On March 17, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced that its self-developed bispecific antibody-receptor recombinant protein drug targeting both CD47 and CD20 (project number: IMM0306) completed phase I dose escalation study and officially entered phase IIa clinical trial for third-line and above advanced follicular lymphoma (FL). This is another milestone achievement for  ImmuneOnco in its rapid development.

Previously, IMM0306 has been approved by China's NMPA and the US FDA for clinical trials and has been granted patents in China, the US, and Japan, consolidating ImmuneOnco Biopharmaceuticals‘ leading position in the development of CD47-targeted drugs and bispecific antibody research. Currently, the IMM0306 project has been selected by project experts to enter the IIa phase clinical trial with a single safe and effective dose of 2mg, targeting FL and marginal zone lymphoma (MZL) and other indolent lymphomas of third-line and above. Meanwhile, the Ib/IIa phase clinical trial of IMM0306 in combination with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma is also underway.

The phase I clinical study of IMM0306 targeting relapsed or refractory B-cell lymphoma showed encouraging efficacy and good safety characteristics. From four different dose groups ranging from 0.8mg/kg to 2.0mg/kg, two cases of complete response and five cases of partial response have been observed, and it is encouraging that no significant cytokine storm toxicity has been observed in all patients.

Founder and Chairman of ImmuneOnco Biopharmaceuticals

Dr. Wenzhi Tian stated:

“I am thrilled to announce that our IMM0306 project has completed Phase I study and entered Phase IIa clinical trial for the treatment of relapsed/refractory follicular lymphoma (FL) of third line and beyond. IMM0306 is a first-in-class CD47xCD20 bispecific antibody-receptor fusion protein (mAb-Trap) targeting both CD47 and CD20, and is the first CD47xCD20 dual-targeting molecule entering clinical development globally. In vitro, IMM0306 does not bind to human red blood cells, and preclinical pharmacology studies showed that its efficacy at the equivalent dose was significantly better than rituximab. Phase I clinical data demonstrated good safety profile and promising clinical efficacy as a monotherapy, particularly in patients with relapsed/refractory FL, marginal zone lymphoma (MZL), and DLBCL. We will continue to advance the research of the IMM0306 project and aim to bring a new hope to cancer patients as soon as possible.”

Chief Medical Officer/Senior Vice President of ImmuneOnco Biopharmaceuticals

Dr. Qiying Lu stated:

“Today, for our company, it is of great significance that IMM0306, one of our core products, has completed phase I dose escalation and smoothly entered phase IIa. Currently, outstanding efficacy has been observed in monotherapy for multiple indications, including indolent lymphomas such as FL and MZL, as well as the most common aggressive lymphoma in the clinic, DLBCL, indicating the broad clinical development prospects of this product. We have comprehensively planned the development of this product in multiple indications, which will fully reflect our differentiated layout. Not only in monotherapy, but we also plan to further develop it in combination with other standard treatments, including lenalidomide, for frontline lymphoma. The company will accelerate the clinical development of this product and look forward to bringing new choices for cancer treatment and meeting the clinical needs of unmet patients.”