Jounce Therapeutics’ JTX-2011 was well-tolerated by patients with advanced solid tumors in the Phase 1/2 ICONIC clinical trial (NCT02904226), alone or in combination with Opdivo (nivolumab), supporting advancement of the study to the Phase 2 stage.
Results of the Phase 1 portion of the trial were presented at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting earlier this month. The poster was titled “Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.”
JTX-2011 is a monoclonal antibody that targets a protein called ICOS (Inducible CO-Stimulator of T cells). JTX-2011 is thought to both stimulate immune cells involved in fighting tumors, and to reduce the numbers of immune cells that suppress the anti-tumor response within tumors.
The Phase 1 portion of the trial was designed to establish the safety and tolerability of JTX-2011 and to determine the recommended Phase 2 dose of JTX-2011, when used alone or in combination with Opdivo. The patients included had advanced solid tumors that had not responded to all available therapies. Tumor types included endometrial, triple negative breast, melanoma, lung, pancreatic, and colorectal cancers.
Most adverse events attributed to JTX-2011 were mild to moderate and involved chills, decreased appetite, dizziness, neck pain, nausea, and fever.
The initiation of the Phase 2 portion of the ICONIC trial was announced in April, and consists of two parts (C and D) to evaluate preliminary efficacy. The enrollment of patients in part C of the trial, studying JTX-2011 monotherapy, is currently underway.
“We are very encouraged by the safety and pharmacodynamic data from the ICONIC study, which showed JTX-2011 to be well-tolerated as a monotherapy and in combination with nivolumab,” Beth Trehu, MD, chief medical officer of Jounce Therapeutics, said in a press release. “The JTX-2011 Phase 1 data in this poster is the first clinical data to be presented with an ICOS agonist antibody, and includes the safety, PK and PD data, as well as the selected dose for the Phase 2 monotherapy portion of the trial that was initiated in April of this year.”
“These early data are promising and support our advancement to the Phase 2 portion of the ICONIC study,” said Richard Murray, PhD, CEO of Jounce Therapeutics. “As we shift our focus to look at measures of preliminary efficacy, we will be utilizing the biomarker enrichment strategy that defines Jounce’s translational approach, and enroll a certain number of patients with a high percentage of ICOS-expressing immune cells in their tumors into the Phase 2 cohorts. We look forward to gaining important insights on how JTX-2011 may benefit patients that have not had success with currently available therapies,”