bapotulimab (BAY 1905254) / Compugen - LARVOL DELTA

KEYNOTE-920: Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Bayer | Active, not recruiting ➔ Completed | N=120 ➔ 60

Combination therapy • Enrollment change • Metastases • Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Oct 2023 ➔ Jun 2023

Combination therapy • Metastases • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Bayer | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ May 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Bayer | Trial completion date: May 2024 ➔ Oct 2025 | Trial primary completion date: Nov 2022 ➔ Oct 2023

Combination therapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254 (clinicaltrials.gov) - P1; N=196; Not yet recruiting; Sponsor: Bayer

Clinical • New P1 trial • Squamous Cell Carcinoma of Head and Neck • PD-L1

A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254 (clinicaltrials.gov) - P1; N=196; Recruiting; Sponsor: Bayer; Trial completion date: Nov 2021 ➔ Jul 2023; Trial primary completion date: Nov 2021 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254 (clinicaltrials.gov) - P1; N=196; Recruiting; Sponsor: Bayer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254 (clinicaltrials.gov) - P1; N=236; Recruiting; Sponsor: Bayer; Trial completion date: Jul 2023 ➔ Sep 2024; Trial primary completion date: Jul 2023 ➔ Sep 2024

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254 (clinicaltrials.gov) - P1; N=120; Recruiting; Sponsor: Bayer; N=236 ➔ 120; Trial completion date: Sep 2024 ➔ May 2024; Trial primary completion date: Sep 2024 ➔ Nov 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

Compugen reports second quarter 2018 results (PRNewswire) - "IND application for BAY 1905254, a first-in-class therapeutic antibody targeting ILDR2 being developed under license by Bayer AG, cleared by the FDA. First patient dosing in Phase 1 study for BAY 1905254 expected in 2018 and will trigger a milestone payment to Compugen."

Trial initiation date • Immune Modulation • Immunology

Characterization of BAY 1905254, an immune checkpoint inhibitor targeting the immunoglobulin-like domain containing receptor 2 (ILDR2). (PubMed, Cancer Immunol Res) - "Additive or even synergistic antitumor effects were observed when BAY 1905254 was administered in combination with anti-PD-L1, an immunogenic cell death-inducing chemotherapeutic, or with tumor antigen immunization. Taken together, our data showed that BAY 1905254 is a potential drug candidate for cancer immunotherapy, supporting its further evaluation."

Checkpoint inhibition • IO Biomarker • Journal • CNS Disorders • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Metabolic Disorders • Multiple Sclerosis • Oncology • Rheumatoid Arthritis • Rheumatology • TMB

Compugen announces publication of BAY 1905254 preclinical data in Cancer Immunology Research (PRNewswire) - “Compugen Ltd…announced today the publication of a peer reviewed paper titled ‘Characterization of BAY 1905254, a novel immune checkpoint inhibitor targeting the immunoglobulin-like domain containing receptor 2 (ILDR2)’ describing BAY 1905254's ability to trigger an anti-tumor immune response in mice, supporting its clinical evaluation as a cancer immunotherapy...ILDR2 is expressed by a specialized stromal cell subset so called fibroblastic reticular cells (FRCs) located in the lymph node where T cell priming and initiation of local T cell responses occur. Therefore, the hypothesis on the mode of action of BAY 1905254 is that the blockade of the immunosuppressive function of ILDR2 in the lymph node results in enhanced T cell priming, allowing for enhanced anti-cancer immune responses.”

Preclinical • Oncology