On June 20, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) reported 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) (Press release, ImmuneOnco Biopharma, JUN 20, 2022, View Source [SID1234655662]). The first subject has been enrolled and dosed in the United States, and the infusion went well without any complications.
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IMM2902 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."