Bioheng Announced Oral Presentation of Its Preliminary Results of CRISPR-Engineered Allogeneic CAR-T for r/r B-ALL Treatment at 2020 ASH Meeting
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2020-11-13
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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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June 1, 2025 , Bioheng Therapeutics, an innovative biopharmaceutical company focused on the development and commercialization of cell therapies, presented results from an investigator-initiated trial (IIT) of RD06-03, its allogeneic anti-CD19 CAR-T therapy for relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
February 28, 2025 – Bioheng Therapeutics US LLC (“Bioheng”), a clinical-stage biopharmaceutical company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development.
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