On July 15, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) announced that the first global CD47×HER2 bispecific molecule (IMM2902) have received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for breast cancer. The grant of FTD by the US FDA is a major affirmation to IMM2902.

After the drug candidate IMM2902 under development is granted the FTD status, the company will have more opportunities to communicate with the US FDA in the process of clinical trial and review. It is expected to be able to discover and solve problems in research and development in a timely manner, which will help to speed up clinical research and approval of the drug.

Preclinical studies demonstrate that IMM2902 exhibits robust anti-tumor activity in several breast and gastric tumor models, including HER2-expressing low and trastuzumab-resistant tumor models. We are conducting a Phase Ia/Ib clinical trial in China to evaluate the efficacy of IMM2902 in advanced HER2-positive and HER2 expressing-low solid tumors, including breast cancer, gastric cancer, non-small cell lung cancer and cholangiocarcinoma. The first patient was dosed in February 2022. We also initiated a clinical trial in advanced HER2-positive and HER2-expressing-low solid tumors in the United States, the first patient was dosed in June 2022.

Chairman and founder of ImmuneOnco, Dr. Tian, Wenzhi is full of confidence in the clinical research of IMM2902. He said:

"We are highly inspired that our IMM2902 has been granted Fast Track designation for breast cancer by the U.S. FDA. IMM2902 is a bi-specific molecule for targets CD47 and HER2 developed based on our own R&D platform. The high affinity of the molecule allows it to preferentially bind to tumor cells. At the same time, it doesn’t bind to human erythrocytes so as avoiding the 'antigen sink effect' thus greatly enhancing the specific synergistic effect of two targets against tumors. Although HER2 antibody-drug conjugates (ADCs) have shown activity in certain HER2-low-expressing tumors in clinical trials, they are often associated with serious adverse reactions such as interstitial pneumonitis and even death, which bring potential risks to patients. We believe that the similar efficacy and better safety profiles demonstrated by IMM2902 will make it valuable in clinical development and commercial potential."