Selective RORγ agonist product candidates demonstrated activity as single agent therapy

NEW YORK, NY; ANN ARBOR, Mich. – February 9, 2015Lycera Corp., a biopharmaceutical company developing breakthrough medicines to treat cancer and autoimmune disease, today announced that promising data for the anti-tumor activity of the company’s oral, selective RORγ (“ROR gamma”) 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 RORγ 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 RORγ 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 RORγ 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 RORγ agonism. Based on these and related preclinical findings, the researchers concluded that “RORγ 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 RORγ 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 RORγ 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 RORγ 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.”

 

About RORγ agonists

RORγ 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 RORγ agonists that demonstrate anti-cancer activity in animal models. RORγ agonists represent a potential new class of immune therapy either as a stand-alone agent or in combination with standard of care approaches.

 

About Lycera

Lycera is a biopharmaceutical company advancing novel treatments for cancer and autoimmune diseases based on a proprietary portfolio of small molecules designed primarily to either suppress or activate the immune response. The Company’s world-class expertise in distinct, yet complementary, areas of research – immune metabolism, cell signaling and immune cell differentiation – has generated four wholly owned programs, including a lead product candidate to treat inflammatory bowel disease (LYC-30937) expected to enter clinical testing in the first half of 2015. In addition, Lycera has established two collaborations with partner Merck to discover, develop and commercialize small molecule therapies for autoimmune disorders. The Lycera leadership team possesses deep experience from drug discovery and development through commercialization and has established close relationships with renowned thought leaders and clinical researchers worldwide. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures and EDF Ventures.