Data Support the Enrollment of Multiple Solid Tumor Cohorts in Trial

NEW YORK and ANN ARBOR, MI, USA I November 7, 2017 I Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced the presentation of scientific data supporting the selection of tumor types for Lycera’s ongoing Phase 1/2a ARGON study of its novel immuno-oncology therapeutic candidate, RORgamma agonist LYC-55716. By examining human tumor samples and bioinformatic datasets for RORgamma expression, as well as RORgamma-related biology and immune profiles correlated with clinical activity, Lycera has selected multiple tumor types, including non–small-cell lung cancer, squamous cell head and neck cancer, ovarian cancer, urothelial cancer, renal cell cancer, and esophageal / gastric cancer for inclusion in the Phase 2a portion of the ARGON study. These analyses will be presented at this week’s annual meeting of the Society for Immunotherapy of Cancer’s (SITC), which is taking place in National Harbor, Maryland, November 8-12, 2017.

“We are pleased to report the results of our research and analyses, which further underscore the broad potential applicability of LYC-55716 to the treatment of solid tumors for which there are compelling unmet needs,” said Paul Sekhri, President and CEO of Lycera. “In addition to these research findings, we also recently announced promising safety data and evidence of disease stabilization in the early cohorts of the Phase 1 dose-finding portion of our clinical trial for this next-generation approach to cancer immunotherapy. Based on this progress, we initiated the Phase 2a portion of the ARGON study earlier this quarter, and anticipate achieving full enrollment in the study by mid-2018.”

SITC Poster Details

Poster/Abstract Number: P253

Poster Title: “Prioritizing tumor types for treatment with a novel immunotherapy: LYC-55716 a small-molecule RORg agonist”

Time, Date & Location: Friday, Nov 10, 2017, 12:30 PM – 8:00 PM, Prince George Exhibition Hall DE, Gaylord National Hotel & Convention Center

Authors: Xiao Hu1, Xikui Liu1, Hongxiu Li1, Madhumita Bogdan1, Yilin Gao1, Brian Fox2, H. Jeffrey Wilkins3, Laura Carter1

1Lycera Corp., Ann Arbor, MI; 2Celgene Corp., Seattle, WA; 3Lycera Corp., Plymouth Meeting, PA.

About the ARGON Trial

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 ARGON study was designed to find the biologically active or maximum tolerated dose (MTD) of LYC-55716. The study utilized a 3+3 study design, in which LYC-55716 was administered orally in subjects with relapsed or refractory solid tumors. The primary endpoints were safety and tolerability and determination of the recommended Phase 2a dose, while secondary endpoints included objective responses according to RECIST v1.1 criteria. Upon determination of the recommended Phase 2a dose, LYC-55716 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.

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 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 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.

SOURCE: Lycera