Switzerland-based, development-stage, biopharmaceutical company SELLAS Life Sciences Group (SELLAS) has initiated a Phase l clinical trial to assess the safety and efficacy of its galinpepimut-S (WT1 cancer vaccine), in combination with nivolumab (Opdivo), Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, to treat ovarian cancer.
The Phase l trial is expected to enrol at least ten patients with recurrent ovarian cancer who are in second or greater clinical remission at Memorial Sloan Kettering Cancer Center, US.
Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the US.
Currently, more than 22,000 cases with ovarian cancer are diagnosed annually, and there are an estimated 15,500 deaths per year.
Memorial Sloan Kettering medical oncologist and principal investigator for the trial Dr Roisin O'Cearbhaill said: "For patients with advanced-stage ovarian cancer, the five-year survival rate is less than 30%, and there is a substantial and urgent need for new treatments that can prolong remission and survival in patients.
"Galinpepimut-S is a promising treatment for this disease because of WT1 showing an expression in ovarian cancer, and we believe T-cells, by combining galinpepimut-S and nivolumab, may specifically be directed towards the WT1 target and supports the rationale for its use in cancer immunotherapy approaches.
"In fact, studies have confirmed that ovarian cancer patients can exhibit immunologic competence even after multiple courses of chemotherapy, and immune activation has been shown to portend a better prognosis for these patients."
The company also reported positive clinical results for its WT1 vaccine, a late clinical-stage cancer immunotherapy, as monotherapy in both solid tumours (malignant pleural mesothelioma (MPM)) and hematological cancers (acute myeloid leukaemia (AML) and multiple myeloma (MM)).
Based on this progress, SELLAS is beginning Phase III clinical trials of galinpepimut-S in AML patients and MPM patients this year.
SELLAS chairman and chief executive officer Angelos Stergiou said: "We are advancing a broad clinical programme with galinpepimut-S to expand potential indications and develop in parallel applications for monotherapy and combined therapy in hematologic cancers and solid tumours.
"By the end of this year, we expect to have two pivotal trials and additional mid-stage studies in diverse indications, including a series of genetically defined Mismatch Repair cancers in a basket-trial design."