EU204 / Eutilex - LARVOL DELTA

Phase 1 trial of 4-1BB-based adoptive T-cell therapy targeting human telomerase reverse transcriptase in patients with advanced refractory solid tumors. (PubMed, Cytotherapy) - "The generation of TERTiNTs was feasible and safe and provided an interesting disease control rate in heavily pre-treated cancer patients."

Journal • Metastases • P1 data • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CD8 • TERT

Eutilex begins phase 2 clinical trial for ENKL patients with 204 treatment [Google translation] (Eutilex Press Release) - "Eutilex Co., Ltd...killer T cell therapy drug '204 (EBViNT, ABBNT)' starts phase 2 clinical trial...204 treatment is in phase 1/2a clinical trials for EBV-positive lymphoma and solid cancer patients. After the completion of the recent phase 1 clinical trial, the process of reading the results remains, and its safety was acknowledged first, and phase 2 clinical trial patient recruitment was approved....Accordingly, Eutilex starts recruiting the phase 2a clinical trial group for ENKL patients."

Trial status • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Eutilex applies for orphan drug status for killer T-cell anticancer therapy (Korea Biomedical Review) - "Eutilex said it has submitted an orphan drug designation (ODD) application for EU204, a killer T-cell treatment targeting Epstein-Barr virus (EBV)-positive cancer patients, to the U.S. Food and Drug Administration. EU204 is undergoing phase 1 and 2a clinical trials in Korea for patients with EBV-positive lymphoma and solid cancer."

Orphan drug • Oncology • Solid Tumor

Clinical Trial to Evaluate the Efficacy and Safety of Epstein-Barr Virus Induced Natural T Lymphocyte(EBViNT) Cell in Patients With Progressive EBV Positive Extranodal NK/T-cell Lymphoma Where Standard Treatments Have Failed (clinicaltrials.gov) - P1/2; N=72; Recruiting; Sponsor: Eutilex; N=28 ➔ 72

Clinical • Enrollment change • Epstein-Barr Virus Infections • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Eutilex resumes trial of immunotherapy EBViNT (Korea Biomedical Review) - "Eutilex said it has resumed the clinical trial of immunotherapy EBViNT, 30 months after the regulator suspended the trial. The resumption took longer than the market expected, but it draws attention to whether Eutilex will compensate for the delayed development....On Tuesday, the company said that it administered the EBViNT, a treatment for natural killer T (NK/T) cell lymphoma and gastric cancer, to the first patient in the phase 1/2a trial."

Trial status • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology

Clinical Trial to Evaluate the Efficacy and Safety of Epstein-Barr Virus Induced Natural T Lymphocyte(EBViNT) Cell in Patients With Progressive EBV Positive Extranodal NK/T-cell Lymphoma Where Standard Treatments Have Failed (clinicaltrials.gov) - P1/2; N=28; Recruiting; Sponsor: Eutilex; Trial completion date: Dec 2020 ➔ Dec 2024; Trial primary completion date: Sep 2020 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Eutilex (263050) R&D momentum to grow stronger, corporate value rise (Maekyung Media Group) - "T-cell therapy AppB&T is in phase 1/2 clinical trial for patients with NK/T lymphoma...Patient administration is expected to begin in early 21st, and data is expected to be released in the second half...Researchers' clinical results will be presented at AACR (American Cancer Society) in April 21. WiT&T...is undergoing phase 1 clinical trials for patients with malignant brain tumors. The results are expected to be announced at the ASCO (American Society of Clinical Oncology) held in June 21. In addition, TAST, a next-generation T-cell therapy technology, is scheduled to apply for a phase 1 clinical trial IND in the second half of 21..."

Enrollment status • IND • New P1 trial • P1 data • P1/2 data • Brain Cancer • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma