SELLAS Life Sciences Group announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the US National Heart, Lung and Blood Institute, National Institutes of Health (NIH). The research plan of the CRADA is designed to develop a novel AML MRD assay for monitoring the expression of multiple genes (including WT1) that can document the kinetics of minimal residual disease (MRD) in acute myeloid leukemia during treatment with SELLAS' most advanced product candidate, galinpepimut-S, the Company's WT1 cancer vaccine. Galinpepimut-S is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including AML, malignant pleural mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers. SELLAS plans to commence a pivotal Phase 3 trial of galinpepimut-S in AML patients where this new AML-MRD assay will be used as a biomarker test.
SELLAS will collaborate with Christopher S. Hourigan, DPhil, FACP, Chief of the Myeloid Malignancies Section, Hematology Branch, National Heart, Lung and Blood Institute (NHLBI), NIH, and Dr. Hourigan's research unit in this very promising research effort.
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 stated, "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. The development of the new MRD assay will be based on the encouraging results with RQ-PCR obtained at Dr. Hourigan's lab, a world leader in the AML MRD field, and from data generated by RNA-sequencing technology."
Sellas' goal is to further develop the assay to a point where it can be run as a routine assay by a CLIA-certified laboratory or to be developed as a companion diagnostic kit. Sellas looks forward to furthering our collaboration on many levels with the Myeloid Malignancies Section at the NIH.
Dr. Hourigan stated "Patients with AML need better options. The NIH established the Myeloid Malignancies Section with the mandate to investigate the detection, prevention and treatment of Acute Myeloid Leukemia relapse, with particular focus on novel immunotherapy. 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. 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". Dr. Hourigan noted that the current research plan contemplated by the CRADA will go on in a number of stages over an initial period of three years.
Dr. Angelos M. Stergiou, M.D., Vice-Chairman and Chief Executive Officer of SELLAS, commented: "SELLAS is honored and excited to be able to work with NIH and its world-renowned research scientists, particularly with Dr. Hourigan, and his collaborators at other US Institutions, who are developing a practical and viable solution for the detection of MRD in clinical trials and –potentially - in daily practice in the future. When we discussed the development of this assay with the NIH a few months ago, we thought that our Phase 3 AML trial was the ideal platform to evaluate it as a reflex test of the effect of our cancer vaccine on MRD. This CRADA very well characterizes what an ideal academic-industry collaboration should aim for in terms of common scientific and clinical goals in the best interest of patients and caregivers".