polzastobart (JTX-8064) / 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

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

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

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 Announces Restructuring (Market Screener) - "Jounce Therapeutics, Inc...announced today that it is reducing its workforce by approximately 57 percent. The decision to reduce its workforce was made as Jounce believes advancement of its clinical programs, JTX-8064 and vopratelimab, requires funding and a scope that the Company cannot pursue on its own and will be seeking business development opportunities for both programs....Jounce expects to incur a non-recurring charge of approximately $11.2i million in the first quarter of 2023 related to the restructuring announced today. The workforce reduction will be substantially completed by March 31, 2023."

Commercial • Licensing / partnership • Oncology • Solid Tumor

Inhibition of LILRB2 by a Novel Blocking Antibody Designed to Reprogram Immunosuppressive Macrophages to Drive T Cell Activation in Tumors. (PubMed, Mol Cancer Ther) - "In a human tumor explant culture, pharmacodynamic activity of JTX-8064 was observed in monotherapy and in combination with anti-PD-1. Collectively, our work provides strong translational and pre-clinical rationale to target LILRB2 in cancer."

IO biomarker • Journal • Oncology • Solid Tumor • CD163 • ITGAM

Jounce Therapeutics Presents INNATE Phase 1 and SELECT Clinical Trial data at the European Society of Medical Oncology Immuno-Oncology (ESMO - IO) Annual Congress (GlobeNewswire) - P1 | N=281 | INNATE (NCT04669899) | Sponsor: Jounce Therapeutics, Inc. | "Jounce Therapeutics...reported new clinical data from the INNATE trial with JTX-8064 and pimi and the SELECT trial with vopra and pimi in two poster presentations at the ESMO-IO 2022 Annual Congress being held in Geneva, Switzerland....Thirty-one patients were treated in dose escalation, 22 JTX-8064 mono, and nine JTX-8064 plus pimi....Phase 1 efficacy data in the mono cohort (n=22): zero partial response (PR), seven (35%) stable disease (SD) including two durable SD (appendiceal cancer 8.3, ovarian cancer 12.2 months). Phase 1 efficacy data in the combo cohort (n=9): one confirmed PR (6.2 months) at 700 mg in a PD-1i resistant cholangiocarcinoma patient (PD-L1 score of 0) and resolution of both bone pain and cachexia, three (33%) SD with one durable SD of 6 months (PD-1i resistant NSCLC). Enrollment into multiple expansion cohorts is ongoing."

P1 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Jounce Therapeutics Presents INNATE Phase 1 and SELECT Clinical Trial data at the European Society of Medical Oncology Immuno-Oncology (ESMO - IO) Annual Congress (GlobeNewswire) - "Preclinical data demonstrating that a shorter period of target engagement with vopra in vitro stimulates T cells without the exhaustion seen with longer treatment was also summarized in the poster. This data provides a scientific rationale that clinical outcomes obtained with lower doses of vopra may be improved relative to doses that result in continuous target engagement, as the SELECT clinical data suggests. Jounce plans to pursue a partnership to enable further development of vopra 0.03 mg/kg in combination with a PD-1 inhibitor."

Preclinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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

Jounce Therapeutics Reports First Quarter 2022 Financial Results (GlobeNewswire) - "Pipeline Update & Highlights: JTX-8064 (LILRB2/ILT4)- On track to report preliminary clinical data in the second half of 2022. The INNATE clinical trial is studying three distinct patient populations across the 7 indications...Jounce remains on track to report preliminary clinical data, including all 31 dose escalation patients and at least 60 Phase 2 patients from INNATE, in the second half of 2022."

P2 data • Oncology

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) - "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

[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

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; N=281; Recruiting; Sponsor: Jounce Therapeutics, Inc.; N=40 ➔ 281; Trial completion date: Sep 2022 ➔ Jan 2024; Trial primary completion date: Jul 2022 ➔ Sep 2023

Clinical • Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • 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 Provides Update on INNATE Study and Discovery Pipeline Expansion, and Provides a Portfolio Update at 2021 R&D Day (GlobeNewswire) - “Presentations will highlight Jounce’s productive discovery engine and platform, updates on its discovery pipeline, and progress on the clinical development of JTX-8064…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.”

