Jounce Therapeutics Provides Update on INNATE Study and Discovery Pipeline Expansion, and Provides a Portfolio Update at 2021 R&D Day

Rhea-AI Summary

Jounce Therapeutics (NASDAQ: JNCE) provided an update on its clinical and discovery pipeline during its 2021 R&D Day. Notable advancements include the INNATE trial of JTX-8064, with expansion cohorts expected to begin enrollment in Q3 2021. The company introduced two new LILRB family targets, LILRB1 and LILRB4, enhancing its immunotherapy portfolio. Key presentations highlighted targeting myeloid cells in cancer treatment and the development of biomarker-enabled therapies aimed at improving patient responsiveness to existing treatments.

Positive

• Expansion cohorts for the INNATE trial of JTX-8064 expected in Q3 2021.
• Introduction of two new LILRB family targets (LILRB1 and LILRB4) enhances pipeline.

Negative

• None.

- INNATE study rapidly advancing; updates to be provided on enrollment status and receptor occupancy; expansion cohorts expected to open for enrollment in third quarter of 2021-

- Introduction of two additional LILRB family targets as potential development candidates -

- Key Opinion Leader presentation on importance of targeting the myeloid system for novel immunotherapies -

CAMBRIDGE, Mass., June 23, 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 a comprehensive update on its discovery and clinical-stage pipeline at its 2021 virtual R&D Day. Presentations will highlight Jounce’s productive discovery engine and platform, updates on its discovery pipeline, and progress on the clinical development of JTX-8064. In addition to presentations from Jounce management and scientific team members, key opinion leader and one of Jounce’s scientific founders, Robert Schreiber, Ph.D., Distinguished Professor of Pathology and Immunology at The Washington University School of Medicine, will discuss the scientific rationale for targeting myeloid cells and the therapeutic potential of re-programming macrophages through inhibition of LILRB2.

“Jounce is at an exciting time in its life cycle and I am incredibly pleased to have the opportunity to share the latest developments on our discovery and clinical stage pipelines, while also sharing a look into our productive and validated Translational Science Platform. More specifically, we will discuss the monotherapy dose escalation status of our INNATE trial of JTX-8064. Thanks to a high level of investigator engagement and dedicated efforts from our team, the timing of expansion cohort initiations is now expected in the third quarter of this year,” said Richard Murray, Ph.D., Chief Executive Officer and President of Jounce Therapeutics. “Our pipeline has been built to bring forward new biomarker-enabled immunotherapies to address the evolving unmet needs of cancer patients, whose tumors may be sensitive or resistant to today’s approved immunotherapies.”

“One of the key attributes of Jounce’s approach to immuno-oncology is its expertise in developing molecules that target a diverse set of immune cell types within the tumor microenvironment. Through the work of our platform, we have a greater understanding of how immune suppressive macrophages and LILRB2 itself can serve as negative prognostic indicators in several tumor types,” said Dmitri Wiederschain, Ph.D., Chief Scientific Officer of Jounce Therapeutics. “We believe that the LILRB family represents attractive immuno-oncology targets with the potential to improve upon and restore responsiveness to PD-(L)1 inhibitors. As such, we are pleased to announce that we are rapidly advancing two additional LILRB family programs through discovery, targeting LILRB1 and LILRB4.”

R&D Day Presentation Highlights Include:

• Utilization of Jounce’s Translational Science Platform to investigate the tumor microenvironment and identify cell type-specific targets with unique biology
• Overview of differentiated biomarker approach from discovery through development
• Introduction of new discovery programs focused on additional LILRB family members, including LILRB1 and LILRB4
• Update on monotherapy dose escalation and receptor occupancy from the INNATE clinical trial of JTX-8064
• Announcement of timing of INNATE clinical trial monotherapy and pimivalimab combination expansion cohort initiation, expected in the third quarter of 2021
• Update on continued progress on Jounce’s first biomarker patient selection study, SELECT

Anticipated Milestones:

• JTX-8064 (INNATE):
  • Establish recommended Phase 2 dose
  • Initiate tumor-specific monotherapy and pimivalimab combination expansion cohorts beginning in the third quarter of 2021
• Vopratelimab (SELECT):
  • Patient enrollment to support clinical data in 2022
• Continue to advance multiple new targets through discovery pipeline with goal of an investigational new drug (IND) every 12-18 months

Webcast Details:
A webcast of the R&D Day will be available by visiting “Events and Presentations” in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be available for 30 days following the presentation.

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, 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 obtained IND clearance for and 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.

Cautionary Note Regarding Forward-Looking Statements:
Various statements in this release concerning Jounce’s future expectations and prospects, including without limitation, Jounce’s expectations regarding the timing, initiation, progress, results and release of data for clinical trials of JTX-8064, vopratelimab and pimivalimab; establishment of a recommended Phase 2 dose for JTX-8064; the timing, progress and results of discovery programs and preclinical studies for any future product candidates; the potential benefits of any of these product candidates; our analyses and plans for data disclosures, and our plans and expectations in light of the COVID-19 pandemic, 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 “look forward”, “may” 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 and future product candidates; the preclinical and clinical results for its product candidates, which may not support further development and marketing approval; the potential advantages of Jounce’s product candidates; Jounce’s ability to successfully manage its clinical trials; 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 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 Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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

Julie Seidel
Stern Investor Relations
+1-212-362-1200
Julie.Seidel@sternir.com

FAQ

What are the recent updates from Jounce Therapeutics regarding JTX-8064?

Jounce Therapeutics announced that expansion cohorts for the INNATE trial of JTX-8064 are expected to begin enrollment in Q3 2021.

What new targets has Jounce Therapeutics introduced?

Jounce has introduced two additional LILRB family targets, LILRB1 and LILRB4, aimed at enhancing its immunotherapy development.

When is the expansion cohort initiation for JTX-8064 expected?

The initiation of expansion cohorts for JTX-8064 is expected in the third quarter of 2021.

What is the significance of the INNATE study for Jounce Therapeutics?

The INNATE study is significant as it aims to evaluate JTX-8064's efficacy, with potential implications for treating cancer patients with advanced solid tumors.