Bioheng Announced Oral Presentation of Its Preliminary Results of CRISPR-Engineered Allogeneic CAR-T for r/r B-ALL Treatment at 2020 ASH Meeting

Reprint to:

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)


“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.”

Related News

Bioheng's CD7 UCAR-T and Allogeneic HSCT Sequential Therapy Study Published in the New England Journal of Medicine

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 ).

Bioheng‘s Auto CAR-T Product, CTB001, Received Orphan Drug Designation (ODD) from the U.S. FDA

Recently, Bioheng Biotech Co., Ltd ( hereinafter referred to as ' Bioheng) announced that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation ( ODD ) from the Food and Drug Administration ( FDA ) for the treatment of gastric cancer. Gastric cancer has a high incidence in Asian countries such as China and Japan, and the mortality rate ranks the third in the global mortality rate of malignant tumors, behind lung cancer and colorectal cancer. At present, conventional chemotherapy and surgical resection are mainly applied for the gastric cancer treatment, therefore the treatment drugs and methods are very limited.

Bioheng Received Orphan Drug Designation(ODD) from the U.S. FDA for the Treatment of T-ALL

Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL).

Bioheng Raised $80 Million in Series B Financing to Advance Allogeneic Immuno-Cell Therapies

NANJING, China, March 24, 2021 /PRNewswire/ -- Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company  dedicated on developing novel cellular immunotherapy for cancer, today announced that it had secured $80 million in Series B Financing. The Series B was co-led by GL Ventures, the venture capital unit of Hillhouse Capital, Decheng Capital and Octagon Capital, with the participation of BlueRun Ventures China and Shenzhen Capital Group Company.

Contact Us