SELLAS Life Sciences Group and Cancer Center to Study Galinpepimut-S in Combination with Nivolumab in Patients with Malignant Pleural Mesothelioma

SELLAS Life Sciences Group (NASDAQ:SLS) has announced it has signed an agreement with Memorial Sloan Kettering Cancer Center for an investigator-sponsored clinical trial of SELLAS’ Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S with Bristol-Myers Squibb’s (NYSE:BMY) anti-PD-1 therapy, nivolumab, in patients with malignant pleural mestothelioma (MPM).

As quoted in the press release:

The Phase 1 open-label clinical study will enroll patients with MPM who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy with study drug provided by both SELLAS and Bristol-Myers Squibb. The principal investigator for the study will be Dr. Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program, Team Lead, Thoracic Disease Management Team, and Assistant Attending Physician in the Division of Thoracic Oncology, Department of Medicine at MSK.

The purpose of the trial is to determine if the administration of GPS in combination with nivolumab has the potential to demonstrate antitumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients. The study will also investigate the tolerability of the combination, evaluate the immunogenicity of the two agents administered together, by CD4+ and CD8+ T-lymphocytes (both peripherally and at the tumor site), and gauge the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations. In a randomized, controlled, blinded Phase 2 clinical trial in MPM patients completed in 2017, GPS monotherapy, given as maintenance after first line tumor-debulking multimodality treatment, demonstrated meaningful clinical activity with median survival of 22.8 months vs. 18.3 months in the control group (N=41) and with associated sustained immune responses (both CD4+ and CD8+) against the WT1 antigen while adverse events were mainly comprised of low grade reactions at the site of the injection.

“SELLAS is excited to embark upon this trial, as we look to expand the utility of GPS in combination with PD-1 inhibitors, and specifically nivolumab. The nivolumab/GPS immunotherapy combination is well positioned to exploit the unique features of each of these two agents through potential synergistic immune-based mechanisms of antitumor action. If positive, this clinical effort will allow us to consider advancing the clinical development of the combination of GPS and nivolumab in relapsed or refractory MPM as a potentially promising approach to treat patients with this recalcitrant thoracic malignancy,” stated Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Click here to read the full press release.