Jounce Therapeutics to Present Trial in Progress Posters on the Phase 1 INNATE and the Phase 2 SELECT Clinical Trials at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting

Rhea-AI Summary

Jounce Therapeutics (NASDAQ: JNCE) announced the presentation of two trial posters at the ASCO Virtual Annual Meeting from June 4-8, 2021. The Phase 1 INNATE trial poster features JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody, evaluated as both monotherapy and in combination with anti-PD-1 in advanced solid tumors. The Phase 2 SELECT trial poster examines Pimivalimab and Vopratelimab in biomarker-selected metastatic NSCLC patients. Both trials aim to assess the efficacy and safety of these novel immunotherapies in cancer treatment.

Positive

• Presentation of JTX-8064 and Pimivalimab at ASCO highlights ongoing clinical research.
• JTX-8064 shows promise in reprogramming immune-suppressive macrophages.
• Pimivalimab demonstrated a 17% durable overall response rate in prior trials.

Negative

• None.

CAMBRIDGE, Mass., April 28, 2021 (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 announced that two trial in progress posters, on the Phase 1 INNATE clinical trial and the Phase 2 SELECT clinical trial, will be presented at the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting being held June 4-8, 2021.

Poster Details:

Poster Title: Phase 1, First-in-Human trial of JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody, as monotherapy and in combination with anti-PD-1 in adult patients with advanced solid tumors (INNATE)
Presenter: Kyriakos P. Papadopoulos, MD, South Texas Accelerated Research Therapeutics (START), San Antonio, TX
Session Title: Developmental Therapeutics – Immunotherapy
Abstract Number: TPS2672
Date and Time: Friday, June 4, 2021; 9:00am ET

Poster Title: Phase 2 Study of PD-1 Inhibitor JTX-4014 (Pimivalimab) Alone and in Combination with Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects with Metastatic NSCLC After One Prior Platinum-containing Regimen (SELECT)
Presenter: Oleh Kobziev, MD, Regional Center of Oncology, Kharkiv, 61070, Ukraine
Session Title: Lung Cancer – Non-Small Cell Metastatic
Abstract Number: TPS9137
Date and Time: Friday, June 4, 2021; 9:00am ET

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s Annual Meeting and the 2019 and 2021 American Association for Cancer Research Annual Meetings support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899), of JTX-8064 as a monotherapy and in combination with either Jounce’s internal anti-PD-1 inhibitor, pimivalimab (formerly JTX-4014), or an approved anti-PD-1 inhibitor, is currently enrolling patients with advanced solid tumors.

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. The SELECT trial compares vopratelimab plus pimivalimab to pimivalimab alone in immunotherapy naïve NSCLC patients who have been pre-selected with the TIS^vopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounce’s internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial is currently enrolling approximately 75 immunotherapy naïve NSCLC patients who have been pre-selected with the TIS^vopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.

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 a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, of JTX-8064 as a monotherapy and in combination with pimivalimab (formerly JTX-4014), Jounce’s internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.

Investor and Media Contacts:
Mark Yore
Jounce Therapeutics, Inc.
+1-857-200-1255
myore@jouncetx.com

Malin Deon
Jounce Therapeutics, Inc.
+1-857-259-3843
mdeon@jouncetx.com

FAQ

What are the main findings of the JNCE trials presented at ASCO 2021?

The trials focus on JTX-8064 and Pimivalimab, demonstrating early promise in targeting tumor-associated macrophages and enhancing responses in NSCLC patients.

When will the posters about the INNATE and SELECT trials be presented?

Both trial posters will be presented on June 4, 2021, at the ASCO Virtual Annual Meeting.

What is the purpose of the INNATE Phase 1 trial for JNCE?

The INNATE trial is designed to evaluate JTX-8064's efficacy and safety as a monotherapy and in combination with PD-1 inhibitors in patients with advanced solid tumors.

What is the SELECT Phase 2 trial assessing?

The SELECT trial is assessing the combination of Pimivalimab and Vopratelimab in biomarker-selected NSCLC patients compared to Pimivalimab alone.