Biopharmaceutical firm SELLAS Life Sciences Group has entered a clinical trial collaboration and supply agreement with Merck to conduct a combination clinical trial targeting multiple cancer types.
As part of the deal, a Phase I/II combination clinical trial will be initiated to evaluate SELLAS’ Wilms tumour-1 (WT1) targeting peptide immunotherapeutic agent, galinpepimut-S, with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with five cancer indications, including both hematologic malignancies and solid tumours.
The trial is designed to determine if the administration of galinpepimut-S in combination with KEYTRUDA has the potential to show clinical activity in the presence of macroscopic disease, where monotherapy with either agent would have a more limited effect.
The company noted that the foundation for the trial is based upon the presumed immunobiologic and pharmacodynamic synergy between the two agents, where the negative influence of tumour microenvironment factors on the immune response is mitigated by PD-1 inhibition.
It then allows the patients’ own immune cells to invade and destroy cancerous growth deposits specifically sensitised against WT1.
SELLAS vice-chairman and chief executive officer Angelos Stergiou said: “SELLAS is enthused to embark upon this trial with MSD as we look to expand the utility of galinpepimut-S in combination with other agents.
“The KEYTRUDA/galinpepimut-S active immunotherapy combination is 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 evaluate indications, whereby galinpepimut-S and KEYTRUDA could be further studied in combination, providing the basis for a potentially promising cancer immunotherapy approach in the future.”
Scheduled to begin in the first half of next year, the trial will use the combination to explore the cancer indications such as colorectal, ovarian, small cell lung, triple-negative breast and acute myeloid leukaemia (AML).
It will assess the efficacy and safety of the combination, comparing overall response rates (ORRs) and immune response markers achieved with the combination versus prespecified rates based on those seen with KEYTRUDA alone in comparable patient populations.
Currently, galinpepimut-S is expected to enter a pivotal, Phase III clinical trial in patients with AML and is also in various development phases in multiple myeloma (MM) and ovarian cancer.