denikitug (GS-1811) / Gilead - LARVOL DELTA

Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=376 | Recruiting | Sponsor: Gilead Sciences | N=216 ➔ 376 | Trial completion date: Feb 2027 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=216 | Recruiting | Sponsor: Gilead Sciences | N=158 ➔ 216 | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2024 ➔ Jun 2026

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results (Businesswire) - "Acquired in-process research and development ('IPR&D') expenses for the fourth quarter 2022 were $158 million compared to $669 million in the same period in 2021. Fourth quarter 2022 expenses primarily relate to the acquisition of GS-1811 from Jounce and the MacroGenics upfront payment. Fourth quarter 2021 expenses mostly relate to the charge for the Arcus collaboration opt-in."

Commercial • Oncology • Solid Tumor

Gilead to Acquire All Remaining Rights to Potential First-in-Class Immunotherapy GS-1811 From Jounce Therapeutics (Businesswire) - "Gilead Sciences...and Jounce Therapeutics...amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buy out remaining contingent payments potentially due under the license agreement executed in August 2020. As part of the transaction, certain operational obligations of the parties related to GS-1811, an anti-CCR8 antibody, set forth in the license agreement have also been terminated. Gilead will acquire certain related intellectual property, including all outstanding rights of Jounce to GS-1811, pursuant to the transaction agreement....Jounce will receive proceeds of $67 million for this transaction, and Gilead will be solely responsible for all further research, development and commercialization of GS-1811 globally."

Licensing / partnership • Oncology • Solid Tumor

"$JNCE Gilead To Acquire All Remaining Rights To Potential First-In-Class Immunotherapy GS-1811 From Jounce Therapeutics https://t.co/OF2bjjPvIl" (@stock_titan)

Differential expression of CCR8 in tumors versus normal tissue allows specific depletion of tumor-infiltrating T regulatory cells by GS-1811, a novel Fc-optimized anti-CCR8 antibody. (PubMed, Oncoimmunology) - "Targeting CCR8 in mouse tumor models results in robust anti-tumor efficacy, which is dependent on Treg depleting activity, and synergizes with PD-1 inhibition to promote anti-tumor responses in PD-1 resistant models. Our data support clinical development of GS-1811 to target CCR8 in cancer and drive tumor Treg depletion in order to promote anti-tumor immunity."

IO biomarker • Journal • Oncology • CCR8

Jounce Therapeutics earns clinical milestone payment under the CCR8 exclusive license agreement with Gilead Sciences, Inc. (GlobeNewswire) - "Jounce Therapeutics...announced today earning a $15.0 million clinical milestone payment from Gilead Sciences...under the exclusive license agreement for GS-1811, an anti-CCR8 antibody for which Gilead has exclusive rights to develop and commercialize. GS-1811 (formerly JTX-1811) is designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells in the tumor microenvironment. Under the terms of the September 2020 agreement, Gilead invested $35.0 million in Jounce’s common stock and made an $85.0 million upfront payment to Jounce. Jounce led the development of JTX-1811 through IND clearance, after which Gilead obtained the sole right to develop and commercialize the program."

Financing • Licensing / partnership • Oncology • Solid Tumor

Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=158 | Recruiting | Sponsor: Gilead Sciences | N=62 ➔ 158

Combination therapy • Enrollment change • Monotherapy • Oncology • Solid Tumor

Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Pembrolizumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Gilead Sciences; Trial primary completion date: May 2024 ➔ Feb 2024

Clinical • Combination therapy • Monotherapy • Trial primary completion date • Oncology • Solid Tumor

Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Pembrolizumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Gilead Sciences; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor

Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Pembrolizumab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=62; Not yet recruiting; Sponsor: Gilead Sciences

Clinical • Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

Jounce Therapeutics Achieves First Milestone in Exclusive License Agreement with Gilead Sciences and FDA Clearance of Investigational New Drug Application for Anti-CCR8 Antibody (GlobeNewswire) - "Jounce Therapeutics, Inc...announced the U.S. Food and Drug Administration’s (FDA) clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc...has exclusive rights to develop and commercialize. The IND clearance triggers a $25.0 million milestone payment to Jounce."

Commercial • IND • Oncology

Jounce Therapeutics Reports First Quarter 2021 Financial Results (GlobeNewswire) - "JTX-1811 remains on track for an investigational new drug application ('IND') clearance in 2021 at which point Gilead Sciences, Inc. will take over clinical development and potential commercialization."

IND • Oncology

Jounce Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results (GlobeNewswire) - “…Jounce initiated enrollment in the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014 versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line non-small cell lung cancer patients…Jounce now anticipates reporting data from the SELECT trial in 2022; Jounce continues to progress JTX-1811 to IND clearance and remains on track for an IND filing in the first half of 2021.”

Enrollment status • IND • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Jounce Therapeutics Reports Third Quarter 2020 Financial Results (GlobeNewswire) - “Initiated Phase 2 SELECT trial of vopratelimab: Jounce initiated the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014…Jounce expects to enroll approximately 75 patients outside the U.S. and expects to report clinical data in late 2021…On track to initiate Phase 1 clinical trial of JTX-8064 by year-end 2020. Established exclusive license agreement with Gilead for the development and commercialization of JTX-1811: Under the terms of the agreement, Jounce continues to progress JTX-1811 to IND clearance and is on track for an IND filing in the first half 2021.”

