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., Oct. 10, 2018 /PRNewswire/ — Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced that two abstracts highlighting data from ongoing clinical studies of the company’s novel immuno-oncology therapeutic candidate, LYC-55716, will be presented as posters during the 2018 European Society for Medical Oncology (ESMO) Congress, being held Oct. 19-23, 2018, in Munich, Germany. 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: RORgamma agonist LYC-55716 in combination with pembrolizumab to treat metastatic non–small cell lung cancer: an open-label, multicenter Phase 1b trial

  • Poster Display Session Title: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
  • Date & Time (Poster Only): 20, 2018 at 12:30 p.m. CEST
  • Poster Number: 1169P
  • Location: Hall A3 – Poster Area Networking Hub, ICM München, Munich, Germany

Abstract Title: Novel Small-Molecule RORgamma Agonist Immuno-oncology Agent LYC-55716: Safety and Efficacy in a Phase 2A Open-Label, Multicenter Trial

  • Poster Discussion Session Title: Immuno 2
  • Poster Discussion Date and Time: 22, 2018 at 9:55 a.m. CEST
  • Poster Number: 1139PD
  • Location: Hall B3 – Room 21, ICM München, Munich, Germany

 

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 June, Lycera updated the reported results from the completed Phase 1 portion of the ARGON study demonstrating that LYC-55716 was well-tolerated by patients. Further, of 25 patients evaluable for response in the dose escalation portion of the study, two patients had confirmed partial responses (NSCLC and sarcomatoid breast cancer), 11 (44%) had stable disease (SD), including six patients (24%) with disease stabilization exceeding four months. More of the reported results from the study are available here.

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 its world-class R&D engine, Lycera is advancing clinical candidates from distinct, yet complementary, areas of research, including immune metabolism, cell signaling, and immune cell differentiation. The Company has a leading position in the development of agonists of RORgamma, a master transcription factor, or “master control switch,” with diverse applications in immuno-oncology. LYC-55716, a first-in-class 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 with pembrolizumab in patients with advanced non-small cell lung cancer.

Lycera has also developed, novel ATPase modulators, for the treatment of autoimmune disease. ATPase modulators have been shown to be beneficial in several widely-accepted models for autoimmune disease, as well as in human translational systems, acting through pathways directly involved in immune regulation.

In 2015, Celgene entered into an exclusive license for Lycera’s portfolio of novel RORgamma agonist compounds for use ex-vivo, and in 2017 Lycera granted an exclusive license for RORgamma antagonist compounds.

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: Nancie Steinberg, Burns McClellan, 212-213-0006, ext. 318, nsteinberg@burnsmc.com