pimivalimab (JTX-4014) / Concentra Biosci - LARVOL DELTA

Leukocyte immunoglobulin-like receptor (LILRB2)-targeted JTX-8064 plus the anti-PD1 inhibitor JTX-4014 (pimivalimab) in immune-checkpoint inhibitor (ICl)­ pretreated patients (pts) with advanced or metastatic renal cell cancer (mRCC): Results from the multi-stage phase 1-2 INNATE trial. (ASCO 2024) - P1/2 | "While ORR did not meet the protocol-defined efficacy target, evidence of anti tumor activity was seen in ICI pre-treated mRCC pts with combination JTC-8064 + JTX-4014. Treatment was reasonably well-tolerated. Identification & evaluation of clinical and molecular phenotypes most likely to benefit from LILRB2-targeted therapies are warranted."

Checkpoint inhibition • Clinical • Metastases • P1/2 data • Cardiovascular • Fatigue • Genito-urinary Cancer • Hematological Disorders • Hypotension • Oncology • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov) - P2 | N=69 | Terminated | Sponsor: Jounce Therapeutics, Inc. | Active, not recruiting ➔ Terminated; The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.

Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov) - P2 | N=69 | Active, not recruiting | Sponsor: Jounce Therapeutics, Inc. | Trial primary completion date: Sep 2022 ➔ May 2024

Biomarker • Combination therapy • IO biomarker • Metastases • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=190 | Completed | Sponsor: Jounce Therapeutics, Inc. | Active, not recruiting ➔ Completed | N=281 ➔ 190

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Biliary Tract Cancer • Breast Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • ALK • EGFR • FGFR • IDH1 • PD-L1

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov) - P2 | N=69 | Active, not recruiting | Sponsor: Jounce Therapeutics, Inc. | Trial completion date: Mar 2023 ➔ May 2024

Biomarker • Combination therapy • IO biomarker • Metastases • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Jounce Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Feb 2023

Trial completion • Trial completion date • Oncology • Solid Tumor

Concentra Biosciences to Acquire Jounce Therapeutics (Precision Oncology News) - "Jounce Therapeutics...said it will be acquired by Concentra Biosciences and lay off 84 percent of its workforce. Concentra will acquire Jounce for $1.85 in cash per share plus a non-tradeable contingent value right (CVR). The CVR will provide Jounce shareholders the right to receive 80 percent of the net proceeds from any license or disposition of Jounce's programs effected within two years of closing and 100 percent of the potential aggregate value of certain specified potential cost savings. The acquisition is projected to close in the second quarter of 2023....According to the company, the remaining Jounce employees will work to ensure that patients on the SELECT and INNATE trials have the opportunity to continue receiving therapy with vopratelimab, JTX-8064, and pimivalimab, along with completing the acquisition and conducting activities to maximize the value of the CVR."

M&A • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thoracic Cancer • Triple Negative Breast Cancer • Undifferentiated Pleomorphic Sarcoma • Urothelial Cancer • Uterine Cancer

INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=281 | Active, not recruiting | Sponsor: Jounce Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Biliary Tract Cancer • Breast Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • ALK • EGFR • FGFR • IDH1 • PD-L1

Jounce Therapeutics Announces Results from Pre-Planned Data Review of INNATE Phase 2 Trial of JTX-8064 and Pimivalimab Demonstrating Deep and Durable Responses in Platinum Resistant Ovarian Cancer (GlobeNewswire) - P1/2 | N=281 | INNATE (NCT04669899) | Sponsor: Jounce Therapeutics, Inc. | "In this cohort, 35 patients with third- and fourth-line platinum resistant ovarian cancer were treated with JTX-8064 and Jounce’s PD-1 inhibitor, pimivalimab. There were five RECIST 1.1 responders, four of which are confirmed, with all five patients remaining on study for over six months with continued tumor reduction over time. The remaining 30 patients have discontinued treatment....In patients with one to six prior lines of therapy for ovarian cancer, pembrolizumab monotherapy demonstrated a response rate of 8.5%, with duration of response of 10.2 months."

P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer

Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. (ASCO-SITC 2020) - P1/2; "Background: ICOS is a costimulatory molecule upregulated on activated T cells. In this retrospective subset analysis, the RS score, but not PD-L1, in baseline tumor biopsies was predictive of emergence of an ICOS hi CD4 T cell population and improved RECIST response, PFS, and OS in patients treated with vopra alone and in combination with nivo. Clinical evaluation of vopra and investigational PD-1 inhibitor JTX-4014 in cancer patients with RS selection is planned. Research Funding: Jounce Therapeutics."

Clinical • IO Biomarker • Oncology • Solid Tumor • GS • PD-L1

SELECT: A phase 2 randomized trial evaluating 2 doses of vopratelimab (V) + pimivalimab (P) vs P in TISvopra selected patients (pts) (ESMO-IO 2022) - P2 | "Tumor inflammation signature (TIS) at and above a designated cut-off, termed TISvopra, was previously associated with improved clinical outcomes in patients treated with V +/- nivolumab. P is active and continues to be used in combination trials. Shorter TE duration of V 0.03 mg/kg may contribute to clinical activity."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ICOS • PD-L1

Phase 1 Study of JTX-8064, a LILRB2 (ILT4) inhibitor, as monotherapy and combination with pimivalimab (pimi), a PD-1 inhibitor (PD-1i), in patients (pts) with advanced solid tumors (ESMO-IO 2022) - P1/2 | "Conclusions JTX-8064 was well-tolerated as mono and with pimi, with 700 mg q3w selected as the preliminary RP2D. Enrollment is ongoing in P2, including cohorts in renal and ovarian cancer that have met Simon's 2-stage response criteria to expand."

Clinical • Monotherapy • P1 data • Appendix Cancer • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Jounce Therapeutics Presents INNATE Phase 1 and SELECT Clinical Trial data at the European Society of Medical Oncology Immuno-Oncology (ESMO - IO) Annual Congress (PRNewswire) - P2 | N=75 | SELECT (NCT04549025) | Sponsor: Jounce Therapeutics, Inc. | "'SELECT: A phase II randomized trial evaluating 2 doses of vopratelimab (V) + pimivalimab (P) vs P in TISvopra selected patients (pts)' of the vopra plus pimi SELECT trial included an update to data previously announced on clinical endpoints, including additional durability data for patients who remain on study....primary endpoint (percent change from baseline of all measurable lesions averaged over 9 and 18 weeks), ORR, and progression free survival (PFS). ORR was 40% (95% confidence intervals [CI]16.34, 67.71) for low dose vopra combination cohort, 27.8% (CI 14.20, 45.19) for pimi alone, and 16.7% (CI 3.58, 41.42) for high dose vopra combination cohort. Six month landmark PFS was 80% (CI 50, 93) for low dose vopra combination, 36% (CI 20, 53) for pimi monotherapy, and 31% (CI 11, 52) for high dose vopra combination."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Jounce Therapeutics Reports Third Quarter 2022 Financial Results (GlobeNewswire) - P2 | N=75 | SELECT (NCT04549025) | Sponsor: Jounce Therapeutics, Inc. | "Vopratelimab (ICOS) and Pimivalimab (PD-1): SELECT Phase 2 data to be presented at ESMO-IO Annual Congress 2022...SELECT is a randomized Phase 2 trial evaluating vopratelimab (vopra), Jounce’s inducible T cell costimulator (ICOS) agonist, in combination with pimi versus pimi alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer patients....As previously reported, vopra 0.03 mg/kg in combination with pimi resulted in a 40% response rate and an 80% six month landmark progression-free survival (PFS) by independent central radiology review. These continue to compare favorably to updated results for pimi monotherapy, with a 27.8% response rate and 36% six month landmark PFS, as will be reported at ESMO-IO. Jounce plans to pursue a partnership to enable further development of vopra 0.03 mg/kg in combination with a PD-1 inhibitor."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Jounce Therapeutics to Present Multiple Posters at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting and the European Society of Medical Oncology Immuno-Oncology (ESMO-IO) Annual Congress (GlobeNewswire) - "Two clinical poster presentations will be made at the ESMO-IO 2022 Annual Congress being held in Geneva, December 7-9. The submitted abstract for the JTX-8064 INNATE trial contains Phase 1 data, including safety, PK, and tumor response data. Jounce continues to expect to report preliminary clinical data on at least 80 Phase 2 patients from the INNATE trial by end of year 2022. The submitted abstract for the vopratelimab/pimivalimab SELECT trial includes all data previously announced on clinical endpoints. Additional durability data for patients who remain on study will also be reported."

P1 data • P2 data • Oncology • Solid Tumor

Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Jounce Therapeutics, Inc. | N=40 ➔ 18 | Trial completion date: Aug 2022 ➔ Aug 2023

Enrollment change • Trial completion date • Oncology • Solid Tumor

Jounce Therapeutics Reports Results from Phase 2 Randomized SELECT Trial Testing 2 Different Doses of Vopratelimab in TISvopra Biomarker-Selected Patients (GlobeNewswire) - P2 | N=75 | SELECT (NCT04549025) | Sponsor: Jounce Therapeutics, Inc. | "As the study was powered to detect a 20% absolute difference of the pooled combo doses compared to pimi monotherapy, and the actual difference was 7%, SELECT did not meet its primary endpoint. In the combination dose cohort with the lowest dose of vopra (0.03mg/kg), interesting trends were observed in both the primary endpoint, with an absolute mean change of 15%, and in the prespecified secondary endpoints of overall response rate (ORR), which was 40% compared to 25% in pimi alone, and landmark six month progression free survival (PFS) of 80% compared to 33% with pimi alone....We plan to submit a clinical abstract to present the entire SELECT study, including more mature data, at the ESMO Immuno-Oncology Congress in December 2022."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Jounce Therapeutics Reports Second Quarter 2022 Financial Results (GlobeNewswire) - "Vopratelimab (ICOS) and Pimivalimab (PD-1): On track to report clinical data before year end. Jounce plans to submit a clinical data abstract on the SELECT trial, including additional single agent data for pimivalimab, to the ESMO Immuno-Oncology Congress 2022....JTX-1484 (LILRB4/ILT3): Jounce has submitted a preclinical abstract on JTX-1484 for consideration at this year’s annual Society for Immunotherapy of Cancer (SITC) meeting being held from November 9-11 in Boston, MA."

P2 data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Jounce Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2021 ➔ Sep 2022

Biomarker • Combination therapy • Enrollment closed • IO biomarker • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1/2; N=281; Recruiting; Sponsor: Jounce Therapeutics, Inc.; Phase classification: P1 ➔ P1/2

Clinical • Combination therapy • Monotherapy • Phase classification • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • EGFR • PD-L1

Jounce Therapeutics Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "Continued enrollment in Phase 2 SELECT trial of vopratelimab: Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The SELECT trial also aims to provide 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."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Jounce Therapeutics Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "JTX-8064 (LILRB2 / ILT4): Jounce has completed the monotherapy and pimivalimab (PD-1 Inhibitor) combination therapy dose escalation 3 week safety review of the Phase 1 trial of JTX-8064, and a preliminary recommended phase 2 dose (RP2D) of 700 mg has been established....The clinical study of GS-1811 (formerly JTX-1811) was initiated by Gilead Sciences. GS-1811, which Jounce discovered and progressed through to IND, is out licensed to Gilead and is the fourth internally developed candidate to enter the clinic....Research and development expenses were $23.3 million for the third quarter of 2021, compared to $18.0 million for the same period in 2020. The increase in research and development expenses was primarily due to increased clinical and regulatory costs for INNATE and SELECT..."

Commercial • Trial status • Oncology

Jounce Therapeutics Progresses INNATE Study of JTX-8064 (LILRB2/ILT4 Inhibitor) Monotherapy and Pimivalimab (PD-1 Inhibitor) Combination Therapy in Patients with Advanced Solid Tumors (GlobeNewswire) - "Jounce Therapeutics, Inc...announced the initiation of patient enrollment in INNATE tumor-specific expansion cohorts for both JTX-8064 monotherapy and combination therapy of JTX-8064 with its internal PD-1 inhibitor, pimivalimab....POC expansion cohorts in INNATE follow a Simon’s two-stage design with the potential to enroll up to 29 patients per combination cohort and 47 patients in the monotherapy cohort if pre-specified criteria are met. If POC is established after evaluation of 29 or 47 patients, respectively, Jounce intends to move JTX-8064 rapidly into registrational trials on a cohort by cohort basis."

Trial status • Breast Cancer • Gynecologic Cancers • Head and Neck Cancer • Liposarcoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Phase 1 First in Human Study of Programmed Cell Death Receptor-1(PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects with Advanced Refractory Solid Tumor Malignancies (SITC 2019) - "JTX-4014 is well-tolerated and appears to have similar qualities to known anti-PD-1 inhibitors in terms of pre-clinical and clinical characteristics. Antitumor activity was observed in the difficult to treat population enrolled. Phase 2 testing JTX-4014 is planned."

Clinical • IO Biomarker • P1 data • PD(L)-1 Biomarker

[VIRTUAL] 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). (ASCO 2021) - P1 | " The primary objectives of this open-label, phase 1, first-in-human, multicenter trial are to determine the safety and tolerability, and the recommended phase 2 dose (RP2D) of JTX-8064 as a monotherapy and in combination with a PD-1i, JTX-4014 (a Jounce investigational agent) or pembrolizumab, in patients with advanced solid tumors (NCT04669899) . INNATE will assess pharmacodynamic and potential predictive biomarkers of response, and the expansion cohorts will explore multiple patient populations, including PD-(L)1i sensitive and PD-(L)1i-resistant (primary or acquired) patients to address current unmet medical needs . Enrolment in INNATE began in January 2021."

Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Immune Modulation • Inflammation • Oncology • Solid Tumor • IFNG