YingBaiRui's Allogeneic CAR-raNK Cell Therapy IBR733 Receives IND Approval from China NMPA for Relapsed/Refractory AML

Sep 25, 2023 08:26 CST Updated 08:26

iMBioRay

CAR-NK Cell Therapy Drug Developer

Recently, the clinical trial application for Imbioray's IBR733 Cell Injection has been accepted by the National Medical Products Administration (Acceptance No.: CXSL2300643). IBR733 Injection is a Class I biological product independently developed by Imbioray. It is an allogeneic, peripheral blood-derived, off-the-shelf CAR-raNK cell product indicated for Relapsed and Refractory Acute Myeloid Leukemia (r/r AML). After resubmitting the IND application using the latest closed automated process, Imbioray's application was accepted.

AML, a malignant hematological tumor, traps patients in a dire situation of uncontrolled proliferation of bone marrow blasts, causing normal hematopoietic function to fail, blood cell counts to plummet, and life to hang by a thread. The conditions of AML patients vary greatly with significant individual differences, presenting numerous challenges for treatment. Some fortunate patients manage to prolong their lives through intensive chemotherapy and/or hematopoietic stem cell transplantation; however, others respond poorly to existing treatments, leading to rapid deterioration and loss of life within just a few months. Particularly concerning are those with relapsed or refractory acute myeloid leukemia, most of whom are high-risk patients with limited current treatment options and heartbreakingly short survival times. There is an urgent need for new breakthrough therapies to bring hope and extend the lives of these patients.

IBR733 Injection is a globally innovative product developed by Imbioray that combines a CD33/CLL1 bispecific antibody with NK cell conjugation. Both its product structure and treatment method are internationally pioneering, marking a significant milestone. Results from investigator-initiated clinical trials (IIT) conducted by Imbioray show that IBR733 Injection is highly effective and very safe, offering new hope for AML patients.

Imbioray Core Team in CreationWith over 20 years of research experience in new drug development and clinical translation. Dr. Zhenwei Miao, the founder and CEO, has extensive industrial drug R&D experience, holding key positions in multiple Nasdaq-listed companies. He served as the Chief Scientist at Enanta, Senior Director of Chemistry at Ambrx, and Chief Technology Officer at Sorrento, successfully advancing several blockbuster products into clinical trials and obtaining regulatory approval for marketing. Dr. Shizhou Liu, the Chief Medical Officer, has many years of clinical and research experience at Massachusetts General Hospital of Harvard University, the Danish Cancer Society, and the Royal Academy of Engineering in the UK. Later, he became a dual-appointed Principal Investigator (PI) at the Translational Medicine Institute of Zhejiang University and the First Affiliated Hospital of Zhejiang University. He led the clinical development of multiple drugs at Boehringer Ingelheim, Johnson & Johnson, and CrownBio Apollomics.

Source: Official Account "Cell Gene Therapy"Imbioray, etc.

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