On September 27, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK) announced that the newly developed humanized IgG1 CD24 antibody, IMM47, successfully completed the first subject enrollment and dosing in the Australian phase I clinical trial. This is another milestone achievement in the company's rapid development.

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 an important biomarker of poor prognosis in these cancers. And it appears to be great potential in clinical research.

With high specificity and high affinity binding 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. With genetically engineered improved IgG1 Fc, IMM47can also effectively activates macrophage and natural killer cell immune responses through powerful ADCP and ADCC. In preclinical animal in vivo efficacy studies, IMM47 was shown to significantly increase the number of M1 macrophages in tumor tissues and downregulate CD24 expression in tumor cells, either alone or in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs. Both combinations have shown encouraging abilities to inhibit tumor growth.

In addition, the IND application for IMM47 to treat solid tumors has been accepted by the National Medical Products Administration (NMPA), and we also plan to submit an application to the U.S. Food and Drug Administration (FDA) in the near future. IMM47 has obtained an authorized patent in China, an approved patent application in Japan, a pending patent application in the United States and the European Union, and a pending PCT patent that may enter multiple signatory countries in the future.

The preclinical research results of the IMM47 have been published in "Antibody Therapeutics" on September 9, 2023, in tittle of "IMM47, a humanized monoclonal antibody that targets CD24, exhibits exceptional anti-tumor efficacy by blocking the CD24/Siglec-10 interaction and can be used as monotherapy or in combination with anti-PD1 antibodies for cancer immunotherapy”

Founder and Chairman of ImmunOnco, Dr. Tian, Wenzhi said: "I am very pleased to see that our Australian phase I clinical trial of IMM47 has successfully completed the first subject enrollment and dosing. This also marks that IMM47 has officially entered the clinical research stage. IMM47 is a humanized monoclonal antibodies targeting CD24 for cancer treatment. The antibody screening for CD24 was quite challenge 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.”

Chief Medical Officer/Senior Vice President of ImmuneOnco Dr. Lu, Qiying said: "the successful completion of the first subject in the Australian Phase I clinical trial of IMM47 is of great significance for the company, marking that IMM47 officially entered the clinical research.  After half year of unremitting efforts by the clinical team, ImmunOnco launched clinical trials in Australia, the first drug candidate for this target to achieve FPI globally. This is due to our first overseas deployment, thus accelerating the clinical verification of IMM47. In addition, we believe that the Australian trial will obtain valuable diverse ethnic clinical data. It will strengthen our ability to pursue collaborating opportunities with global pharmaceutical companies. We highly expect IMM47 drugable and look forward to bringing good news to cancer patients."