HANGZHOU and NANJING, China I November 10, 2020 I Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company focuses on developing novel cellular immunotherapy, today announced that their preliminary data including the pre-clinical development, manufacturing, and investigator initiated trial (IIT) results for CTA101, a CRISPR/Cas9-engineered off-the-shelf CD19/CD22 dual-targeted CAR-T cell product, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually on December 5-8, 2020. The study was designed to evaluate the feasibility of CTA101 in patients with relapsed/refractory B-cell acute Lymphoblastic Leukemia (r/r B-ALL).

“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 initial data on the feasibility, safety and efficacy of our first allogeneic CAR T cell product, CTA101, at the ASH 2020 annual meeting,” said Xiaohong He, PhD, CEO of Bioheng Biotech. “CTA101 is based on our first-generation allogeneic CAR T technology platform, which can be timely infused to patients without HLA matching. Bioheng has always been committed to the development and commercialization of allogeneic CAR-T cell technologies and products. The positive results of CTA101 will further promote the development and translation of our multiple allogeneic CAR T pipelines.”

About Bioheng

Bioheng is a leading clinical-stage biotech company focusing on the development of novel allogeneic cellular immunotherapy for immediate treatment of patients with hematologic and solid tumors. Allogeneic CAR-T may significantly increase the affordability and accessibility through overcome the obstacles encountered by autologous CAR-T. Currently, Bioheng has established a pioneering allogenic immunotherapy platform and built a 55,000 square feet high standard GMP-level R&D and translational center. https://www.bioheng.com/en/index.php/welcome.html

SOURCE: Bioheng Biotech