On May 16, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that data from its ongoing Phase 1/2 ICONIC trial, an adaptive design, open label trial evaluating JTX-2011 monotherapy and in combination with nivolumab, will be the subject of an oral presentation at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5, 2018 (Press release, Jounce Therapeutics, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349498 [SID1234526705]). The abstract published today online reflects data as of January 27, 2018 and updated results will be presented on June 2, 2018.
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Jounce has met its target enrollment for the Phase 1/2 ICONIC trial in its combination cohorts across four solid tumor types: gastric cancer, triple negative breast cancer (TNBC), head and neck squamous cell cancer (HNSCC) and non-small cell lung cancer (NSCLC), with most patients completing at least one efficacy assessment. Updated results, including preliminary efficacy data on all evaluable patients in the trial, will be presented at ASCO (Free ASCO Whitepaper).
"The preliminary data from patients across multiple solid tumor types enrolled in the ICONIC trial show that JTX-2011 is well-tolerated alone and in combination with nivolumab and has demonstrated evidence of biologic activity and tumor reductions in heavily pre-treated patients who have failed all available therapies. In addition, a potential surrogate biomarker of response has been identified that may help to guide JTX-2011 development," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "We look forward to continuing clinical development of JTX-2011."
Details of the Oral Presentation
Title: ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers
Session: Developmental Therapeutics – Immunotherapy
Date and Time: Saturday, June 2, 2018, 3:00 – 3:12 p.m. CT (4:00 – 4:12 p.m. ET)
Abstract Number: 3000
Location: Hall B1
Presenter: Timothy A. Yap, MBBS, PhD, MRCP, BS, The University of Texas MD Anderson Cancer Center
Full session details and data presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.asco.org.
ASCO Abstract and Presentation
The ASCO (Free ASCO Whitepaper) abstract includes preliminary efficacy data from Phase 1 and 2 patients with gastric cancer and TNBC; pharmacodynamic data from Phase 1 that supported Phase 2 dose selection; and safety data from all Phase 2 subjects.
At the presentation, Jounce will provide longer-term follow-up from patients included in the abstract as well as preliminary efficacy data on all evaluable patients in the trial as of an April 4, 2018 cut-off date. This includes data from tumor specific cohorts in gastric cancer, TNBC, HNSCC, NSCLC and other solid tumors. Phase 1 and 2 monotherapy and combination safety data in all patients will be presented, as well as biomarker information on ICOS expression including the emergence of an ICOS high peripheral blood T cell population. Initial Phase 1 safety, PK and PD were previously reported at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting.
Jounce Therapeutics to Host Event and Webcast
Jounce Therapeutics will host an investor and analyst event beginning at 6:30 p.m. CT (7:30 pm ET) and live webcast beginning at 7:00 p.m. CT (8:00 p.m. ET), both on Monday, June 4, 2018. To access the live webcast, please visit the "Events & Presentations" page in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.
About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.