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Lycera Announces Research Showing Novel, Oral Immunotherapy Possesses Potent Single Agent Anti-Cancer Activity

ANN ARBOR, Mich., Nov. 7, 2014 /PRNewswire/ -- Lycera Corp., a biopharmaceutical company developing breakthrough oral immune modulators to treat autoimmune disease and cancer, today announced that data on the anti-tumor activity of the company's novel synthetic RORgamma agonist product candidates were presented at the Society for Immunotherapy of Cancer (SITC) annual meeting being held in National Harbor, MD. Results were presented in a poster presentation entitled "Novel synthetic RORgamma agonist compounds as a potential anti-tumor therapeutic approach" and will be highlighted in an oral presentation on Saturday, November 8, at 1:40 PM.

The research findings demonstrate that RORgamma agonists reprogram immune cells to enhance their activity and survival as well as decrease immunosuppressive mechanisms in the tumor that can limit the efficacy of cancer immunotherapies. Collectively, these activities result in decreased tumor growth and significantly enhanced survival in animal models of cancer. As a result, researchers conclude modulation of the immune system by RORgamma agonists may provide significant anti-tumor 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 RORgamma agonists represents a completely new approach that is shown to have multiple anti-cancer mechanisms."

According to the study results, RORgamma 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 effector T cell to Treg cell ratios and by reduced PD-1 expression and cell desensitization to checkpoint inhibition. Highlighting potential utility in adoptive cell therapy systems, enhanced tumor growth control is observed following the addition of RORgamma agonists to T cell expansion cocktails. Recent research has further shown that oral delivery of RORgamma agonists exhibits single agent activity with a demonstrated increase in survival in the MC38 colon cancer model. As a result, oral RORgamma agonists as monotherapy may have the potential to inhibit tumor 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."

About RORgamma agonists

RORgamma 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-tumor mechanisms, resulting in increased immune function, durable tumor killing activity, decreases in checkpoint pathways and decreases in regulatory immune cells. Lycera has developed potent, oral RORgamma agonists that demonstrate anti-cancer activity in animal models. RORgamma agonists represent a potential new class of immune therapy either as individual therapy or in combination with standard of care approaches in cancer.

About Lycera

Lycera is a privately held biopharmaceutical company that seeks to uncover new small molecule therapies for the treatment of autoimmune diseases and cancer. Our approach builds on an in depth understanding of the orchestration of immune response in disease progression.

Lycera product development programs are enhanced by our established global relationships with many leading chemists, scientists, biologists and clinical researchers. We are currently advancing novel small molecule compounds from distinct, yet complementary, areas of research, including immune metabolism, cell signaling and immune cell differentiation. In addition to a robust proprietary pipeline, the company has an established research collaboration with Merck to discover, develop and commercialize small-molecule therapies for autoimmune disorders.

Bill Berry
Berry & Company Public Relations
212 253 8881

SOURCE Lycera Corp.
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