evixapodlin (GS-4224) / Gilead, OmRx Oncology - LARVOL DELTA

OmRx Oncology Initiates Phase 2 Trial of Oral PD-L1 Inhibitor OX-4224 in NSCLC (Businesswire) - "OmRx Oncology...today announced the initiation of a Phase 2 clinical trial of its investigational oral PD-L1 inhibitor, OX-4224, in patients with non-small cell lung cancer (NSCLC)....The trial will assess OX-4224 as a second line monotherapy, evaluating overall response rate in addition to safety and other secondary efficacy endpoints."

Trial status • Non Small Cell Lung Cancer

A PHASE 1B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NOVEL HEPATITIS B VIRUS COMBINATION THERAPIES IN PATIENTS LIVING WITH CHRONIC HEPATITIS B (AASLD 2024) - "Here we present results from a Phase 1b study that evaluated the following novel agents in combination regimens in patients with CHB: nivolumab (NIVO, anti–programmed death-1 monoclonal antibody); selgantolimod (SLGN; toll-like receptor 8 agonist); and/or GS-4224 (a novel small molecule programmed death ligand-1 inhibitor). Suppression of HBsAg was previously observed in HBV/HCV coinfected patients treated with ledipasvir/sofosbuvir (LDV/SOF)... Novel treatments and combinations for HBV cure in this trial were generally safe and well tolerated; however, only a few patients achieved a ≥0.5 log10 IU/mL decline from BL in HBsAg at FU W8 and no patient experienced HBsAg loss."

Clinical • Combination therapy • P1 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • TLR8

Oral PD-L1 inhibitor GS-4224 selectively engages PD-L1 high cells and elicits pharmacodynamic responses in patients with advanced solid tumors. (PubMed, J Immunother Cancer) - P1b/2 | "GS-4224 is a novel, orally bioavailable small molecule inhibitor of PD-L1. GS-4224 showed evidence of expected on-target biomarker activity, including engagement of PD-L1 and induction of immune-related pharmacodynamic responses consistent with PD-L1 blockade."

IO biomarker • Journal • Metastases • PK/PD data • Oncology • Solid Tumor

GS-4224: A potent, oral small molecule PD-L1 inhibitor (ACS-Fall 2022) - "GS-4224 was studied in a MC38 mouse tumor model where it demonstrated equivalent efficacy to a clinically approved antibody. In SAD and MAD phase I clinical studies GS-4224 was well tolerated and showed promising target engagement."

Oncology

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=18; Terminated; Sponsor: Gilead Sciences; N=120 ➔ 18; Trial completion date: May 2023 ➔ Mar 2021; Recruiting ➔ Terminated; Trial primary completion date: Apr 2023 ➔ Mar 2021; Gilead decision to terminate

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hodgkin Lymphoma • Melanoma • Neutropenia • Oncology • Solid Tumor • MSI • PD-1 • PD-L1

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=120; Recruiting; Sponsor: Gilead Sciences; Trial completion date: Aug 2022 ➔ May 2023; Trial primary completion date: Jul 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Neutropenia • Oncology • Solid Tumor • MSI • PD-1 • PD-L1

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=82; Recruiting; Sponsor: Gilead Sciences; Trial completion date: Dec 2021 ➔ Aug 2022; Trial primary completion date: Nov 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Neutropenia • Oncology • Solid Tumor • PD-1 • PD-L1

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=76; Recruiting; Sponsor: Gilead Sciences; Trial completion date: Aug 2021 ➔ Dec 2021; Trial primary completion date: Aug 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • PD-L1

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=76; Recruiting; Sponsor: Gilead Sciences; Trial completion date: Aug 2024 ➔ Aug 2021; Trial primary completion date: Aug 2024 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date

Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2; N=76; Recruiting; Sponsor: Gilead Sciences; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open