Jounce Therapeutics to Present Safety and Preliminary Efficacy Data on JTX-4014 and a Trials in Progress Poster for the Vopratelimab EMERGE Study at the Society for Immunotherapy of Cancer’s (SITC) 34th Annual Meeting
- Recommended Phase 2 dose determined for future JTX-4014 trials -
- Introducing the dosing and sequencing strategy for vopratelimab and ipilimumab in ongoing EMERGE Phase 2 trial -
“Our poster sessions at this year’s
Poster Presentation Details:
Title: Phase 1 First in Human Study of Programmed Cell Death Receptor-1(PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
Presentation Date and Time:
Abstract ID: P439
Jounce researchers describe the safety, preliminary efficacy and recommended Phase 2 doses for JTX-4014 including:
- Acceptable safety profile for JTX-4014 based on a 6-cohort dose-escalation trial. There were no deaths or dose limiting toxicities, few Grade 3/4 adverse events and the only related serious adverse event (SAE) was pneumonitis, which occurred after the second dose at 1200 mg Q3W.
- Antitumor activity observed with an overall response rate of 16.7% (3/18), including 1 complete response and 2 partial responses (confirmed) in a difficult to treat population with no therapeutic options.
- The disease control rate was 44.4% (8/18).
- Typical IgG4 profile with linear pharmacokinetics (PK).
- Planned Phase 2 studies utilizing recommended doses of either 500mg Q3W or 1000mg Q6W.
Title: Phase 2 Multicenter Trial of ICOS Agonist Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects with Non-Small Cell Lung Cancer or Urothelial Cancer (EMERGE)
Presentation Date and Time:
Abstract ID: P438
Jounce researchers highlight the scientific rationale for the ongoing Phase 2 EMERGE trial including:
- Based on reverse translational findings from the ICONIC trial, strategies to optimize emergence and expansion of
ICOShi CD4 T cells have become a cornerstone of the vopratelimab development program.
- The sequence of administration of ipilimumab and vopratelimab combination in EMERGE is designed to induce
ICOShi CD4 T cells with ipilimumab followed by their expansion and sustained activation by vopratelimab.
- A pulsed dose and schedule for vopratelimab, designed to optimize agonist antibody activity, is explored. Specifically, the trial evaluates two different vopratelimab dose levels and a new dosing interval.
Both posters will be available on the “Our Pipeline” section of the
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates. Jounce completed enrollment in the Phase 1 clinical trial of JTX-4014 and additional studies with JTX-4014 and our other product candidates are planned.
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 clinical trial 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 “will,” “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; 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
The Yates Network
Source: Jounce Therapeutics, Inc.