First-In-Class RORgamma Agonist Also Advancing in Phase 2a Portion of ARGON Study
NEW YORK and ANN ARBOR, January 4, 2018 — Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced the initiation of a Phase 1b clinical trial of the company’s novel immuno-oncology therapeutic candidate, LYC-55716, in combination with pembrolizumab (KEYTRUDA®). LYC-55716 is a first-in-class oral, selective retinoic acid-related orphan receptor-gamma (RORgamma) agonist designed to reprogram the immune system in patients with solid tumors. Lycera’s Phase 1b study is expected to enroll a total of approximately 18 patients with metastatic non-small cell lung cancer (NSCLC). LYC-55716 is also advancing in the Phase 2a portion of the company’s Phase 1/2a ARGON trial, a monotherapy study that initiated in October 2017 and is enrolling patients with advanced cancer in six tumor cohorts, including individuals with NSCLC.
“The oncology community is very interested in finding novel immunotherapy approaches that can stand alone or complement the activity of PD-1 inhibition. PD-1 inhibition has completely changed oncology, but use of these agents alone appears to have convincing activity only in a minority of patients,” said D. Ross Camidge, M.D., Ph. D., Director of Thoracic Oncology at the University of Colorado Cancer Center and study investigator. “Many different combinations of specific novel immunotherapies are being tried, but the challenge has been selecting which combination is right for which patient. In theory, the very broad immune reprogramming potential of RORgamma agonists is, therefore, very attractive to explore for synergy with PD-1 inhibition. I am very pleased to be involved with this research initiative and look forward to assessing this agent in this novel combination.”
“We are thrilled with the progress of our cancer immunotherapy program, which is now advancing in two proof-of-concept clinical studies of LYC-55716 in monotherapy and combination treatment, respectively,” said Paul Sekhri, President and CEO of Lycera. “Last year, we reported key results at major peer-reviewed conferences, including encouraging safety findings from the Phase 1 portion of the company’s ARGON trial, as well as signs of disease stabilization among heavily pretreated patients in early clinical evaluation. Based on current timelines, we anticipate we will be able to report interim findings from ARGON by the second half of this year, and early safety and efficacy data from the Phase 1b combination study in the middle of 2019.
About the LYC-55716 Phase 1b Combination Trial
The Phase 1b trial is a multi-center study evaluating the combination of LYC-55716 and KEYTRUDA® (pembrolizumab) in 18 patients with advanced, relapsed, or refractory NSCLC. The study will collect pre- and post-treatment tumor biopsies, as well as blood samples. The primary endpoint of the study is safety and tolerability. Secondary endpoints include evaluation of immune biomarkers in tumor tissue and circulating immune markers in the blood, as well as objective response rate according to RECIST v1.1 criteria. This novel clinical study is being conducted and sponsored by Lycera.
LYC-55716 is a first in class oral, selective RORgamma agonist. The retinoic acid-related orphan receptor gamma (RORgamma) is a nuclear receptor transcription factor that acts as an immune cell master control switch. RORgamma agonists modulate 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. Essentially, Lycera’s RORgamma agonist approach “removes
the brake” and “pushes on the accelerator” of immune function. LYC-55716 is an investigational compound that is not approved for any use in any country.
Lycera is a biopharmaceutical company developing novel oral immune modulators for the treatment of autoimmune diseases and cancer. Based on successful progress of its world-class R&D platform, including expertise in immune metabolism, cell signaling, and immune cell differentiation, Lycera commenced multiple clinical programs in 2016. The company is advancing a wholly owned, oral, gut-directed ATPase modulator, designated LYC-30937-EC, for the treatment of autoimmune disease, and has entered Phase 2 clinical studies in patients with ulcerative colitis and psoriasis. A second product candidate, LYC-55716, an oral RORgamma agonist, is progressing in the Phase 1/2a ARGON trial, a monotherapy study in patients with advanced solid tumors, as well as in a Phase 1b combination trial. Lycera has an exclusive strategic collaboration with Celgene Corporation to advance Lycera’s proprietary pipeline for cancer and immune- mediated diseases.
Lycera’s leadership possesses deep experience in drug discovery, development, and commercialization and has established close relationships with renowned thought leaders and clinical researchers worldwide. Lycera was founded in 2006 based on an initial scientific platform in-licensed from the University of Michigan. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures, and EDF Ventures.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
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