KK-LC-1 TCR therapy / T-Cure Biosci - LARVOL DELTA

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial primary completion date • Gene Therapies • Lung Cancer • Oncology • Solid Tumor

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Christian Hinrichs | Trial primary completion date: Sep 2025 ➔ Sep 2026

Gene therapy • Trial primary completion date • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Christian Hinrichs | Trial primary completion date: Sep 2023 ➔ Sep 2025

Gene therapy • Trial primary completion date • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2024 ➔ Apr 2026 | Trial primary completion date: Apr 2023 ➔ Apr 2025

Gene therapy • Trial completion date • Trial primary completion date • Gene Therapies • Lung Cancer • Oncology • Solid Tumor

A phase I trial of T-cell receptor gene therapy targeting KK-LC-1 for gastric, breast, cervical, lung and other KK-LC-1 positive epithelial cancers. (ASCO 2022) - P1 | "Patients receive a lymphocyte depleting conditioning regimen followed by a one-time infusion of genetically engineered T cells expressing the KK-LC-1 TCR (KK-LC-1 TCR-T cells) and high-dose systemic aldesleukin. The primary objective is to determine the maximally tolerated dose of KK-LC-1 TCR-T cells. Exploratory objectives include assessing the safety and efficacy of KK-LC-1 TCR-T cells and to conduct immunologic studies to understand and improve the administered treatment."

IO biomarker • P1 data • Breast Cancer • Cardiovascular • Cervical Cancer • Gene Therapies • Hematological Disorders • Immunology • Lung Cancer • Melanoma • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Synovial Sarcoma

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Christian Hinrichs | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Christian Hinrichs

New P1 trial • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Patient landscape of KK-LC-1+ epithelial tumors for adoptive T cell therapy (AACR 2022) - "NSG mice were dual flank injected with on and off-target tumors and dosed with KKLC1-TCR T cells... This data represents the first validated IHC for KKLC1 in these 6 tumor types. IHC reveals that though PAAD and BLCA show CT83 gene expression, they do not have detectable protein in tumor samples. GAST-AD, NSCLC, TNBC and CER-AD all have populations of patients with KKLC1+ tumors."

Clinical • IO biomarker • Bladder Cancer • Cervical Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • Urothelial Cancer

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting

Enrollment open • Gene Therapies • Lung Cancer • Oncology • Solid Tumor

T-Cure Bioscience, Inc. and Atlas Antibodies AB Enter a Collaboration Agreement for the Development, Manufacture, and Supply of CT83 (KK-LC-1) Monoclonal Antibodies (Businesswire) - "T-Cure Bioscience, Inc...and Atlas Antibodies AB...announced today a collaborative agreement for the development, manufacture, and supply of CT83 (KK-LC-1) mAb. These will be used to develop a diagnostic test to identify tumors that express KK-LC-1. Patients with KK-LC-1 positive tumors may be eligible for inclusion in clinical trials of a KK-LC-1 targeted T-Cell therapy. Under the terms of the agreement, Atlas Antibodies AB will provide all manufacturing and product supply for KK-LC-1 mAb for the companion diagnostic for clinical development...T-Cure plans to develop the companion diagnostic assay to identify KK-LC-1 positive cancer patients for inclusion in the company sponsored clinical trial planned for 2022."

Diagnostic • Licensing / partnership • New trial • Oncology • Solid Tumor

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

New P1 trial • Gene Therapies • Lung Cancer • Oncology • Solid Tumor

T-Cure Bioscience Announces U.S. FDA Clearance of Investigator-Initiated Clinical Trial for KK-LC-1 TCR-T Against Multiple Solid Tumors (Businesswire) - "...Dr. Gulley have extensive experiences in developing novel adoptive T-cell therapies for cancer and they will be invaluable as we advance this program."

T-Cure Bioscience Announces U.S. FDA Clearance of Investigator-Initiated Clinical Trial for KK-LC-1 TCR-T Against Multiple Solid Tumors (Businesswire) - "T-Cure Bioscience...announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I clinical study evaluating a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, breast cancers and other KK-LC-1 positive epithelial cancers..."

Trial status • Breast Cancer • Cervical Cancer • Gastric Cancer • Gynecologic Cancers • Lung Cancer • Oncology

[VIRTUAL] KK-LC-1 targeting T cell receptor for adoptive T cell therapy (AACR 2021) - "KK-LC-1 is a promising target for adoptive TCR cell therapy, and the 820TCR targeting KK-LC-1 is a highly potent and specific TCR with no observed off-target effects. A phase I clinical trial with 820TCR is being planned for patients with cervical, NSCLC, TNBC, and gastric cancers."

IO biomarker • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

T-Cure Bioscience Enters Into Agreement With Rutgers to Conduct Clinical Research of Novel T Cell Receptor Therapy for Treatment of Variety of Cancers (Businesswire) - “T-Cure Bioscience, Inc....announced that the Company has entered into a clinical research agreement with Rutgers, The State University of New Jersey, to fund a Phase I clinical study testing a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, and triple negative breast cancers….T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2021 at the NCI, with the clinical study responsibilities to be transferred to Rutgers in the second half of 2021.”

Licensing / partnership • Trial status • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer