Lycera Announces Publication of Immuno-Oncology Research, Demonstrating Differentiated Mechanism of RORgamma Agonists

NEW YORK and ANN ARBOR, Mich., Nov. 4, 2016 /PRNewswire/ -- Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, announced today the publication of new research findings for the Company's most advanced cancer immunotherapy program: oral, selective RORgamma agonists.  RORgamma is a nuclear receptor transcription factor that serves as a master control switch of the immune system, driving the generation and function of Type 17 effector immune cells, Th17 (helper), and Tc17 (cytotoxic) T cells.  These Type 17 immune T cells play an important role in mediating anti-tumor immune responses.

In an article titled, "Synthetic RORgamma agonists regulate multiple pathways to enhance anti-tumor immunity," appearing in OncoImmunology, a research team, including scientists at Lycera, the Medical University of South Carolina, and the University of Michigan, report key preclinical research findings from Lycera's program, including:

• RORgamma expressing T cells infiltrate a range of human tumors.
• RORgamma agonists enhance immune cell effector functions such as cytokine production and cytotoxic activity, while also improving the persistence or survival of Type 17 T cells.
• The agonists inhibit the formation of regulatory T cells, which can suppress immune activity. This results in a favorable shift in the ratio of effector to suppressor T cells.
• Treatment of Type 17 cells with RORgamma agonists promotes T cell activation by mediating both an increase in expression of co-stimulatory molecules, including CD226, CD27, and 4-1BB (CD137), and a concomitant decrease of co-inhibitory molecule expression, including PD-1, TIGIT, TIM3, CD73, and LAG3.
• Treatment of T cells ex vivo with RORgamma agonists enhances the anti-tumor activity and persistence of anti-tumor effector T-cells in models of adoptive cell therapy.
• Oral administration of Lycera's RORgamma agonists have demonstrated single agent activity in multiple syngeneic tumor models, resulting in immune-dependent inhibition of tumor growth and extended survival.

"We are pleased to report the publication of promising results for our RORgamma agonist program, highlighting the multiple anti-tumor mechanisms elicited by a single selective compound," said Paul Sekhri, President and CEO of Lycera. "By targeting the RORgamma transcription factor, Lycera's novel oral agents have been shown to reprogram the immune system to both increase the activity of anti-tumor immune cells, as well as reduce immunosuppressive mechanisms resulting in single agent anti-tumor activity in preclinical models. These findings provide a strong rationale for the potential of our lead program in immune-oncology, and we look forward to the continued advancement of this program to clinical trials."

The article citation is: Hu X, Liu X, Moisan J, Wang Y, Lesch CA, Spooner C, Morgan RW, Zawidzka EM, Mertz D, Bousley D, Majchrzak K, Kryczek I, Taylor C, Van Huis C, Skalitzky D, Hurd A, Aicher TD, Toogood PL, Glick GD, Paulos CM, Zou W, Carter LL. Synthetic RORg agonists regulate multiple pathways to enhance anti-tumor immunity. OncoImmunology. 2016. [Epub ahead of print]. doi: 10.1080/2162402X.2016.1254854

About RORgamma agonists

RORgamma is a nuclear receptor transcription factor that serves as a master control switch of the immune system, driving the activation and differentiation of immune cells, including Th17 (helper T-cells) and Tc17 (cytotoxic T cells) T cells. Lycera has discovered selective and potent oral agonists that target RORgamma which are advancing to the clinic for the potential treatment of a broad range of cancers. These RORgamma agonists have demonstrated single agent therapeutic activity in multiple animal models of cancer. In addition, ex vivo treatment with Lycera's RORgamma agonist compounds has been shown to enhance the therapeutic benefit of adoptive T-cell therapy by improving both immune cell persistence and activation.

About Lycera

Lycera is a biopharmaceutical company developing novel oral immune modulators for the treatment of autoimmune diseases and cancer. Based on successful progress of its world-class R&D platform, including expertise in immune metabolism, cell signaling, and immune cell differentiation, Lycera is commencing multiple clinical programs in 2016. The company is advancing a wholly owned, oral, gut-directed ATPase modulator, designated LYC-30937-EC, for the treatment of autoimmune disease, and has entered Phase 2 clinical studies in patients with ulcerative colitis. The Company also is progressing oral RORgamma agonists for diverse applications in immuno-oncology. Lycera has an exclusive strategic collaboration with Celgene Corporation to advance Lycera's proprietary pipeline for cancer and immune-mediated diseases. In addition, Lycera had previously established collaborations with Merck to discover, develop, and commercialize small molecule therapies for autoimmune disorders.

Lycera's leadership possesses deep experience in drug discovery, development, and commercialization and has established close relationships with renowned thought leaders and clinical researchers worldwide. Lycera was founded in 2006 based on an initial scientific platform in-licensed from the University of Michigan. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures, and EDF Ventures.

CONTACT: Justin Jackson, Burns McClellan, 212-213-0006, ext. 327, [email protected]

SOURCE Lycera Corp.

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