Phase I clinical trial of IMM2902 completed the first patient enrollment and dosing in the United States.
On June 21, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) announced that, on June 20, local time, an FDA-registered Phase I clinical trial of the first globally novel bi-specific antibody-receptor fusion protein targeting human CD47xHER2（IMM2902) completed the first patient in (FPI). The first subject has been enrolled and dosed in the United States, and the infusion went well without any complications.
MM2902 is a CD47xHER2 bispecific fusion protein in the most cutting-edge of global research field for solid tumors. It was previously approved by the U.S. Food and Drug Administration (FDA) for clinical trials on August 21, 2021. It is the third CD47-based new drug projects in the clinical research stage of the company. On February 15, 2022, IMM2902 completed the first subject enrollment and dosing in China, and the clinical trial is progressing well. On June 16, the invention patent of the IMM2902 was authorized by the US Patent Office. The completion of the first patient enrollment and dosing of IMM2902 in the United States is another major milestone for the company!
Founder, Chairman and CEO of ImmuneOnco Dr. Tian, Wenzhi, said:
"We are very pleased that our IMM2902 program has completed the first patient enrollment and dosing in clinical studies in the United States. IMM2902 is a bispecific molecule targeting CD47 and HER2 developed based on our mAb-Trap technology platform. The high affinity to HER2 enables the drug to bind to tumor cells preferentially without binding to human erythrocytes and avoiding the "antigen sink effect", thus greatly enhancing the specific synergistic effect against tumors. Although Her2-related ADC drugs have excellent clinical performance, the unavoidable serious toxic and side effects (such as the incidence of interstitial pneumonia as high as 9% and the fatality rate as high as 2.6%) also bring greater risks to patients. We believe that, on the premise of ensuring similar efficacy, IMM2902 will greatly improve clinical safety. We truly believe that IMM2902 has great value for further clinical development.’ Dr. Tian is quite confident about the prospects of IMM2902 in clinical development.
IMM2902 is a new-generation bispecific drug candidate with global proprietary intellectual property rights, developed based on ImmuneOnco "mAb-Trap" technical platform. IMM2902 targets immune regulatory target CD47 and HER2, to inhibit tumor cell growth by accelerating the endocytosis and degradation of HER2, and to disinhibit and enhance the phagocytosis of macrophages against tumor cells by blocking the "don't eat me" signal mediated by CD47-SIRPα and activating the "eat me" signal mediated by Ig1Fc-FcγR. By the phagocytosis, processed tumor antigen was presented to T cells thereby exerting a powerful effect of tumor immunotherapy. IMM2902 is expected to be used mainly for HER2-expressing advanced solid tumors such as breast cancer, stomach cancer and lung cancer.