8 November 2017 - - By examining human tumor samples and bioinformatic datasets for retinoic acid-related orphan receptor gamma (RORgamma) expression, as well as RORgamma-related biology and immune profiles correlated with clinical activity, Ann Arbor, Michigan-based immune modulatory medicines developer Lycera Corp. has selected multiple tumor types for inclusion in the ongoing ARGON study of its novel immuno-oncology therapeutic candidate, RORgamma agonist LYC-55716, the company said.
The ARGON trial (Trial of RORgamma Agonist LYC-55716 in Advanced Cancer) is a Phase 1/2a study of LYC-55716 in patients with advanced, relapsed, or refractory solid tumors.
Tumor types selected are non–small-cell lung cancer, squamous cell head and neck cancer, ovarian cancer, urothelial cancer, renal cell cancer, and esophageal / gastric cancer.
The initial Phase 1 portion of the ARGON study was designed to find the biologically active or maximum tolerated dose of LYC-55716.
Upon determination of the recommended Phase 2a dose, Lycera has initiated Phase 2a, which is expected to enroll approximately 75 patients.
The primary efficacy endpoint of the Phase 2a portion of the study will be objective response rate according to response evaluation criteria in solid tumors.
LYC-55716 is a first in class oral, selective RORgamma agonist that modulates gene expression to reprogram immune cells for improved function, as well as decrease immunosuppressive mechanisms, resulting in decreased tumor growth and enhanced survival in in vivo preclinical models of cancer.
Privately held Lycera is a biopharmaceutical company developing novel oral immune modulators for the treatment of autoimmune diseases and cancer. Based on expertise in immune metabolism, cell signaling, and immune cell differentiation, the company commenced multiple clinical programmes in 2016.