Clinical trial study on expanding new indications of IMM01 project
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the first Fc fusion protein drug targeting human CD47 (project number: IMM01) in China was accepted by NMPA for clinical trial application (IND) for new indications (MM, AML and MDS). This is another milestone of ImmuneOnco continuing efforts in the research and development of CD47 targeted drugs, which further establishes the leading echelon position of ImmuneOnco in the research and development of CD47 targeted drugs.
IMM01 is being promoted for the treatment of relapsed / refractory lymphoma (NHL)& In the phase I clinical study of HL patients, we have nearly completed the enrollment of subjects with all doses in the original plan. Except for a few patients with mild transfusion reactions, no dose limiting toxicity (DLT) and no anti-drug antibody (ADA) have been found. At the same time, some patients still have exciting curative effect reactions. The data will be released at next year's academic conference.
The full activation of macrophages depends on two basic conditions: 1) blocking the "don't eat me" signal (CD47-SIRPa); 2) activating the "eat me" signal. If it is IgG4, the macrophages can’t be fully activated because it can’t activate the "eat me" signal well, so the single drug is basically ineffective.
IMM01 is a IgG1 Fc fusion protein, which can block the "don't eat me" signal and activate the "eat me" signal, so it has a strong phagocytic effect and a strong anti-tumor effect in vivo. The experimental results show that if the Fc effect function is removed, IMM01 will lose its antitumor effect.
After analysis of hundreds of blood samples, it was found that IMM01 did not bind to human red blood cells, even at concentrations up to 5000nM. Studies by foreign companies have found that CD47 of human erythrocytes is mainly distributed in non soluble regions, which leads to the lack of mobility of CD47 on erythrocyte membrane, so it does not bind with SIRPa-Fc. Our recent study found that the glycosylation of CD47 on red blood cells completely blocked the binding of IMM01 to red blood cells. If red blood cells were treated with PNGase f to remove the glycosylation of CD47, the binding of IMM01 to red blood cells could be restored.
"We are very glad to see that our application for clinical research on new indications of IMM01 project has been accepted. In the phase I clinical trial, the IMM01 project has obtained exciting experimental data in a lower dose range, which is due to the differentiated design of IMM01 itself. IMM01 does not bind to human red blood cells at all, avoids "antigenic sink", has no ADA, has small molecule (half of antibody), and has good tissue permeability and bioavailability. Therefore, we believe that IMM01 will have great clinical development advantages. " Dr. Tian Wenzhi, founder of ImmuneOnco, is confident in the clinical trial of IMM01, "we hope to continue to expand the research on new indications and combination drugs of IMM01 project in the future, so as to benefit more subjects. We will accelerate the clinical trial research of IMM01 and speed up the marketing of IMM01, so as to benefit cancer patients as soon as possible.
IMM01 project for injection is a new generation of immune checkpoint inhibitors with independent intellectual property rights, which is based on the "mAb-Trap" technology platform of ImmuneOnco. Aiming at the immune regulatory target CD47, it can activate the phagocytosis of tumor cells by macrophages, and present the phagocytized tumor antigen to T cells, so as to play a powerful tumor immunotherapy effect. IMM01 project perfectly solves the core pain points of CD47 target drug research and development, and has been granted invention patents in China, Japan and the United States respectively.
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. was founded in June 2015 and registered in Zhangjiang High Tech Park, Shanghai. The company is mainly committed to the development and research of tumor immunotherapy products. The product line mainly includes bispecific antibody, new recombinant protein, and TANKTM cell therapy. The common feature of our products is to stimulate and mobilize the immune system of patients to play an anti-tumor effect, and ultimately inhibit the continued growth of tumor cells, reverse a series of malignant symptoms caused by this, so that patients gradually return to a healthy state of the body.
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