Lycera to Present Clinical Results and Supporting Preclinical Data for First-In-Class RORgamma Agonist LYC-55716 at the 2018 AACR Annual Meeting

Thursday, April 5, 2018 Clinical Trials News
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LYC-55716 Currently Advancing in Phase 2a Portion of ARGON Study and in Phase 1b Combination Trial with Pembrolizumab

NEW YORK and ANN ARBOR, Mich., April 5, 2018 /PRNewswire/ -- Lycera Corp., a privately

held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced that the Company will present new clinical and preclinical findings from its cancer immunotherapy program at the 2018 American Association of Cancer Research (AACR) Annual Meeting, being held April 14-18, 2018, at the McCormick Place Convention Center, Chicago, Illinois. In five abstracts accepted for poster presentation, Lycera will report safety and dose selection results for the company's novel therapeutic candidate, LYC-55716, a ROR?t (RORgamma) agonist, as well as preclinical data supporting use of this candidate in combination therapy. LYC-55716 is a first-in-class oral, selective retinoic acid-related orphan receptor-gamma (RORgamma) agonist designed to reprogram the immune system in patients with solid tumors.

"Acting as a master switch for driving differentiation of immune cells known as Type 17 T cells, RORgamma has been shown to play a critical role in augmenting cancer immunotherapy approaches," said Samir N. Khleif, MD, BioMedical Scholar and Professor of Oncology and Director, The Loop Immuno-Oncology Laboratory, Lombardi Cancer Center, Georgetown University Medical Center, and lead investigator for preclinical research on combination approaches with RORgamma agonists being presented at AACR this month. "At AACR, we will report, in depth, that RORgamma agonism significantly bolsters anti-PD1 anti-tumor effect and improves anti-OX40 tumor control. These promising findings provide additional support for ongoing clinical studies of combination therapy with LYC-55716."

"In addition to these important preclinical results, we are excited to present the first clinical results from Lycera's RORgamma agonist program at one of the most important cancer meetings of the year," said Paul Sekhri, President and CEO of Lycera. "At Lycera, we are advancing multiple programs to assess the clinical efficacy of LYC-55716 both as a monotherapy in multiple tumor types, as well as in combination with pembrolizumab (KEYTRUDAŽ) in advanced non-small cell lung cancer (NSCLC). For our ARGON study, we anticipate completing patient enrollment in the Phase 2a portion by mid-2018, with the expectation of reporting topline efficacy results in the first half of 2019. In addition, based on current progress, we expect our Phase 1b study assessing combination therapy with LYC-55716 and pembrolizumab will be able to report early safety and efficacy data in the middle of 2019. We are proud of this progress and are grateful to our talented R&D teams and the clinicians, researchers, and patients participating in our clinical trials program."

Details for the poster presentations are as follows:

Abstract Title: Safety and dose selection for LYC-55716, a first-in-class ROR? agonist to treat solid tumors: Phase I results from an open-label, multicenter Phase I/IIa trial (Abstract CT132 / Poster 15)

  • Poster Session Title: Phase I Trials in Progress
  • Presentation Date & Time: Tuesday, April 17, 2018, 8:00 AM - 12:00 PM CT
  • Location: Poster Section 42, Exhibit Hall A, McCormick Place South

Abstract Title: Novel ROR?t agonist induces antitumor immune effect through enhancement of tumor antigen-specific CD8+ T-cell infiltration into the TME (Abstract 3762 / Poster 12)

  • Poster Session Title: Immunomodulatory Agents and Interventions 1
  • Presentation Date & Time: Tuesday, April 17, 2018, 8:00 AM - 12:00 PM CT
  • Location: Poster Section 32, Exhibit Hall A, McCormick Place South

Abstract Title: ROR? agonist enhances antitumor effects of agonist anti-OX40 antibody (Abstract 3773 / Poster 23)

  • Poster Session Title: Immunomodulatory Agents and Interventions 1
  • Presentation Date & Time: Tuesday, April 17, 2018, 8:00 AM - 12:00 PM CT
  • Location: Poster Section 32, Exhibit Hall A, McCormick Place South

Abstract Title: ROR? agonist enhances antitumor effects of immune checkpoint anti-PD1 (Abstract 3777 / Poster 27)

  • Poster Session Title: Immunomodulatory Agents and Interventions 1
  • Presentation Date & Time: Tuesday, April 17, 2018, 8:00 AM - 12:00 PM CT
  • Location: Poster Section 32, Exhibit Hall A, McCormick Place South

Abstract Title: LYC-55716, a first-in-class ROR? agonist: Rationale and preclinical data to support clinical combinations with established immunotherapies (Abstract 5566 / Poster 22)

  • Poster Session Title: Immunomodulatory Agents and Interventions 3
  • Presentation Date & Time: Wednesday, April 18, 2018, 8:00 AM - 12:00 PM CT
  • Location: Poster Section 25, Exhibit Hall A, McCormick Place South

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 commenced 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 and psoriasis. A second product candidate, LYC-55716, an oral RORgamma agonist, is progressing in the Phase 1/2a ARGON trial, a monotherapy study in patients with advanced solid tumors, as well as in a Phase 1b combination trial. Lycera has an exclusive strategic collaboration with Celgene Corporation to advance Lycera's proprietary pipeline for cancer and immune-mediated diseases.

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.

Trademarks

KEYTRUDAŽ is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

CONTACT: Justin Jackson, Burns McClellan, 212-213-0006, ext. 327, jjackson@burnsmc.com

 

Cision View original content:http://www.prnewswire.com/news-releases/lycera-to-present-clinical-results-and-supporting-preclinical-data-for-first-in-class-rorgamma-agonist-lyc-55716-at-the-2018-aacr-annual-meeting-300624445.html

SOURCE Lycera Corp.

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