SELLAS™ Life Sciences Announces Entry Into Cooperative Research and Development Agreement With National Heart, Lung and Blood Institute, National Institutes of Health

ZUG, Switzerland and NEW YORK, Sept. 14, 2016 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS or the Company), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancer, today 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".  

About National Heart, Lung and Blood Institute, National Institutes of Health

The mission of the National Heart Lung and Blood Institute (NHLBI) Division of Intramural Research (DIR) is to perform robust scientific and clinical research leading to a better understanding of biology and clinical pathology. To attain this goal, we have built a strong basic science foundation and coupled it closely with innovative technology development and outstanding clinical research both at the NIH Clinical Center and in partnership with local hospitals.

The purview of our research is broad, encompassing investigations into the basic principles of molecular, cellular, and organ-level biology and their relationship to disease.  Some current areas of fundamental interest include single molecule structure; protein assembly; molecular and cell biology; cell signaling and motility; membrane trafficking; physiology; systems biology; engineering and technology development. Insights into disease mechanisms derived from basic studies form the basis for translational research into new diagnostic and therapeutic approaches.

DIR investigators also conduct concept-based clinical studies in the areas of interventional and surgical cardiology; pulmonary medicine; sickle cell anemia; bone marrow transplant; and hematologic disorders.

About SELLAS' WT1 Cancer Vaccine, Galinpepimut-S 
SELLAS' WT1 vaccine (generically designated as galinpepimut-S) is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 antigen is a transcription factor that is not generally expressed in normal adult cells, but appears in a large number of cancers, as well as in certain cancer stem cells. WT1 has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy. While WT1 has not been druggable by traditional approaches, it can be targeted by the immune system. Specifically, a number of different peptide sequences from the WT1 antigen have been identified as immunogenic and capable of stimulating cytotoxic T-cells that can target and kill WT1-expressing cancer cells. Studies also have shown that WT1 does not provoke tolerization and that patients' T-cells can remain reactive to the antigen over time.

Galinpepimut-S, originally developed by MSK and licensed to SELLAS, comprises four modified peptide chains that induce a strong innate immune response (CD4+/CD8+ T-cells) against the WT1 antigen. Galinpepimut-S is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, galinpepimut-S may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. Overall, SELLAS' galinpepimut-S could target over 20 cancers that over-express WT1, many of which are associated with relapse rates of up to 80% or more, as seen in patients with AML and MPM.

About SELLAS Life Sciences Group 
SELLAS Life Sciences Group is a development-stage biopharmaceutical company focused on innovative products to treat cancer, particularly its lead product candidate, galinpepimut-S. Galinpepimut-S is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is poised to advance into pivotal Phase 2b and 3 trials in acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM) in the US and Europe in early 2017. SELLAS™ recently received orphan drug designations by the US FDA, as well as the European EMA, for galinpepimut-S in AML and MPM, as well as Fast Track Designation for AML by the US FDA.

Galinpepimut-S also is in various development phases in multiple myeloma, ovarian cancer, and other indications as monotherapy or in combination with other immuno-oncology agents. SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA and London, UK.

SOURCE SELLAS Life Sciences Group