SELLAS Life Sciences has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Heart, Lung and Blood Institute of the National Institutes of Health (NIH).
CRADA is a tool to establish collaborations between a government agency and the private sector. In this case, the collaboration’s goal is to develop a gene monitoring assay that can document the kinetics of minimal residual disease (MRD) in adult acute myeloid leukemia (AML) during treatment with the company’s WT1 cancer vaccine.
SELLAS’s WT1 vaccine (galinpepimut-S) is a clinical-stage immunotherapy for hematologic cancers and solid tumors, including malignant pleural mesothelioma.
The WT1 vaccine, originally developed by Memorial Sloan Kettering Cancer Center and licensed to SELLAS, is composed of four modified peptide chains that stimulate specific immune cells to respond against the WT1 antigen, which is usually not expressed in healthy adult cells but is present in many cancers.
The advances made with the new CRADA collaboration for the AML MRD assay may also be promising for advances in malignant pleural mesothelioma immunotherapies.
“The objective of this collaboration is to develop a robust MRD-assay that can be widely used in patients with AML undergoing therapy with galinpepimut-S and with other therapies in which the evaluation of MRD is crucial to monitor the effect of the drug and to predict relapse,” Dr. David Scheinberg, MD, PhD, chairman of SELLAS Scientific Advisory Board and chairman of Memorial Sloan Kettering’s Pharmacology Program and the Center for Experimental Therapeutics, said in a press release.
Sellas’ goal is to develop the assay to a point where it can be run as a routine assay by a certified laboratory or to be developed as a companion diagnostic kit.
“Patients with AML need better options,” said Christopher S. Hourigan, DPhil, FACP, chief of the Myeloid Malignancies Section, Hematology Branch, at the NIH’s National Heart, Lung and Blood Institute.
“This new collaboration with SELLAS and their galinpepimut-S program in AML aligns well with our mission and we are excited to use this opportunity to refine and advance our research in molecular assays for detection of minimal residual disease (MRD) in AML patients,” Hourigan said.
“Our hope is work in the laboratory may be able to be translated by others into a clinical test, allowing both earlier diagnosis of relapse and to provide a better tool for monitoring AML patient’s progress during treatment,” he added.
Hourigan said the agreement’s current research plan will have different stages over three years.
SELLAS previously reported promising results from a Phase 2 clinical trial evaluating the vaccine’s effect on the survival of patients with malignant pleural mesothelioma. The trial compared a WT1 vaccine combination treatment to a control treatment, and results indicated the vaccine extended overall survival and doubled progression-free survival.
Based on these findings, which included reasonable safety and tolerability profiles, the company plans to begin a Phase 2b/3 WT1 vaccine trial in patients with malignant pleural mesothelioma later this year.