Gracell Announces Two Presentations at the Annual Meeting of American Society of Clinical Oncology (ASCO)

SUZHOU,China and SHANGHAI,May 29,2020 -- Gracell Biotechnologies Co.,Ltd. ("Gracell"),a clinical-stage immune cell and gene therapy company,today announced that two presentations were accepted at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.

Both presentations can be found in the Development Therapeutics – Immunotherapy session,central on Gracell's TruUCAR™ GC027 in relapsed or refractory T-cell acute lymphoblastic leukemia (r/r T-ALL) patients and EnhancedCAR GC008t in patients with advanced mesothelin-positive solid tumors.

"We are delighted to report on both TruUCAR™ GC027 in T-ALL and EnhancedCAR GC008t in solid tumors" said Dr. Martina Sersch,CMO of Gracell. "and glad to share safety and preliminary efficacy data on two of our exciting new CAR-T platform therapies with the scientific community at the ASCO annual meeting." Dr. William CAO,CEO of Gracell,added "Thanks to our highly efficient gene editing capability,CAR-T cells with PD-1 gene edited are generated to have enhanced capability of tumor control in inhibitory tumor microenvironment. We believe this strategy will improve CAR-T/TCR-T's potency against solid tumors.Gracell carried out this strategy as early as 2017,upon our foundation. With two years' preclinical and clinical investigations,we are very glad to see it showing first encouraging results in an effort to enhance CAR-T cells to combat solid tumors".

Session type: poster discussion

Abstract Title: Safety and efficacy results of GC027: The first-in-human,universal CAR-T cell therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL)

Abstract ID: 3013

Link: https://meetinglibrary.asco.org/record/185068/poster

Session type: poster

Abstract Title: Phase I study of CRISPR-engineered CAR-T cells with PD-1 inactivation in treating mesothelin-positive solid tumors

Abstract ID: 3038

Link:https://meetinglibrary.asco.org/record/189057/poster

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 GC027

GC027is an investigational,off-the-shelf CAR-T cell therapy,redirected to CD7 for the treatment of T cell malignancies. GC027 was manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR™ technology,which is expected to improve efficacy and reduce production time,available for off-the-shelf use in a timely manner.

About EnhancedCAR

EnhancedCAR is Gracell's proprietary and patented platform technology,with selected genes edited to enhance immune cell performance in terms of killing efficiency,in vivo persistence,including selected PD-1 and TCR mediations. The technology can be implemented to many other targets with high editing precision and efficiency.

About GC008t

GC008t is an investigational,autologous CAR-T cell therapy,redirected to mesothelin with PD-1 disruption for the treatment of mesothelin-positive solid tumors. With PD-1 knocking out,GC008t is expected improve persistence and clinical efficacy.

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 Mesothelin-positive Solid Tumors

Mesothelin,a cell surface antigen,has high expression to a broad spectrum of solid tumors while express low levels on normal cells. Mesothelin is believed as a good target for multiple solid tumors. The GC008t study enrolled patients with advanced solid tumors,including pancreatic cancer,ovarian cancer,and colorectal cancer,of which clinical outcome of standard of care remains poor.

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),DualCAR and EnhancedCAR-T cell therapies for leukemia,lymphoma,myeloma,and solid tumors.

[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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