On October 16, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK) announced that the company's independently developed humanized IgG1 CD24 antibody(Project number: IMM47) was approved by the National Medical Products Administration (NMPA) for clinical trials. This is another milestone achievement in the rapid development of ImmuneOnco.

IMM47 had also made a number of progresses previously by the efforts of the ImmuneOnco team. On September 27, the Australian phase I clinical trial of IMM47 successfully completed the enrollment of the first subject and officially entered the clinical research stage. The preclinical research results of the IMM47 project were published in "Antibody Therapeutics" on September 9. So far, IMM47 has obtained two authorized patents in China, and Japan, two pending patent applications in the United States and the European Union, and one pending patent application that may enter multiple approval of PCT patent of contracting countries in the future. In addition, we are ready to submit an IND application for IMM47 to the U.S. Food and Drug Administration (FDA) in near future.

CD24 is widely expressed in a variety of solid tumors including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, ovarian cancer, and lymphoma, and is considered as an important marker of poor prognosis in these cancers which exhibits great clinical research potential.

With high specificity and high affinity to CD24 expressed on tumor cells, IMM47 can block immunosuppressive signals transmitted from the CD24/Siglec-10 pathway to macrophages, natural killer cells (NK) and T cells. By genetically engineered improved IgG1 Fc, IMM47 effectively activates macrophage and natural killer cell immune responses through powerful ADCP and ADCC. In preclinical animal in vivo efficacy studies, IMM47 showed to significantly increase the number of M1 macrophages in tumor tissues and downregulate CD24 expression in tumor cells, which also provide chances in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs.

Dr. Tian, Wenzhi, founder and chairman of Immune Onco, said:

  "We are very pleased to see that our clinical trial application for IMM47, a humanized monoclonal antibody targeting CD24 for cancer treatment, was approved by the National Medical Products Administration (NMPA). The antibody screening for CD24 was quite challenging due to its small size of extracellular domain which exhibits weaker immunogenicity. We persevered through the accumulation of a lot of trivial work and finally got the IMM47 molecule with high affinity and specificity. With differentiated molecular design, IMM47 can specifically bind to CD24 and effectively activate macrophages and natural killer cell immune responses. Preclinical studies have shown that IMM47 has strong anti-tumor activity with great clinical development value. We will quickly advance the clinical trial of IMM47 to benefit more patients.”