Innolake Bio's Universal Dual-Targeting Antibody-Conjugated NK Cell Therapy IBR733 Receives IND Approval in China for Relapsed/Refractory AML

Dec 20, 2023 10:26 CST Updated 10:26

iMBioRay

CAR-NK Cell Therapy Drug Developer

On December 18, 2023, Imbioray (Hangzhou) Biopharmaceutical Co., Ltd. ("Imbioray") announced that its original innovative antibody-conjugated cell therapy product "IBR733 Cell Injection" (acceptance number CXSL2300643) has officially received the New Drug Clinical Trial (IND) approval notice (Notice No.: 2023LP02585) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

IBR733 Cell Injection is the world's first IND-approved clinical research CD33 and CLL1 dual-target antibody-conjugated NK product for the treatment of relapsed or refractory acute myeloid leukemia (AML). It utilizes Imbioray's proprietary tumor antigen-targeting specific antibody, CD33/CLL1, which is chemically covalently conjugated to NK cells via a linker. This off-the-shelf, universal NK cell product does not involve viral vectors or genetic modification, offering high safety and potent tumor cell-killing ability.

Acute Myeloid Leukemia (AML) is a malignant disease of myeloid hematopoietic stem/progenitor cells. The disease progresses rapidly, with severe conditions and poor prognosis. AML has always been one of the treatment challenges among hematologic malignancies, lacking effective therapeutic options. For decades, chemotherapy has dominated drug treatments for AML, with a 5-year survival rate below 20%. Despite advances in cytogenetics and molecular biology, which have deepened the understanding of the underlying pathogenic mechanisms of AML and promoted the development of targeted therapies for AML, targeted drugs have limited applicability and show only modest improvements in overall survival. Most patients experience post-treatment relapse or bone marrow suppression.

Clinical sample studies have shown that 90% of tumor tissues in AML patients express CD33, but it is either not expressed or lowly expressed in normal tissues; most AML CD34+CD38- stem cells express CLL1, while those in healthy individuals do not. CLL1 is a marker antigen of leukemia stem cells and has potential value for targeted therapy. Imbioray's IBR733 is an off-the-shelf universal conjugated antibody CD33/CLL1 dual-target NK cell product. By targeting CD33 and CLL1, it can simultaneously attack AML cells and leukemia stem cells, the latter being the main factor leading to AML recurrence. This approach can effectively improve the efficacy of AML treatment while reducing the safety risks associated with single-target therapies and tumor immune escape.

We would like to express our gratitude again to CDE for the recognition of our product. IBR733 Cell Injection is the second antibody-conjugated NK cell therapeutic product with independent intellectual property rights approved by Imbioray for IND.Imbioray has established clinical strategic partnerships with renowned hospitals in China, such as the First Affiliated Hospital of Soochow University, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, the First Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University, and Zhongda Hospital Affiliated to Southeast University. After obtaining the IND approval, Imbioray will initiate a pivotal clinical study for the treatment of acute myeloid leukemia at these prestigious clinical institutions in the first quarter of 2024. As the world's first CD33/CLL1 dual-targeting NK cell product to enter the pivotal clinical stage, it is expected to bring new therapeutic options and survival hope to more patients with AML.

About Imbioray

Dr. Zhenwei Miao, Founder and Chairman of ImbiorayAs a global leader in ADC and a renowned expert in the field of antibody-conjugated NK cells, applying ADC strategies to develop antibody-conjugated NK cell products.Imbioray is dedicated to addressing unmet clinical needs in the fields of oncology, immunological diseases, chronic conditions, and non-oncological neurological disorders.Mainly Focus on the Global FrontierNKDevelopment and Clinical Application of Cell Therapeutic Drugs and Cell Connector Products.Imbioray has an internationally original tiNK and antibody-conjugated NK cell technology platform, with advanced processes for large-scale in vitro closed automated culture of NK cells that are internationally leading. Based on its proprietary platform technology, it has developed IBR854.IBR733、IBR822、IBR900And multiple universal off-the-shelf cell therapy products targeting solid tumors and hematological malignancies have been evaluated in several investigator-initiated clinical trials (IITs), which preliminarily demonstrated excellent safety and efficacy. CurrentlyIBR854 Cell Injection has progressed to Phase I clinical trials.IBR733 Initiated Phase I Registration Clinical Trial in the First Quarter of 2024IBR822 is expected to submit the IND application in December 2023.Multiple new drugs for solid tumors and hematological malignancies are being progressively advanced.