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ImmuneOnco received FDA approval of IMM2902 as an Investigational New Drug (IND) in the United States
2021-08-21
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August 21, 2021, Shanghai, China. ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") declared that the U.S. Food and Drug Administration (FDA) has granted permission to IMM2902, a bi-specific antibody-receptor recombinant protein targeting Human CD47xHER2 for HER2-expressing advanced solid tumors for the Investigational New Drug (IND) application in the United States.


By targeting both CD47 and HER2, IMM2902 is one of the best drug candidates under global clinical researches. IMM2902 project was previously approved by the National Drug Products Administration (NMPA) in China on June 29, 2021, and it is one of three new drug candidates based on CD47 to enter the clinical study. Permission to enter clinical study of IMM2902 by FDA is another important milestone for the company to develop global market.


"We are very pleased to receive FDA approval for the IMM2902 IND in the United States." said Dr. Wenzhi Tian, the founder of ImmuneOnco. “IMM2902 is a bi-specific molecule for CD47 and HER2 developed based on our mAb-Trap technical platform. Through the high affinity to HER2, this molecule preferentially bind to tumor cells. The product has a unique feature that it doesn’t bind to human red blood cells to form ‘Antigenic sink’, thus greatly enhancing the specific synergistic effect of the double targets against tumor. We believe IMM2902 has promising developmental value and huge commercial potential." Dr. Tian is quite confident about the prospects of IMM2902 clinical development.