Dracen will develop sirpiglenastat (DRP-104) in combination with KEYTRUDA® in selected patients with Non-Small Cell Lung Cancer
Dracen Pharmaceuticals, Inc. (Dracen) announced today that it has entered into a clinical trial and supply agreement with Merck, known as MSD outside the United States and Canada, to evaluate the safety and efficacy of sirpiglenastat (DRP-104), Dracen’s glutamine antagonist, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with solid tumors.
A Phase 1b trial will enroll locally advanced or metastatic non-small cell lung cancer (NSCLC) patients to establish the safety/tolerability of sirpiglenastat in combination with KEYTRUDA. The trial is expected to begin by first quarter 2022.
Margaret Dugan, M.D., Chief Medical Officer of Dracen, commented: “Our novel glutamine antagonist sirpiglenastat has demonstrated potent single agent activity and synergy in combination with checkpoint inhibitors in both genetically modified and patient derived xenograft mouse models of NSCLC and SCCHN, we are excited to explore the combination study of sirpiglenastat with KEYTRUDA in these indications in the clinic.”
Dracen has previously announced that the U.S. Food and Drug Administration granted Fast Track designation for sirpiglenastat for the treatment of advanced, previously treated NSCLC patients whose tumors express mutations in KEAP1, NFE2L2, and/or STK11.
Today, Dracen also announces the adoption of sirpiglenastat by USAN and INN as the non-proprietary name for DRP-104. The USAN Council works in conjunction with the World Health Organization INN Expert Committee and national nomenclature groups to standardize drug nomenclature and establish rules governing the classification of new substances.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Dracen’s lead glutamine antagonist, sirpiglenastat (DRP -104), is currently in early-stage clinical development. The mechanisms of action for sirpiglenastat include: a) direct irreversible inhibition of tumor cell addiction to glutamine leading to substantial single agent activity and tumor regression; b) broad metabolic remodeling of the tumor microenvironment leading to enhanced anti-tumor immune activity; and c) stimulation of T effector, NK and NKT cells and inhibition of immunosuppressive MDSC and macrophage cells, leading to greater longterm durable responses and survival in animal models.
About Dracen Pharmaceuticals
Dracen Pharmaceuticals, Inc. is a privately held biotech company developing proprietary anti-cancer drugs that target immuno-metabolism. Dracen’s investors include Deerfield Management,; Osage University Partners; and The Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague). Dracen is headquartered in New York, NY with research operations in San Diego, CA.