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Lycera’s research shows promising anti-cancer activity of new, oral Immunotherapy candidates

Lycera, a biopharmaceutical company developing breakthrough medicines to treat cancer and autoimmune disease, announced that promising data for the anti-tumor activity of the company's oral, selective RORgamma agonist product candidates were presented at the 2015 Keystone Symposia Conference – Tumor Immunology: Multidisciplinary Science Driving Combination Therapy – being held in Banff, Alberta, Canada.

The results are highlighted today in a poster presentation titled, "Novel oral RORgamma agonists demonstrate anti-tumor efficacy in the 4T1 breast cancer model," with lead author, Jacques Moisan, Ph.D., Lycera’s Associate Director, Biology.

The research findings demonstrated that Lycera’s RORgamma agonists were able to reprogram T cells to enhance their activity and survival, including enabling them to resist immunosuppressive mechanisms in tumors that can limit the efficacy of cancer immunotherapy.

Single agent use of RORgamma agonists in an in vivo preclinical model significantly decreased growth of 4T1 mammary carcinoma, a cancer frequently resistant to immunotherapy. In addition, effectiveness of adoptive cell therapy in another preclinical model increased in the presence of RORgamma agonism.

Based on these and related preclinical findings, the researchers concluded that "RORgamma agonist molecules combine multiple anti-tumor activities into a single therapeutic."

Gary Glick, Ph.D., Lycera’s founder and Chief Scientific Officer, commented, "We are very pleased with the growing recognition of our program advancing small molecule RORgamma agonists that are designed to both decrease immune suppression, as with checkpoint inhibitors, as well as increase immune activity.

"In addition to demonstrating an ability to help mediate potent, durable anti-tumor responses, the currently reported research also showed that Lycera’s RORgamma agonists have drug-like oral pharmacokinetic properties, as well as the ability to stimulate differentiation of multiple classes of T cells with key roles in targeting and attacking tumors. I look forward to the continued, successful progress of this program."

Lycera’s President and Chief Executive Officer Paul Sekhri stated, "Lycera’s teams, possessing world-class immunology research experience, have achieved rapid progress in the Company’s RORgamma agonism program, which is expected to enter IND-enabling studies this quarter. Based on this momentum, we are targeting first-in-man clinical studies of this novel and promising approach to immuno-oncology by the end of 2015."

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 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 a stand-alone agent or in combination with standard of care approaches.