Lycera Announces Initiation of Phase 1/2a Study ARGON of Immuno-Oncology Candidate LYC-55716 in Patients with Advanced Solid Tumors

1/4/2017

Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, announced today the initiation of a Phase 1/2a clinical trial of the Company’s novel immuno-oncology therapeutic candidate LYC-55716, in patients with advanced, relapsed, or refractory solid tumors.

“We continue to make rapid and significant progress in the development of our novel immune modulators. This is Lycera’s third clinical trial initiated in the past 12 months and our first immuno-oncology compound to enter the clinic,” said Paul Sekhri, President and CEO of Lycera. “The promising results of our preclinical program have provided confirmation that LYC-55716 modulates gene expression of RORgamma expressing T lymphocyte immune cells, resulting in enhanced effector function, as well as decreased immunosuppression, resulting in decreased tumor growth, and improved survival in in vivo preclinical models. This process of reprogramming immune cells is unique from other currently approved immunotherapies, and based on this, as well as the ability to deliver this agent orally, we believe LYC-55716 could be a significant advancement for patients.”

“Unlike many immunotherapies that either stimulate the immune system or reduce immune suppression, Lycera’s RORgamma agonist has demonstrated in preclinical models that it can simultaneously enhance T-cell function and reduce mechanisms of the immune suppression. Therapy with an oral RORgamma agonist may be able to demonstrate single agent activity, as well as show synergy in combination with other immunotherapies,” said John Nemunaitis, a principal investigator and Director of the Mary Crowley Medical Research Center, Dallas, TX. “We are excited to be working with Lycera and to be working on a compound with such a novel mechanism of action.”

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. The initial Phase 1 portion of the study is designed to find the biologically active or maximum tolerated dose of LYC-55716. The study will utilize a 3+3 study design, in which LYC-55716 will be administered orally in subjects with relapsed or refractory solid tumors. The primary endpoints are safety and tolerability, and the study is designed to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose. Upon dose determination, LYC-55716 will enter Phase 2a, which is expected to enroll approximately 40 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.

About LYC-55716

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.

About Lycera

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 has 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, has progressed into Phase 1/2a testing in patients with advanced solid tumors. Lycera has an exclusive strategic collaboration with Celgene Corporation to advance Lycera’s proprietary pipeline for cancer and immune-mediated diseases. In addition, Lycera had previously established collaborations with Merck to discover, develop, and commercialize small molecule therapies for autoimmune disorders.

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.