Within the oncology treatment community, there is a rapidly expanding focus on how to mobilize the immune system and simultaneously reduce immunosuppression to drive anti-tumor immune responses. Checkpoint inhibitors, including anti-PD-(L)1 and anti-CTLA-4 antibodies, have demonstrated the promise of cancer immunotherapy. However, durable responses have only been seen in a subset of patients. Currently, new cancer approaches are focusing on increasing the activation and persistence of effector immune cells (T-effector cells), as well as ameliorating immunosuppressive mechanisms (e.g., T-reg cells). Based on deep experience in immune activation and immune suppression mechanisms.

Lycera is developing a first-in-class, oral immunotherapy for the treatment of cancer. LYC-55716 is an RORγ agonist 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. 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, or Gastroesophageal Cancer. In January of 2018, Lycera announced the initiation of a Phase 1B combination study in metastatic Non-small Cell Lung Cancer in combination with pembrolizumab.