Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, is pleased to announce 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) Annual Meeting.

This year's AACR 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 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.

About Gracell
Gracell Biotechnologies Co., Ltd. ("Gracell") is a clinical-stage biotech company, committed to developing highly reliable and affordable cell gene therapies for cancer. Gracell is dedicated to resolving the remaining challenges in CAR-T, such as high production costs, lengthy manufacturing process, lack of off-the-shelf products, and inefficacy against solid tumors. Led by a group of world-class scientists, Gracell is advancing FasTCAR™, TruUCAR™ (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.

CONTACT:

Linc HE
Business Development and Public Relations
Linc.he@gracellbio.com
+86-21-6403-1375

^[1] Pediatric hematologic Malignancies: T-cell acute lymphoblastic Leukemia, Hematology 2016
^[2] Progress and innovations in the management – JAMA Oncol 2018
^[3] Defining the course and prognosis of adults with acute lymphoblastic leukemia, Cancer 2010

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