On February 12, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported an update on its galinpepimut-S (GPS) and nelipepimut-S (NPS) clinical development programs (Press release, Sellas Life Sciences, FEB 12, 2019, View Source [SID1234533257]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Company announces that Richard Maziarz, M.D., Medical Director of the Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program at the Knight Cancer Institute and Professor of Medicine at Oregon Health and Science University (OHSU) in Portland, OR, and Roisin O’Cearbhaill, M.D., Assistant Attending Physician in Gynecologic Medical Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), will serve as co-principal investigators of the Company’s Phase 1/2 open-label, non-comparative, multicenter, multi-arm study of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with selected WT1-positive advanced cancers, including both hematologic malignancies and solid tumors. This study, which is being conducted under a Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck (known as MSD outside the United States and Canada), will assess the efficacy and safety of the combination, with exploratory long-term follow-up for overall survival and safety. The study will enroll approximately 90 patients at up to 20 centers in the United States. The initial tumor types to be treated will be acute myelogenous leukemia (AML) (patients unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant) and ovarian cancer (second or third line), to be followed by triple negative breast cancer (second line), small cell lung cancer (second line), and colorectal cancer (third or fourth line).
"We are thrilled to announce that Drs. Maziarz and O’Cearbhaill will serve as co-principal investigators of this important study," said Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Both Rich and Roisin will be indispensable in overseeing the scientific rigor of the investigation, helping to interpret both clinical and correlative immuno-response data, and guiding us to optimally advance the development of GPS as a uniquely positioned active immunizer of the peptide vaccine type for the treatment of recalcitrant malignancies in the presence of measurable disease."
Additionally, the Company announces preliminary immune response data in a subgroup of patients with triple-negative breast cancer (TNBC) from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical study of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS, NeuVax) targeting HER2 low-expressing breast cancer patient cohorts. These data originate from an analysis of the patterns of induction of antigen (NPS)-specific T-cell responses over time in patients treated in this study. CD8+ cytotoxic T-lymphocytes (CTLs) from peripheral blood samples from study patients with TNBC were measured using specifically designed NPS-specific dextramers in a flow cytometry-based assay in duplicate. In 64 evaluable TNBC patients (39 in the NPS plus trastuzumab arm; 25 in the trastuzumab alone arm) across a median of four time-points (including baseline), NPS + trastuzumab administration generated up to 3-fold higher frequencies of NPS-specific CTLs compared to trastuzumab alone. Moreover, CTL frequencies were much higher among non-recurrent patients compared with those who recurred (on either arm). The complete set of data from these correlative analyses will be presented in an upcoming major scientific meeting.
"These new data provide important insights on the immunobiological mechanism underlying the statistically significant and clinically meaningful decrease in detectable tumor relapses and associated increase in 24-month disease-free survival (DFS) rate with the combination of NPS plus trastuzumab versus trastuzumab alone observed within the TNBC cohort of the Phase 2b study we have previously reported. We are looking forward to completing the underlying correlative analyses in order to further dissect the intriguing association between induction of antigen-specific T-cell immunity and clinical effect post-vaccination, which strongly suggests a contribution of NPS in the emergence of antitumor activity in TNBC patients in the adjuvant treatment setting. We are continuing our discussions with the FDA on the most optimal development path forward for NPS in TNBC and will provide the immune response data to the Agency as well," commented Dr. Stergiou.
Herceptin and Keytruda are registered trademarks of Genentech, Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.