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IMM0306 project of ImmuneOnco has been approved by FDA

Date:2021-01-09 Views:691

On January 9, 2021, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the company's self-developed bispecific antibody drug (Project No.: IMM0306) targeting both CD47 and CD20 has obtained the US FDA clinical trial research license. It was only 30 days before the application for IND was submitted to FDA that the company obtained the clinical trial research license, which indicated that the company team had made excellent preparation for CMC and clinical research protocol, and laid a good foundation for many projects to apply for IND in the United States in the future. In addition to a number of clinical trials in China, the first project of ImmuneOnco was approved by FDA, which is another major milestone in the development of the company.



"We are very glad to see that our IMM0306 project has successfully obtained the US FDA clinical trial research license, which marks the recognition and expectation of the world's top market like the United States for our independent innovation project. IMM0306 is an antibody receptor recombinant protein (mAb-Trap) that targets both CD47 and CD20. It is the first bispecific target molecule of CD47xCD20 to enter clinical trials in the world. IMM0306 is not combined with human red blood cells, and its efficacy is significantly better than that of Rituximab at the same dose. It is hopeful to replace Rituximab as the first-line treatment option for patients with B-cell lymphoma in the future. At present, the clinical phase I trial of the project in China is progressing smoothly, and we are full of expectations for the future of IMM0306. " Dr. Tian Wenzhi, founder and chairman of ImmuneOnco, is full of confidence in the clinical trial of IMM0306. "We will continue to expand the clinical trial of IMM0306 project to benefit more subjects. At the same time, we will speed up the listing of IMM0306 to benefit cancer patients as soon as possible. ".


About IMM0306

IMM0306 is an antibody receptor recombinant protein (mAb-Trap) targeting CD47 and CD20 at the same time. It is the first in class in the world. It is a bispecific antibody drug with independent intellectual property rights of ImmuneOnco. It can act on tumor disease targets and regulate immune system at the same time, and exert strong anti-tumor effect by activating macrophages and NK cells.


About ImmuneOnco

ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. was founded in June 2015 and registered in Zhangjiang High Tech Park, Shanghai. The company is mainly committed to the development and research of tumor immunotherapy products, including bispecific antibodies, new recombinant proteins, and TANKTM cell therapy. The common feature of our products is to stimulate and mobilize the immune system of patients to play an anti-tumor effect, and ultimately inhibit the continued growth of tumor cells, reverse a series of malignant symptoms caused by this, so that patients gradually return to a healthy state of the body.

Contact us

Address: Room 502, 1043 HaLei Road, Pudong New Area, Shanghai, China

                Building 7, Lane 908, Ziping Road, Pudong New Area, Shanghai, China

Tel. + 86 21 5835 6573

website: www.immuneonco.com