Bioheng Announced Oral Presentation of Its Preliminary Results of CRISPR-Engineered Allogeneic CAR-T for r/r B-ALL Treatment at 2020 ASH Meeting
Nov. 10th, 2020 -- Bioheng Biotech Co., Ltd, a clinical-stage biotech company focused on developing novel cellular immunotherapy to treat cancer, today announced an oral presentation at 62th The data will be presented regarding the pre-clinical development, manufacturing, and IIT clinical results of the company’s lead product, CTA101, a CRISPR-Cas9-engineered off-the-shelf CD19/CD22 dual-targeted CAR T cell product, in patients with relapsed / refractory B-cell acute Lymphoblastic Leukemia.
“CTA101, a CRISPR-engineered allogeneic dual-targeted CAR-T, has showed manageable safety and promising efficacy in the treatment of r/r B-ALL patients,” said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. “It has preliminarily verified the feasibility of generating allogeneic CAR-T by CRISPR gene editing and provided evidence for extended application in the future. As an allogeneic CAR-T, CTA101 tackles several limitations associated with conventional CAR-T therapy, such as possible manufacturing failures, undesirable waiting period between leukapheresis and CAR-T infusion, poor product consistency due to bespoke manufacturing process for individual patient, and unaffordable cost. In addition, its dual-targeted design may be a viable solution to reduce the relapse rate of B-ALL. I would like to expect more allogeneic CAR T cell products for clinical use, which certainly provide more choices to address the unmet medical needs.”
Oral Presentation
Title: 499 The Safety and Efficacy of a CRISPR/Cas9-Engineered Universal CAR-T Cell Product (CTA101) in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Session: 801. Gene Editing, Therapy and Transfer I
Date: Sunday, December 6, 2020
Time: 2:30 p.m. ET (11:30 a.m. PT)
https://ash.confex.com/ash/2020/webprogram/Paper142262.html
“We are looking forward to sharing preliminary feasibility, safety and efficacy data from our first CRISPR-based allogeneic CAR T cell product, CTA101, at the ASH 2020 annual meeting,” said Lu Han, CEO of Bioheng Biotech. “Our team is dedicated to the research and development of allogeneic CAR T cell products. These endeavors and valuable insights, together with the positive clinical results will further advance our improvement on our CAR T cell pipelines.”
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On May 16, 2024, Bioheng Therapeutics (referred to as "Bioheng"), an innovative biopharmaceutical company focusing on the development and commercialization of Universal Chimeric Antigen Receptor T-cell (UCAR-T) products, announced today that it will present the Phase I clinical data of its CD7-targeted Universal CAR-T cell product, RD13-02, for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) patients at the 29th European Hematology Association (EHA 2024) Annual Congress, to be held in Madrid, Spain, from June 13 to 16, 2024, in the form of an academic poster.
On April 25, 2024, The New England Journal of Medicine published the latest findings by the team of He Huang, M.D., PhD., and Yongxian Hu, M.D., PhD., from the First Affiliated Hospital, Zhejiang University School of Medicine, titled "Sequential CD7 CAR-T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis"[1]. The study introduces an innovative treatment strategy that combines CD7 CAR-T with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the first time.
Bioheng Received CDE IND Approval for CTA101 UCAR-T
On March 17,2022, China National Drug Administration Drug Review Center ( CDE ) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug ( Acceptance No. : CXSL2101509 ) . CTA101 is independently developed by Nanjing Bioheng Biotech Co., Ltd ( hereinafter referred as ' Bioheng), targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ).
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