Enrollment status • IND • Licensing / partnership • New P1 trial • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for Novel Immunotherapy Program (GlobeNewswire) - "Gilead Sciences, Inc…announced an agreement with Jounce Therapeutics, Inc….to exclusively license its JTX-1811 program. JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells…The antibody remains on track for filing an Investigational New Drug (IND) application in the first half of 2021…Under the terms of the agreement, Gilead will make a $85 million upfront payment to, and a $35 million equity investment at a premium in, Jounce upon closing. In addition, Jounce may receive up to an additional $685 million in future clinical, regulatory and commercial milestone payments. Jounce will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales, subject to certain adjustments…This transaction, which is expected to close in the second half of 2020…"

IND • Licensing / partnership • Oncology

Gilead Licenses Novel Immunotherapy From Jounce (Scripintelligence) - "Deal snapshot: Gilead’s latest significant cancer deal brings it a CCR8 binder, a novel preclinical immunotherapy, while Jounce finds a new deep-pocketed partner after the termination of its collaboration with Celgene."

Licensing / partnership • Oncology

".@GileadSciences to pay @JounceTx $85M up front to license experimental #cancer drug JTX-1811 https://t.co/Fr7CRnIGnI $JNCE $GILD" (@SPGMIHealthcare)

Oncology

[VIRTUAL] Profiling the Tumor Microenvironment for Immunotherapy Targets (IOS 2020) - "Jounce’s translational platform utilizes thousands of human tumor samples and advanced bioinformatics to probe the tumor microenvironment for immuno-oncology targets that could be relevant in T cell checkpoint-resistant tumors and/or expand the number of patients benefiting from checkpoint therapy. The latest therapeutic candidate to emerge from our platform is JTX-1811, a monoclonal antibody intended to specifically deplete intra-tumoral T regulatory cells with activity demonstrated preclinically in anti-PD-1 resistant tumors."

Biomarker • Tumor microenvironment • Oncology

Jounce Therapeutics Reports Second Quarter 2020 Financial Results (GlobeNewswire) - "[for JTX-4014] Jounce is on track to complete this analysis of preliminary efficacy and biomarker data on more than 40 evaluable patients at different doses in early 2021… Jounce expects to enroll approximately 75 patients outside the U.S. and expects to report clinical data in 2021…JTX-8064 inhibits this immunosuppressive interaction, reprogramming the macrophages to a more immuno-stimulatory state. Jounce expects to begin enrollment in the Phase 1 dose escalation trial of JTX-8064 in 2020….Jounce plans to continue IND-enabling activities for JTX-1811 and remains on track to file an Investigational New Drug, or IND, in the first half of 2021."

Enrollment status • IND • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

[VIRTUAL] Preclinical evaluation of JTX-1811, an anti-CCR8 antibody with enhanced ADCC activity, for preferential depletion of tumor-infiltrating regulatory T cells (AACR-II 2020) - "Based on these pre-clinical data JTX-1811, a high affinity CCR8-specific humanized monoclonal antibody with enhanced ADCC activity, is being developed for the selective depletion of tumor-infiltrating Tregs. JTX-1811 may be useful in PD-1 resistant settings and may restore the activity of PD-1 inhibitors in the setting of primary or acquired resistance to ICB."

IO Biomarker • Preclinical • Oncology

Jounce Therapeutics Presents First Preclinical Data on Anti-CCR8 Antibody JTX-1811 and Vopratelimab Translational Data at The American Association for Cancer Research Virtual Annual Meeting (GlobeNewswire) - "Key highlights from the poster titled, 'Preclinical evaluation of JTX-1811, an anti-CCR8 antibody with enhanced ADCC activity, for preferential depletion of tumor-infiltrating regulatory T cells' include:...Tumor-infiltrating T-regulatory (TITR) cells suppress anti-tumor immunity in the tumor microenvironment; CCR8 may be a superior target for TITR cells because it is expressed at high densities on the cell surface of tumor T-regulatory cells."

Preclinical • Oncology

Jounce Therapeutics to present first preclinical data on anti-CCR8 antibody JTX-1811 and vopratelimab translational data at the American Association for Cancer Research Virtual Annual Meeting (GlobeNewswire) - "Jounce Therapeutics, Inc…announced two upcoming virtual poster presentations introducing the first preclinical data from the JTX-1811 program and data on the characterization of treatment emergent ICOS hi CD4 T cells with vopratelimab and their association with durable clinical responses. These posters will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting, being held June 22-24, 2020."

Preclinical • Oncology

Jounce Therapeutics reports first quarter 2020 financial results (GlobeNewswire) - "Pre-Clinical Program: JTX-1811, Announced CCR8 as the JTX-1811 target: Jounce will present new preclinical data at the second portion of the virtual 2020 American Association for Cancer Research (AACR) annual meeting being held June 22-24 and expects to file an Investigational New Drug (IND) application in the first half of 2021."

IND • Preclinical • Oncology