Jounce Therapeutics Presents New Vopratelimab Predictive Biomarker Data Supporting Use in the Upcoming SELECT Trial at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium Annual Meeting and Announces Research Collaboration with NanoString Technologies
- Identification of a predictive biomarker – based on an 18 gene RNA signature and vopratelimab-specific threshold (TISvopra) – for the emergence of
- Research collaboration established with
- SELECT clinical trial to be initiated in mid-2020 -
“We are excited to announce these two new developments supporting our upcoming SELECT clinical trial of vopratelimab and our own PD-1 inhibitor. The new data presented today at ASCO-SITC reveal the identification of TISvopra as a baseline predictive biomarker associated with the emergence of
Key highlights from the poster, titled “Association of a Predictive RNA Signature (RS) With Emergence of
- TISvopra is an 18 gene RNA Tumor Inflammation Signature (TIS), utilized with a vopratelimab-specific threshold and was identified as a biomarker predictive of
ICOShi CD4 T cell emergence. TISvopra positive patients treated with vopratelimab alone or in combination with nivolumab also showed improved clinical benefit (response rate, six month and nine month landmark progressive free survival and overall survival) as compared with TISvopra negative patients in the ICONIC trial.
- TIS includes genes associated with integral elements of CD4 T cell activation that may contribute to a more comprehensive immune response.
- The TISvopra threshold was chosen to optimize prediction of
ICOShi CD4 T cell emergence and was more predictive of clinical benefit than PD-L1 IHC in the ICONIC trial.
- The emergence of
ICOShi CD4 T cells is a vopratelimab, but not a PD-1 inhibitor, pharmacodynamic biomarker linked to clinical benefit in the ICONIC trial.
- In the upcoming SELECT trial, TISvopra will be used to select patients for treatment with vopratelimab and JTX-4014, Jounce’s PD-1 inhibitor.
The poster is available in the “Our Pipeline” section of the
Jounce also announced a research collaboration with
About the Phase 2 SELECT Clinical Trial
The Phase 2 SELECT clinical trial is a randomized, ex-U.S. trial to evaluate the efficacy of JTX-4014 alone and in combination with vopratelimab. The trial is powered to show statistical superiority of vopratelimab plus JTX-4014 compared to JTX-4014 alone in a biomarker-selected patient population. Jounce expects to enroll approximately 75 immunotherapy naïve second-line non-small cell lung cancer (NSCLC) patients. Patients will be prescreened for the TISvopra biomarker. Jounce estimates that approximately 20% of the prescreened NSCLC patients will be above the TISvopra threshold and potentially eligible for the trial. Jounce expects to initiate the SELECT trial in mid-2020 and report preliminary efficacy and biomarker relationships to clinical outcomes from up to 75 patients in 2021.
Jounce’s lead product candidate, vopratelimab, is a clinical-stage monoclonal antibody that binds to and activates
Cautionary Note Regarding Forward-Looking Statements
Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding the timing, progress and results of the EMERGE and SELECT clinical trials may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “expects,” “plan,” “potential” or similar terms, variations of such terms or the negative of those terms. Although Jounce believes that the expectations reflected in the forward-looking statements are reasonable, Jounce cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates; the clinical results for its product candidates, which may not support further development and marketing approval; Jounce’s ability to enroll patients in its clinical trials; the potential advantages of Jounce’s product candidates; the development plans of its product candidates and any companion or complementary diagnostics; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; and those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent Annual Report on Form 10-K filed with the
Investor and Media Contact:
Source: Jounce Therapeutics, Inc.