT1 Cancer Vaccine for Malignant Pleural Mesothelioma

“The FDA granted orphan drug designation to the WT1 cancer vaccine for the treatment of malignant pleural mesothelioma.

“The FDA based the designation on results from a randomized, double blind, placebo-controlled phase 2 trial of the WT1 vaccine (SLS-001, SELLAS Life Sciences) in 40 patients with malignant pleural mesothelioma treated at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

“Results showed patients assigned the vaccine experienced longer median OS (21.4 months vs. 16.6 months) and median PFS (11.4 months vs. 5.7 months) than those assigned placebo. The vaccine also demonstrated a favorable safety profile, according to researchers.

“A phase 2b/3 trial in malignant pleural mesothelioma is expected to begin by the third quarter of this year.”