Cohort Expansion In Select Tumors of Interest

NEW YORK and ANN ARBOR, Mich., Oct. 19, 2017 /PRNewswire/ — Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced the initiation of the Phase 2a portion of the company’s Phase 1/2a ARGON study of its novel immuno-oncology therapeutic candidate, 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 advanced, relapsed or refractory solid tumors. The Phase 2a is expected to enroll a total of approximately 75 patients with advanced cancer in six tumor cohorts (Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Cancer of the Head and Neck (SCCHN), Ovarian Cancer, Gastric and Esophageal Cancer, Bladder Cancer, and Renal Cancer). These tumor types were selected based on proprietary insights on RORgamma agonist mechanisms, bioinformatics, and input from global immuno-oncology experts.

“We are excited with the rapid progress of our RORgamma program, which recently reported favorable preliminary safety findings and promising clinical activity from the Phase 1 portion of the study,” said Paul Sekhri, President and CEO of Lycera. “With two product programs in Phase 2 testing, LYC-55716 as well as our novel ATPase modulator LYC-30937-EC (Enteric Coated), we continue our leadership in the advancement of selective small molecule immune modulators that address unmet needs among broad patient populations.”

“The novel immuno-oncology agent, LYC-55716, stimulates the immune system to kill cancer cells while reducing immunosuppressive mechanisms which allow cancer cells to evade detection,” said Erika P. Hamilton, MD, Director of the Breast & Gynecologic Research Program at Sarah Cannon Research Institute. “The preliminary data from Phase 1 demonstrated a favorable safety profile and suggested signs of disease stabilization among heavily pretreated patients in early clinical evaluation. We look forward to continuing our research to advance novel immune therapies for patients across tumor sites.”

The Phase 2a expansion trial is focused on detecting signals of clinical activity in six tumor cohorts selected based on a unique insights that Lycera brought to understanding the mechanism of action of the RORg agonist and other selected criteria related to immuno-oncology. Based on current timelines, the Phase 2a portion of the ARGON trial is expected to complete patient enrollment by mid-2018.

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 study enrolled a total of 32 patients, and was designed to find the biologically active or maximum tolerated dose (MTD) of LYC-55716. The study is utilizing a 3+3 study design, in which LYC-55716 is administered orally in subjects with relapsed or refractory solid tumors. The primary endpoints are safety and tolerability and determination of the recommended Phase 2a dose, while secondary endpoints

include objective responses according to response evaluation criteria in solid tumors (RECIST) v1.1 criteria. Based upon determination of the recommended Phase 2a dose, LYC-55716 entered 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 RECIST.

In September 2017, Lycera reported favorable preliminary safety data and promising clinical activity with long-term disease stabilization in heavily pretreated patient population from the Phase 1 portion of the ARGON study at the European Society for Medical Oncology (ESMO) Congress, Madrid, Spain. Findings from the first three cohorts (N=15) in the Phase 1 portion demonstrated that LYC-55716 was welltolerated and there were no treatment-related serious adverse events during the trial’s 28-day treatment period and beyond. In the first two cohorts (N=11) eligible for response assessment, 4 patients were observed to have long-term stable disease (SD), including 2 patients with disease stabilization for greater than 7 months who remained on treatment at the time of the presentation.

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, gutdirected 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.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years. Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com.

 

CONTACT: Justin Jackson, Burns McClellan, 212-213-0006, ext. 327, jjackson@burnsmc.com