Sellas Life Sciences Group is developing the galinpepimut-S vaccine as a potential treatment for patients with cancers ranging from mesothelioma and myeloma to leukemia and ovarian cancer, and is moving forward with clinical studies.
The galinpepimut-S vaccine targets the WT1 protein, which is widely expressed in multiple malignancies and considered a crucial target for cancer therapy. Previous Phase 1 and Phase 2 clinical trials have shown that galinpepimut-S induces a strong T-cell immune response against cancer cells producing this protein, potentially preventing post-surgery relapses in patients.
In an interview to Immuno-Oncology News, Angelos Stergiou, MD, CEO and vice chairman of the board, and Nicholas Sarlis, MD, senior vice president and chief medical officer of Sellas Life Sciences Group, addressed the clinical program planned for galinpepimut-S vaccine.
“We have studied galinpepimut-S in acute myeloid leukemia, mesothelioma, multiple myeloma and, more recently, ovarian cancer,” they said. “We are planning to study this approach in several other cancer types, including a specific subtype of colorectal cancer, lung cancer (non-small cell and possibly also small cell lung carcinoma), and potentially a brain malignancy called glioblastoma multiforme, and also chronic myeloid leukemia.”
“Other possible tumor types that could be potentially targeted include certain soft tissue malignancies (sarcomas), a very rare blood cancer called plasma cell leukemia, or head and neck cancer,” they added. “The majority of these potential trials are currently in the planning stage, where we are examining the realistic feasibility of running all these studies.”
Some of these trials may test the vaccine in combination with other anticancer therapies to achieve a faster and stronger clinical response.
“Galinpepimut-S could very easily be combined with other anticancer therapies, particularly those that are activating the immune system,” they said. “This would potentially lead to strong, sustained and clinically effective immune responses, and could lead to very powerful tumor killing and evidence of clinical regression of existing measurable tumor deposits.”
Sellas has several trials with galinpepimut-S that are either ongoing or planned, including a Phase 3 trial in acute myeloid leukemia (AML) and a number of Phase 1 trials in ovarian cancer, among others.
“We are prepared to initiate the Phase 3 large global clinical study of galinpepimut-S in patients with AML after initial induction chemotherapy and achievement of their first complete remission (CR1); this study will focus only on patients older than 60 years of age,” Stergiou and Sarlis said. “This will be a global effort, which could provide preliminary efficacy results as early as toward the end of 2019, which, if positive, could potentially lead to a new product registration (after discussion with and positive decision by regulatory authorities). The study is ready to start by around end of Q2/early Q3 this year.”
“A phase 1/2 study is currently underway in patients with recurrent ovarian cancer after their first (or subsequent) successful ‘salvage’ therapy (with no measurable residual disease after that therapy),” they added. “In this study, we combine galinpepimut-S with the checkpoint inhibitor nivolumab (Opdivo). This study has already accrued more than half of its total number of patients, and it will report both immune response effects of the combination treatment as well as clinical outcomes later this year and next.”
According to Stergiou and Sarlis, if clinical results meet each trial’s endpoints, Sellas will work with both the U.S. Food and Drug Administration and European Medicines Agency “to obtain regulatory registration/ market authorization in the respective territories as quickly as possible.”