Based on a world-class R&D engine, Lycera has built a robust proprietary pipeline of selective immune modulators for the treatment of autoimmune diseases and cancer. In August of 2016, Lycera announced the initiation of a Phase 2 randomized, placebo controlled clinical trial for LYC-30937-EC, in patients with ulcerative colitis (UC). In 2018, Lycera expects to complete the study and announce the results at a future IBD medical meeting later in the year.
Lycera completed a Phase 2 randomized, double-blind, placebo-controlled parallel group study designed to assess the efficacy and safety of LYC-30937-EC given orally once daily in subjects with moderate psoriasis.
The Company also has a leading position in the development of agonists of RORγ, a master transcription factor, or “master control switch,” with diverse applications in immuno-oncology. In January 2017, Lycera announced the initiation of a Phase 1/2A study designed to find the biologically active or maximum tolerated dose of LYC-55716. Lycera announced in October 2017 that LYC-55716 would progress to Phase 2A development. The study will enroll approximately 75 patients in 6 tumor cohorts. Tumor cohorts were identified based on RORγ expression, biology and sensitivity to immunotherapies. Patients will be enrolled if they have failed standard therapies and have been diagnosed with advanced Non-Small Cell Lung Cancer, Squamous Cell Cancer of the Head & Neck, Ovarian Cancer, Bladder Cancer, Renal Cancer, and Gastro-esophageal Cancer. The trial is expected to be fully enrolled by mid-2018.
In January 2018, Lycera announced the initiation of a multi-center Phase 1B combination study in metastatic Non-Small Cell Lung Cancer in combination with pembrolizumab.