On April 13, 2020 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, reported that their first-in-human phase I data of Universal TruUCAR GC027 in relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) was accepted for plenary oral presentation at the America Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Gracell Biotechnologies, APR 13, 2020, View Source [SID1234556271]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
This year’s AACR (Free AACR Whitepaper) presentations are moved to be held virtually to allow sharing the data in a timely fashion. A series of online sessions featuring presentations will be provided. Gracell will report the clinical safety and efficacy of GC027, an off-the-shelf CAR-T product based on Gracell’s TruUCAR technology, for treatment of adult T-ALL patients.
"We are very pleased that AACR (Free AACR Whitepaper) has accepted the phase I results of GC027, a first-in-human off-the-shelf TruUCAR product for plenary oral presentation. Gracell’s proprietary TruUCAR platform was protected with patents of novel designs and unique features. Remarkably, GC027 derived from HLA unmatched donor’s cells, is a monotherapy without co-administration of other immunosuppressive drug." said Dr. William CAO, founder and CEO of Gracell. "We are pleased to share the first-in-human phase I data with the scientific community."
Presentation: Safety and efficacy clinical study of TruUCART GC027: the first-in-human, universal CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia
Abstract #9564
Online live section: Apr. 27-28, EDT
About GC027
GC027 was manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR technology. TruUCAR allows the allogeneic CAR-T cells to proliferate and persist in HLA-unmatched patients (recipients) with minimized risk of graft-versus-host-disease (GvHD). GC027 is currently being developed as an investigational, off-the-shelf CAR-T cell therapy for treatment of T cell malignancies. The use of HLA unmatched healthy donor’s cells may improve efficacy and reduce production time, available for off-the-shelf use in a timely manner.
About TruUCAR
TruUCAR is Gracell’s proprietary and patented platform technology, with selected genes being edited to avoid GvHD and immune rejection without using strong immunosuppressive drugs. In addition to T-ALL antigen, the platform technology can also be implemented for other targets of hematological malignancies.
About T-ALL
T – Lymphoblastic Leukemia (T-ALL) is an aggressive form of acute lymphoblastic leukemia, with a diffuse invasion of bone marrow and peripheral blood. In 2015, T-ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide. T-ALL compromises about 15%-20% of all children and adult acute lymphoblastic leukemia[1]. Current standard of care therapies for T-ALL are chemotherapy and stem cell transplantation. 40-50% of patients will experience relapse within two years following front line therapy with limited treatment options available[2] [3]. Treatment of relapsed and refractory T-ALL remains a high unmet medical need.