Clinical data • IND • Trial status • Oncology • Solid Tumor

Jounce Therapeutics Presents Trial in Progress Posters on the INNATE and SELECT Clinical Trials at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting (GlobeNewswire) - "Jounce Therapeutics... today presented two trial in progress posters, on the Phase 1 INNATE clinical trial and the Phase 2 SELECT clinical trial, at the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. INNATE, a proof-of-concept (POC) trial, is evaluating Jounce’s lead macrophage program JTX-8064 (anti-LILRB2/ILT4 inhibitor) as a monotherapy and in combination with pimivalimab (anti-PD-1 inhibitor, formerly known as JTX-4014) in patients with a variety of advanced solid tumors...SELECT is on-track to report clinical data in 2022."

P1 data • P2 data • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] Tumor associated macrophages and resistance to immune checkpoint blockade: consideration of cancer indications for the clinical development of JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody (AACR 2021) - "The activities of JTX-8064 in cell culture and high LILRB2 expression in non-responding patients with high levels of IFNg signature expression provides a rationale that JTX-8064 may be able to overcome anti-PD-1 primary resistance mechanisms. JTX-8064 is currently in Phase 1 clinical development as a monotherapy and combination with anti-PD-1 inhibitors in settings with both anti-PD-1(L1) naïve and anti-PD-1(L1) experienced patients in specific cancer types."

Checkpoint inhibition • Clinical • IO biomarker • Oncology • IFNG

Jounce Therapeutics Reports First Quarter 2021 Financial Results (GlobeNewswire) - "JTX-8064: INNATE remains on track for the opening of eight expansion cohorts in the second half of the year, one with JTX-8064 monotherapy, and seven in combination with a PD-1 inhibitor...On June 4, 2021 Jounce will present a trial in progress poster at the ASCO Annual Meeting on INNATE. The poster will include the study design and the rationale for indications chosen for the expansion cohorts."

Clinical protocol • Trial status • Oncology

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 (GlobeNewswire) - “Jounce Therapeutics, Inc…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); 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).”

P1 data • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Jounce Therapeutics Presents Preclinical Data from JTX-8064/LILRB2 Program at the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting (GlobeNewswire) - “Jounce Therapeutics, Inc…reported new preclinical data on JTX-8064…Jounce demonstrated: JTX-8064 can induce T cell activation in co-culture with macrophages, demonstrating its potential to bridge the gap between innate and adaptive immune responses; CD163+ M2 macrophages co-localize with T cells in the tumor microenvironment, and patients with high levels of LILRB2 or a proprietary tumor-associated macrophage (TAM) signature score relative to an IFNγ signature score are less responsive to PD-(L)1 inhibitors, providing evidence that LILRB2+ macrophages may be involved in mechanisms of primary resistance to PD-(L)1 inhibitors…”

Preclinical • Oncology

Jounce Therapeutics to Present Preclinical Data from JTX-8064 Program at the 2021 American Association for Cancer Research Virtual (AACR) Annual Meeting (GlobeNewswire) - "Jounce Therapeutics...announced that preclinical data informing indication selection for the clinical development of its lead macrophage program, JTX-8064, will be presented in a poster session at the upcoming 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting being held April 10- 15, 2021."

Preclinical • Oncology

Jounce Therapeutics Announces Pricing of $56.25 Million Public Offering of Common Stock (GlobeNewswire) - “Jounce Therapeutics…announced that it has priced an underwritten public offering of 5,000,000 shares of common stock at a public offering price of $11.25 per share, which would result in gross proceeds of approximately $56.25 million, before underwriting discounts and commissions. The proceeds of the offering are expected to be used to fund ongoing and planned clinical trials, including the INNATE trial of JTX-8064, to fund research and development to advance Jounce’s pipeline, and for working capital and other general corporate purposes.”

Financing • Oncology