Jounce Therapeutics (JNCE) is a clinical-stage immunotherapy company developing therapies enabling the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce has ongoing multiple development stage programs while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science.
Jounce Therapeutics Lead Products
- JTX-8064 – a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. The product is in Phase 1 INNATE clinical trial being used as a monotherapy and in combination with pimivalimab, Jounce’s internal PD-1 inhibitor. The trial is currently enrolling patients with advanced solid tumors.
- Vopratelimab – a monoclonal antibody that binds to, and activates ICOS. It 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.
- JTX-1811 – a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment. Jounce obtained IND clearance for the product and exclusively licensed worldwide rights to Gilead Sciences, Inc. (GILD).
From the CEO & President of Jounce Therapeutics
Reporting on the 2nd 2021 financial results, Richard Murray, Ph.D., Chief Executive Officer and President of Jounce Therapeutics highlighted the progress Jounce has made in the quarter. He said, “We continued to advance our two proof of concept studies, INNATE and SELECT, achieved IND clearance on our fourth internally discovered program and expanded our discovery programs to include additional LILRB family members. Our team has made important and rapid progress in our INNATE study with the announcement today of monotherapy dose escalation enrollment completion and target dose selection. We look forward to beginning the next stages of the trial in third quarter of this year. We remain steadfast in our commitment to discover and develop novel IO therapies to meet the growing unmet medical need experienced in cancer patients, particularly in the area of PD-(L)1 inhibitor resistance. We believe our focus on translational science, biomarker approaches, and targeting new immune mechanisms leads us closer to bringing the right immunotherapies to the right patients.”
Jounce Therapeutics Pipeline Update
JTX-8064 (LILRB2 / ILT4)
- Completed enrollment in monotherapy dose escalation portion of INNATE Trial:
Jounce stated that the monotherapy dose escalation portion of the Phase 1 trial of JTX-8064 was completed. The monotherapy dose escalation included seven doses ranging from 50 mg to the highest planned dose of 1200 mg. To date, JTX-8064 has been well-tolerated with no dose limiting toxicities.
- Identified target dose for next stages of INNATE:
Jounce selected 700 mg target dose. The dose selection was based on a combination of safety, pharmacokinetic, and receptor occupancy data in the first three-week cycle. Jounce expects to open eight expansion cohorts for enrollment during the third quarter of 2021. One with JTX-8064 monotherapy at its target dose and seven with JTX-8064 in combination with pimivalimab.
- Presented trial in progress posters at ASCO 2021 Annual Meeting:
In June 2021, Jounce presented a trial in progress poster at the ASCO Annual Meeting on INNATE. The poster included the study design and the rationale for indications chosen for the expansion cohorts.
Vopratelimab (ICOS) and Pimivalimab (PD-1)
- Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TIS biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The SELECT trial also aims at providing additional important single agent data for pimivalimab in a new biomarker selection paradigm. Jounce is on track to report data from the SELECT trial in 2022.
Presenting trial in progress poster at the ASCO 2021 Annual Meeting:
In June 2021, Jounce presented a trial in progress poster at the ASCO Annual Meeting on SELECT. The poster described the study design, TIS biomarker, and patient selection strategy of the SELECT trial.
- Clearance of IND triggering first milestone under Gilead license agreement:
In June 2021, Jounce received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. The IND clearance triggered a $25.0 million milestone payment to Jounce which was received in July 2021. Gilead now has sole rights to develop and commercialize the JTX-1811 program, which will be referred to as GS-1811 in their pipeline.
Announcing new discovery program targets:
- Jounce continues to invest in and advance its growing immuno-oncology pipeline. The broad discovery pipeline includes multiple programs targeting diverse immune cell types and PD-(L)1 inhibitor resistance mechanisms.
- Jounce is rapidly advancing two additional LILRB family programs through discovery,
- One targeting LILRB1 and the other targeting LILRB4. The goal is submitting a new IND every 12 to 18 months, Jounce expects at least one of its next development candidates to target the LILRB family of receptors.
Second Quarter 2021 Financial Results:
Cash Position: As of June 30, 2021, cash, cash equivalents and investments were $246.1 M. compared to $213.2 million as of December 31, 2020.
License and Collaboration Revenue: Jounce recognized $25.4 M of license and collaboration revenue during the second quarter of 2021.
R&D Expenses: $22.1 million for the second quarter of 2021, compared to $21.0 million for the same period in 2020.
G&A Expenses: General and administrative expenses were $7.3 million for the second quarter of 2021, compared to $7.2 million for the same period in 2020. .
Net Loss: Net loss was $4.0 million for the second quarter of 2021, resulting in basic and diluted net loss per share of $0.08. Net loss was $28.0 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.82.
Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2021 to be approximately $95.0 million to $110.0 million.
Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.
We added Jounce Therapeutics to the Prohost Portfolio on October 23, 2020, and the stock walked in place. We believe that this firm might still yet be unknown to many investors, which is the reason that the stock did not perform.
Our enthusiasm towards this firm is based on its technologies and accomplishments.
The stock is trading now at $7.13, UP $0.66 following an upgrade by Raymond James from perform to outperform.
The stock is still affordable to those who are interested in this company that we believe has strong scientific and managerial fundamentals.
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