denikitug (GS-1811) / Gilead - LARVOL DELTA

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=304 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Monotherapy • Oncology • Solid Tumor

Preliminary results of a phase 1, first-in-human, dose-escalation study of the anti-CCR8 antibody denikitug in participants with advanced solid tumors (AACR 2026) - P1 | "DEN is pharmacologically active at doses ≥ 10 mg as shown by CCR8+ itTreg depletion with concurrent increase in Teff infiltration in tumor tissue. Gene expression changes of key biomarkers indicate biologic activity within the tumor microenvironment. DEN demonstrates a manageable safety profile and TRAEs were consistent with a Treg depleting mechanism of action."

First-in-human • IO biomarker • Metastases • P1 data • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • Vaginal Cancer • CCR8 • CD8 • IFNG

GS-US-742-7757: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (clinicaltrialsregister.eu) - P1/2 | N=45 | Not yet recruiting | Sponsor: Gilead Sciences Inc.

Monotherapy • New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Colorectal Cancer • Oncology • Solid Tumor

GS-US-741-7756: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults with Advanced Colorectal Cancer. (clinicaltrialsregister.eu) - P1/2 | N=75 | Not yet recruiting | Sponsor: Gilead Sciences Inc.

Monotherapy • New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS

GS-US-741-7756: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults with Advanced Colorectal Cancer. (clinicaltrialsregister.eu) - P1/2 | N=94 | Not yet recruiting | Sponsor: Gilead Sciences Inc.

Monotherapy • New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS

GS-US-742-7757: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (clinicaltrialsregister.eu) - P1/2 | N=26 | Not yet recruiting | Sponsor: Gilead Sciences Inc.

Monotherapy • New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Gilead Sciences

Monotherapy • New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Gilead Sciences

Monotherapy • New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=416 | Recruiting | Sponsor: Gilead Sciences | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Dec 2027 ➔ Dec 2028

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=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