On November 16, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the company has received a Study May Proceed Letter from the United States Food and Drug Administration (FDA) to begin a Phase 1 trial, named INNATE, for JTX-8064 (Press release, Jounce Therapeutics, NOV 16, 2020, View Source [SID1234571126]). JTX-8064 is an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) antibody and is the first tumor-associated macrophage candidate from Jounce’s Translational Science Platform. Through the Study May Proceed Letter, the FDA has cleared the original Investigational New Drug (IND) application for JTX-8064. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.
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The Phase 1 INNATE trial will consist of 4 parts:
JTX-8064 monotherapy dose escalation in solid tumors
JTX-8064 dose escalation in combination with Jounce’s PD-1 inhibitor, JTX-4014, or with pembrolizumab in solid tumors
JTX-8064 monotherapy in indication-specific expansion cohorts
JTX-8064 + JTX-4014 or pembrolizumab in indication-specific expansion cohorts
"Our INNATE trial represents the first time we are combining two wholly owned Jounce immunotherapies targeting two different immune cells in the tumor microenvironment," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "We believe that targeting multiple immune cell types including immunosuppressive macrophages in the tumor microenvironment may offer new promise for patients, particularly those with PD-(L)1 inhibitor resistant tumors, where IO therapies have yet to make a substantial impact. Expansion cohorts in INNATE will include PD-(L)1 resistant and sensitive tumor types, and PD-(L)1 naïve and experienced patients. INNATE is designed to advance rapidly to initiation of indication-specific JTX-8064 monotherapy and PD-1 inhibitor combination expansion cohorts, with a goal to establish proof-of-concept as quickly as possible, and we are on track to begin enrollment in INNATE by the end of the year."
About JTX-8064
JTX-8064 is a humanized anti-LILRB2 (ILT4) antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with a PD-1 inhibitor is planned to begin enrollment by year-end 2020.
About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. JTX-4014 demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, JTX-4014 was shown to have an acceptable safety profile. JTX-4014 is currently being assessed in the SELECT Phase 2 clinical trial in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. The SELECT trial compares vopratelimab plus JTX-4014 to JTX-4014 alone in immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor.