VT-Tri(1)-A / Boryung Group - LARVOL DELTA

Vigencell, ICBMT, 3 research results abstracts accepted including oral presentations [Google translation] (Pharm News) - "Vigencell...announced on the 20th that it will hold one oral presentation and two poster presentations along with abstract adoption at the International Conference of the Korean Society for Blood and Marrow Transplantation...to be held in September...Vigencell will present that the administration of VT-Tri derived from donors after hematopoietic stem cell transplantation (HSCT) is safe and can be a good treatment option for patients with relapsed or refractory AML...first poster presentation will present the results of a study...The study compared the efficacy of CAR-T cells with CD30-derived signaling domains with conventional CD28, 4-1BB CAR-T cells in an animal model of blood cancer, and CAR-T cells with CD30-derived signaling domains showed better performance in survival rate and body weight maintenance than conventional CAR-T cells in animal experiments....it was confirmed that γδ T cells stimulated with aAPCs showed long-term proliferation and enhanced cell activation..."

Clinical data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

ViGenCell begins enrolling patients for P1 trial of AML drug (Korea Biomedical Review) - "ViGenCell said Monday that it had initiated the Cohort 3 study, the final step of the phase 1 clinical trial of VT-Tri(1)-A for treating acute myeloid leukemia (AML)....As in Cohort 1, the company said there were no treatment-related serious adverse events or dose-limiting toxicities (DLTs) in all patients treated in Cohort 2. It added that in Cohort 3, the number of doses per patient will increase to four, and the trial will be conducted at seven medical institutions, including the Catholic University of Korea Seoul St. Mary's Hospital."

Trial status • Acute Myelogenous Leukemia

ViGenCell wins nod to change its manufacturer for AML treatment (Korea Biomedical Review) - "ViGenCell said Wednesday that it has obtained approval from the Ministry of Food and Drug Safety (MFDS) to change the manufacturing source for its investigational new drug product, VT-Tri(1)-A, for acute myeloid leukemia (AML). With the approval of the manufacturing source change for VT-Tri(1)-A, ViGenCell has changed the registering of its clinical trial drug manufacturing site for VT-Tri(1)-A from the Catholic Institute of Cell Therapy GMP to ViGenCell's state-of-the-art biopharmaceutical GMP center....The company added that it will also help reduce ancillary costs and accelerate and streamline clinical trials."

Commercial • Acute Myelogenous Leukemia

ViGenCell’s AML drug wins nod for compassionate use (Korea Biomedical Review) - "ViGenCell...said the Ministry of Food and Drug Safety has granted compassionate use approval for VT-Tri, an acute myeloid leukemia (AML) treatment....'We will continue to conduct clinical research on VT-Tri to provide new treatment options to patients and their families suffering from AML'."

Non-US regulatory • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology