Lycera’s mission is to develop new classes of oral immune modulators that can selectively suppress or activate the immune system, with the potential to transform the treatment of serious immune-related diseases often reliant on the use of injectable agents. Lycera has built a world-class R&D engine leveraging our expertise in immunology, metabolism and chemistry to generate a portfolio of highly promising drug targets based on compelling science and prevailing medical need. Our approach is supported by a culture of scientific excellence, adaptability, and collaborative working relationships with premier researchers worldwide. Our goal is to advance products that promise substantial advances in treatment, not simply incremental gains.
Extensive clinical research confirms that autoimmune disease is caused by the aberrant activation and control of immune effector cells attacking the patient’s own tissues. Lycera has engineered a first-in-class, gut-directed ATPase modulator, LYC-30937, which is designed to induce selective cell death (apoptosis) of only disease-causing immune cells. The Company completed Phase 1 clinical testing of LYC-30937-EC in healthy volunteers in December 2015. In 2016, Lycera announced the initiation of two Phase 2 clinical trials for LYC-30937-EC, the first study in patients with ulcerative colitis (UC) and the second study in patients with moderate psoriasis. (Please click here for more information)
In contrast to autoimmune diseases, in many types of cancers, disease progression is correlated with insufficient immune activity. Tumors invoke a number of mechanisms to evade, suppress, or counteract the activity of immune cells. The Company’s lead immuno-oncology program, an RORγ agonist, LYC-55716, is designed to activate immune cell responses to tumor cells and has demonstrated significant tumor growth inhibition and improved survival in preclinical cancer models. 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. In October 2017, Lycera announced that LYC-55716 was advancing to Phase 2A development. The Phase 2A expansion is expected to enroll approximately 75 patients in 6 tumor cohorts. Tumor cohorts were identified based on RORγ expression, biology and sensitivity to immunotherapies. In January of 2018, Lycera announced the initiation of a Phase 1B combination study with pembrolizumab in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). (Please click here for more information)