Press Release

Jounce Therapeutics Reports Improved PFS and OS Associated with Vopratelimab (JTX-2011) Treatment Emergent Biomarker at the 2019 American Association for Cancer Research (AACR) Annual Meeting

- Improved PFS and OS observed in patients treated with vopratelimab who have emergence of ICOS hi CD4 T cells compared to patients with ICOS lo CD4 T cells -

- ICOS hi CD4 T cells demonstrate distinct, activated T effector cell characteristics -

- Company to Host Investor Event and Live Webcast on Tuesday, April 2-

CAMBRIDGE, Mass., April 02, 2019 (GLOBE NEWSWIRE) -- Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today reported new clinical data on vopratelimab (JTX-2011) at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta, GA. The Jounce poster presentations show that patients in the ICONIC trial with emergence of ICOS hi CD4 T cells have improved progression free survival (PFS) and overall survival (OS) compared to patients with ICOS lo CD4 T cells. Data related to important immune characteristics of ICOS hi CD4 T cells were also presented.

“We are pleased to see our initial observations of tumor reductions associated with ICOS hi CD4 T cells now extend to improved PFS and OS. All observed benefit in the study was in the group of patients that showed emergence of these cells. As vopratelimab, and not PD-1 inhibitors, is responsible for the emergence of the ICOS hi CD4 cells, we are using this key translational data to guide our next steps in development,” said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. “We have further characterized the ICOS hi CD4 T cells as activated T effector cells by flow cytometry and gene expression profiling and demonstrated peripheral expansion of T cell receptor (TCR) clones originally found in the matched archival tumor. These characteristics provide additional scientific support for clinical study designs based on the emergence of ICOS hi CD4 T cells.”

In a poster titled “Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 (vopratelimab) associated biomarker (ICOS high CD4 T cells) on the ICONIC trial,” the ICONIC investigators and Jounce scientists describe the baseline characteristics and clinical outcomes of patients with emergence of ICOS hi CD4 T cells as compared to patients who did not develop this T cell population.

Three groups of ICONIC relapsed refractory solid tumor patients were compared in the new analysis: 1) 18 patients who have demonstrated ICOS hi CD4 T cells in the blood, 2) 32 patients who have demonstrated ICOS lo CD4 T cells, and 3) a group of patients enrolled in parts A through D which includes an additional 151 patients that were not tested for ICOS status due to lack of samples (“All Patients”). The analyses revealed:

  • The emergence and persistence of the ICOS hi CD4 T cell biomarker in the peripheral blood is associated with improved PFS and OS:
    • All benefit in the study, measured by tumor reductions, PFS and OS, was in the ICOS hi CD4 T cell group 
    • PFS: median 6.2 months for patients with ICOS hi CD4 T cells vs 2 months for both patients with only ICOS lo CD4 T cells and All Patients
    • OS: median not yet reached for patients with ICOS hi CD4 T cells vs 9 months for patients with only ICOS lo CD4 T cells and 9.1 months for All Patients
  • The emergence of ICOS hi CD4 T cells is attributed to vopratelimab and not PD-1 inhibitors
  • There is no association of ICOS hi CD4 T cells with the common predictive biomarkers microsatellite instability-high (MSI-H), tumor mutation burden (TMB) or PD-L1 immunohistochemistry (IHC)
  • The ICOS hi CD4 T cell group included PD-1 naive and experienced patients across multiple solid tumor types

In a poster titled “Genetic and molecular profiling of ICOS hi CD4 T cells demonstrates clonal expansion of TH1 effector cells following vopratelimab (JTX-2011) treatment in subjects with solid tumors,” Jounce researchers describe the characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment, including:

  • Vopratelimab stimulates CD4 T cells with pre-existing high levels of ICOS
  • Peripheral TCR clones associated with the original matched tumor are expanded in patients with emergent ICOS hi CD4 T cells
  • ICOS hi CD4 T cells are not T regulatory cells and display distinct characteristics of activated T effector cells by both flow cytometry and transcriptional profiling

“We are encouraged by the improved PFS and OS data associated with the emergence of the ICOS hi CD4 T cell biomarker and are convinced that meaningful advancements in immuno-oncology will require the type of science-based translational understandings that the Jounce team and platform have enabled to advance vopratelimab thus far,” said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. “We have established our translational technology base for the purpose of creating a preclinical and, more importantly, clinical scientific understanding of the mechanism of action of new immunotherapies and the characteristics of responding versus non-responding patients to focus the next steps of clinical development for vopratelimab and our pipeline.”

The posters are available on the “Our Approach” section of the Jounce Therapeutics website at www.jouncetx.com.

Jounce Therapeutics to Host Event and Webcast
Jounce Therapeutics will host an investor and analyst event beginning at 6:30 p.m. ET and live webcast beginning at 7:00 p.m. ET, on Tuesday, April 2, 2019. 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 Vopratelimab (JTX-2011)
Jounce’s lead product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO­Stimulator, a protein on the surface of certain T cells. The company is developing vopratelimab to treat solid tumors as a single agent and in combination with other therapies.

About the ICONIC Trial
The ICONIC trial is an adaptive, open label, dose escalation and expansion clinical study of vopratelimab alone and in combination with nivolumab, ipilimumab and pembrolizumab in patients with advanced solid tumors.

About Jounce Therapeutics
Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within the human tumor microenvironment to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce has three development-stage programs: its two clinical product candidates, vopratelimab, a monoclonal antibody that binds to and activates ICOS, and JTX-4014, a monoclonal antibody that binds to PD-1 and for potential use in combination with Jounce’s pipeline of future product candidates, and JTX-8064, a monoclonal antibody that binds to LILRB2 that is currently in the IND-enabling phase. For more information, please visit www.jouncetx.com.

Forward-Looking Statements
Statements in this release concerning Jounce’s future expectations and plans, including without limitation, Jounce’s expectations regarding the timing, progress and results of the clinical development of vopratelimab, and Jounce’s clinical development strategy 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 include words such as “on track,” “aims,” “anticipates,” “intend,” “may,” “potential” or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the U.S. Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Komal Joshi
Jounce Therapeutics, Inc.
(857) 320-2523
kjoshi@jouncetx.com

Media Contact:
Gina Nugent
The Yates Network
(617) 460-3579
gina@theyatesnetwork.com

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Source: Jounce Therapeutics, Inc.