Gracell Reports Data of First-in-human Clinical Trial for Universal TruUCAR(TM) GC027 in Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR Virtual Annual Meeting

SUZHOU, China and SHANGHAI, April 28, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, has announced data of its first-in-human clinical trial for Universal TruUCAR(TM) GC027 in relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) patients. The data was presented in the Adoptive Cell Transfer Therapy section during the American Association for Cancer Research (AACR) Virtual Annual Meeting held on April 28.

T-ALL, a form of acute lymphoblastic leukemia, consisting of 20-25% of adult ALL, and 12-15% of pediatric ALL, represents a hard-to-treat disease with a high unmet clinical need.([1]) Outcome of relapsed and refractory T-ALL remains poor, with very limited treatment options available. Most T-ALL patients relapse within two years after multi-agent chemotherapy regimens. The study of TruUCAR(TM) GC027 in relapsed and refractory T-ALL reports early efficacy outcomes of five patients treated in this area of high unmet medical need.

The clinical investigator initial trial (IIT) intends to evaluate safety and efficacy of TruUCAR(TM) GC027, the first-in-human, universal CAR-T therapy for R/R T-ALL. As of February, the study enrolled a total of five patients with R/R T-ALL, with median prior lines of therapy 5 (range 1-9). Baseline bone marrow tumor burden was 38.2% (range 4-80.2). All patients received a single infusion of TruUCAR(TM) GC027 in one of three dose levels: 0.6*10^7cells/kg, 1.0*10^7cells/kg or 1.5*10^7cells/kg. Notably, these patients were not HLA matched, and no one accepted post-infusion hematopoietic stem cell transplantation (HSCT).

Treatment efficacy was assessed in five patients with 28 days of follow-up, of which:

    --  Five (100%) achieved a complete remission with or without complete blood
        count recovery (CR/CRi);
    --  Four (80%) achieved minimum residual disease negative complete remission

All five patients tolerated the single infusion of TruUCAR(TM) GC027 with no neurotoxicity events or acute graft-versus-host disease (aGvHD) observed. Cytokine release syndrome (CRS) presented in all patients at any grade.

"We are delighted to report the outcome on the first five patients treated with TruUCAR(TM) GC027. These promising preliminary results are encouraging and warrant further evaluation of the therapy in this area of high unmet clinical need." said Dr. Martina Sersch, CMO of Gracell.

About TruUCAR(TM)

TruUCAR(TM) 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

GC027 is 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(TM) technology, which is expected to improve efficacy and reduce production time, available for off-the-shelf use in a timely manner.

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([2]). 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([3][4]). 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(TM), TruUCAR(TM) (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.


Linc HE
Business Development and Public Relations

                        [1] Pediatric hematologic
                         Malignancies: T-cell acute
                         lymphoblastic Leukemia,
                         Hematology 2016

                                      hematologic Malignancies: T-cell
                                      acute lymphoblastic Leukemia,
                                      Hematology 2016

                        [3] Progress and innovations in
                         the management - JAMA Oncol 2018

                        [4] Defining the course and
                         prognosis of adults with acute
                         lymphoblastic leukemia, Cancer

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