Gracell to Present the First-in-human, Universal TruUCAR™ GC027 Therapy for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR Annual Meeting

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 Am

SUZHOU, China and SHANGHAI, April 13, 2020 /PRNewswire/ -- 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.

Gracell Logo (PRNewsfoto/Gracell)

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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