Lycera to Present on First-in-class RORgamma Agonist Candidate LYC-55716 at the 2018 ASCO Annual Meeting

LYC-55716 advancing in Phase 2a portion of ARGON monotherapy study and in Phase 1b study in combination with pembrolizumab

NEW YORK and ANN ARBOR, Mich., May 30, 2018 /PRNewswire/ -- Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced presentations of the company’s novel immuno-oncology therapeutic candidate, LYC-55716, to take place during the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 1-5, 2018, in Chicago, IL. 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.

Details for the poster presentations are as follows:

Abstract Title: A Phase 2a open-label, multicenter trial of the safety and efficacy of LYC-55716, a first-in-class oral, small-molecule RORγ agonist to treat select solid tumors (Poster Board: #432b; Abstract TPS2617)

• Poster Session Title: Developmental Therapeutics--Clinical Pharmacology and Experimental Therapeutics
• Presentation Date & Time: Monday, June 4, 8:00 AM - 11:30 AM CT
• Location: Exhibit Hall A, McCormick Place Convention Center

Abstract Title: A Phase 1b trial of RORγ agonist LYC-55716 in combination with pembrolizumab to evaluate safety, efficacy, and immune biomarker profiles in patients with metastatic non-small cell lung cancer (Poster Board: #430b; Abstract TPS9111)

• Poster Session Title: Lung Cancer--Non-Small Cell Metastatic
• Presentation Date & Time: Sunday, June 03, 8:00 AM - 11:30 AM CT
• Location: Exhibit Hall A, McCormick Place Convention Center

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.

In April, Lycera reported results from the completed Phase 1 portion of the ARGON study demonstrating that LYC-55716 was well-tolerated by patients. Further, of 26 patients evaluable for response in the dose escalation portion of the study, 12 (46%) had stable disease (SD), including 7 patients (27%) with disease stabilization exceeding 4 months. One patient has a confirmed partial response (cPR) and is 1 of 3 patients that remain on study. More of the reported results from the study are available at this link.

About the LYC-55716 Phase 1b Combination Trial

Initiated in January 2018, 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 for biomarker evaluation. 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.

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. LYC-55716 is an investigational compound that is not approved for any use in any country.

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 developing a wholly owned, oral, gut-directed ATPase modulator, designated LYC-30937-EC, for the treatment of autoimmune disease. 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.

Trademark

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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