Lycera Corp., a biopharmaceutical company developing breakthrough oral immune modulators to treat autoimmune disease and cancer, announced that data on the anti-tumour activity of the company’s novel synthetic ROR? agonist product candidates were presented at the Society for Immunotherapy of Cancer (SITC) annual meeting being held in National Harbor, Md. Results presented in a poster presentation entitled "Novel synthetic ROR? agonist compounds as a potential anti-tumour therapeutic approach."

The research findings demonstrate that ROR? agonists reprogramme immune cells to enhance their activity and survival as well as decrease immunosuppressive mechanisms in the tumour that can limit the efficacy of cancer immunotherapies. Collectively, these activities result in decreased tumour growth and significantly enhanced survival in animal models of cancer. As a result, researchers conclude modulation of the immune system by ROR? agonists may provide significant anti-tumour benefits in treatment of a range of cancers.

"While research involving immune-oncology approaches to treat cancer is expected to have a substantial impact in the years ahead, most agents in development are biologics with single mechanisms of action,” said Gary Glick, Ph.D., founder and chief scientific officer, Lycera Corp., adding, “Lycera’s proprietary and wholly owned program based on ROR? agonists represents a completely new approach that is shown to have multiple anti-cancer mechanisms."

According to the study results, ROR? small molecule agonists effectively increase immune activation mechanisms, such as enhanced cytokine production from murine and human cells. They also decrease immune suppression mechanisms as demonstrated by favorable changes in T-effector to T-reg cell ratios and by reduced PD-1 expression and cell desensitization to checkpoint inhibition. Highlighting potential utility in adoptive cell therapy systems, enhanced tumour growth control is observed following the addition of ROR? agonists to T cell expansion cocktails. Recent research has further shown that oral delivery of ROR? agonists exhibit single agent activity with a demonstrated increase in survival in the MC38 colon cancer model. As a result, oral ROR? agonists as monotherapy may have the potential to inhibit tumour growth and increase long term survival.

"High potency, orally available compounds are rapidly advancing at Lycera and are showing promise as a cancer immunotherapy approach. This important research provides significant additional confirmation of their potential benefits in both mono and combination therapy," said Dr. Glick. "We look forward to continuing our efforts to advance this important research platform at Lycera."

ROR? is a nuclear receptor transcription factor that drives the activation and differentiation of immune cells including Th17 (helper T-cells) and Tc17 (cytotoxic) T cells. These polyfunctional cells boost the immune response to cancer cells both by direct immune system activation as well as by decreasing immune suppression. Selective agonists have been shown to activate multiple anti-tumour mechanisms, resulting in increased immune function, durable tumour killing activity, decreases in checkpoint pathways and decreases in regulatory immune cells. Lycera has developed potent, oral ROR? agonists that demonstrate anti-cancer activity in animal models. ROR? agonists represent a potential new class of immune therapy either as individual therapy or in combination with standard of care approaches in cancer.

Lycera is a privately held biopharmaceutical company that seeks to uncover new small molecule therapies for the treatment of autoimmune diseases and cancer.