Phase II clinical trial application of ImmuneOnco: IMM0306 combined with lenalidomide for relapsed and refractory non-Hodgkin's lymphoma was accepted by NMPA
On November 18, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced that the independently developed bispecific antibody-receptor recombination targeting both CD47 and CD20, IMM0306, enters phase II clinical trial. The application of the fusion protein drug candidate IMM0306 combined with lenalidomide in the therapy of relapsed and refractory non-Hodgkin's lymphoma has been accepted by the National Medical Products Administration (NMPA). This is another milestone in the development of new drugs for ImmuneOnco.
Previously, IMM0306 has been approved by the Chinese NMPA and the U.S. FDA to carry out clinical trials, and has obtained patent authorizations in China, the U.S. and Japan, consolidating the company’s leading position in CD47-targeting drug development and bispecific antibody research.
Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, said:
"I am very glad to see that the clinical trial application of our IMM0306 project combined with lenalidomide in the treatment of relapsed and refractory non-Hodgkin's lymphoma has been accepted by the National Medical Products Administration (NMPA). IMM0306 is an antibody that targets both CD47 and CD20, a recombinant fusion protein (mAb-Trap), is the first CD47xCD20 bispecific molecule that entered the clinical trial stage. IMM0306 does not bind to human red blood cells, and its efficacy is significantly better than that of rituximab at the same dose. Preliminary data from Phase I demonstrated good safety and excellent clinical efficacy response, and it is expected to replace rituximab as the first-line treatment option for patients with B-cell lymphoma in the future."
"We will continue to further expand the clinical trial of the IMM0306 project to benefit more subjects. We are going to fasten our steps to launch IMM0306 to the market so as to benefit cancer patients as soon as possible."