immunotherapeutic in development for hematological malignancies and solid tumors characterized by an overexpression of the WT1 (Wilms Tumor Protein) antigen. The WT1 antigen is one of the most widely expressed cancer antigens and ranked by the National Cancer Institute (NCI) as the number 1 target for immunotherapy. Traditional approaches have not been able to address the WT1 protein, as WT1 is not druggable with small molecules and is intracellular and inaccessible to antibodies. The company has a close working relationship with MSKCC, who is also a shareholder.

The Company plans to initiate a pivotal Phase III study in H1:17 in acute myeloid leukemia (AML) as well as malignant pleural mesothelioma (MPM) by H2:17 and is currently conducting Phase I and Phase II studies in ovarian cancer (combination with BMS’s nivolumab (Opdivo®) and multiple myeloma (MM) and will advance additional studies into the clinic. Phase II data in AML and MPM have shown positive safety and survival trends, with median OS in AML of 61.8 months vs. ~12-15 months for best standard treatment and median OS in MPM of 24.8 months vs.16.6 months in the control arm. Further recent data in multiple myeloma has shown an 86% overall survival rate after 18 months in patients with high-risk cytogenetics following stem cell transplantation. The US FDA granted orphan designations and fast track designations for SELLAS WT1 therapy, galinpepimut-S, for AML and MPM and the European EMA granted orphan designation for AML and MPM.

Galinpepimut-S has the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance to avoid or significantly delay tumor recurrence. Its use in this setting is aided by an attractive safety profile not found in standard of care therapies.