Jounce Therapeutics Initiates Phase 1/2 ICONIC Study of JTX-2011 in Patients with Advanced Solid Tumors

CAMBRIDGE, Mass., Sept. 07, 2016 -- Jounce Therapeutics, Inc., a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced enrollment of the first patients in ICONIC, the Company’s Phase 1/2 clinical trial evaluating its lead product candidate, JTX-2011. The trial is currently enrolling patients with advanced solid tumors who have not responded to standard treatment options or whose cancers have returned following standard treatment.

“JTX-2011 is the first clinical program to emerge from our Translational Science Platform, which couples the choice of target mechanism to potential predictive biomarkers of response, and represents a key milestone for Jounce. JTX-2011 is a monoclonal antibody targeting the ICOS receptor that is designed to both stimulate T effector cells and reduce T regulatory cells in tumors, thus shifting the balance of the tumor microenvironment from immunosuppressive towards anti-tumor activity. With this study underway, we are excited to gain important clinical insights on how the unique mechanism of JTX-2011 may benefit patients that have not had success with current standard of care therapies,” said Beth Trehu, M.D., FACP, chief medical officer of Jounce.

The ICONIC trial (ICOS AgONist Antibody for Immunotherapy in Cancer Patients), with its four-part, adaptive design, will initially assess safety and tolerability, and then preliminary efficacy of JTX-2011 as both a monotherapy and in combination with the PD-1 inhibitor nivolumab (marketed as OPDIVO^®).

The initial phase of ICONIC will be a dose-escalation study to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The second phase of ICONIC will focus on disease-specific expansion cohorts in solid tumors that the Company has identified, using its Translational Science Platform, as having the highest numbers of ICOS-expressing T cells and other ICOS-related biomarkers, an approach supported by preclinical work. Jounce plans to enroll approximately 200 patients in the ICONIC trial at 12 premier oncology sites in the U.S.

About JTX-2011
Jounce's lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells that is believed to stimulate an immune response against a patient’s cancer. JTX-2011 has a unique, dual mechanism of action, which in preclinical studies, 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.

About the Jounce Translational Science Platform
Jounce’s Translational Science Platform utilizes a suite of integrated technologies to comprehensively interrogate particular cell types within the human tumor microenvironment (the cellular environment that makes up a tumor). The platform is designed to prioritize targets and identify related biomarkers to match the right therapy to the right patients.

About Jounce Therapeutics
Jounce Therapeutics is a clinical stage immuno-oncology company dedicated to transforming the treatment of cancer. The company is discovering and developing novel cancer immunotherapies designed to harness the immune system to attack tumors and provide long-lasting benefits to patients. Jounce integrates translational science insights, including identification of related biomarkers designed to match the right immunotherapy to the right patients. The company is advancing programs that leverage contributions from its world-class founders, as well as knowledge acquired from Jounce’s Translational Science Platform, to create a sustainable “discovery to human proof-of-concept” product engine with the potential to drive significantly more durable responses to treatment. Founded by world leaders in tumor immunology, cancer biology and clinical and translational medicine, Jounce Therapeutics was launched in 2013 with funding from leading life sciences investor Third Rock Ventures. For more information, please visit www.jouncetx.com.

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Media Contact:
Dan Budwick
Pure Communications, Inc.
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Stern Investor Relations, Inc.
(212) 362-1200
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