Preliminary Findings from Phase 1/2a Trial Demonstrate LYC-55716 Was Well-Tolerated

Durable Disease Stabilization Observed in Heavily Pretreated Patients

NEW YORK and ANN ARBOR, Mich., September 11, 2017 /PRNewswire/ — Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, announced today the first presentation of clinical findings from the initial three cohorts of patients (N=15) in Lycera’s Phase 1/2a ARGON study of its novel immuno-oncology therapeutic candidate, RORgamma agonist LYC-55716. The Phase 1 portion of the trial is expected to enroll a total of approximately 25 patients with advanced, relapsed, or refractory solid tumors. In the first three cohorts, LYC-55716 has been well-tolerated in patients, 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 remain on treatment at the time of the presentation. These and additional results from the Phase 1/2a study were presented yesterday at the European Society for Medical Oncology (ESMO) Congress, which is being held in partnership with the European Association for Cancer Research (EACR) in Madrid, Spain, September 8-12, 2017.

“We are very encouraged by the early safety findings observed in the initial three cohorts as well as the disease stabilization in some of these heavily pretreated patients,” said H. Jeffrey Wilkins, M.D., Lycera’s chief medical officer. “In preclinical studies, LYC-55716 was shown to simultaneously enhance the activity of T lymphocyte immune cells while decreasing immunosuppression. We believe our compound’s unique ability to reprogram the immune response, which we hope to confirm in clinical testing, holds great promise in broadening the benefits of immunotherapy for cancer patients.”

“We are pleased to announce the presentation of our first clinical trial results in immune-oncology, exemplifying the rapid progress of Lycera’s broad clinical pipeline advancing novel oral immune modulating therapies,” said Paul Sekhri, President and CEO of Lycera. “We look forward to the continued progress of our Phase 1/2a study, which we anticipate to be fully enrolled by mid-2018. Our teams also continue to advance our lead program for LYC-30937-EC (Enteric Coated), our first-in-class, oral, gut-directed ATPase modulator, for patients with ulcerative colitis and moderate psoriasis, respectively.”

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 (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 RECIST v1.1 criteria. Upon determination of the recommend Phase 2a dose, LYC-55716 will enter Phase 2a, which is expected to enroll approximately 70 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.


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