ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced that the Phase II clinical trial of ImmuneOnco Biopharmaceuticals bispecific antibody-receptor recombinant protein drug (Project No. IMM0306), which targets both CD47 and CD20, was completed on 3rd April. This is another milestone achievement in the rapid development of ImmuneOnco Biopharmaceuticals.

Previously, IMM0306 had obtained clinical trial approvals from China NMPA and US FDA, as well as patent authorizations from China, US, and Japan, solidifying ImmuneOnco Biopharmaceuticals' leading position in the development of CD47 targeted drugs and bispecific antibodies research. On March 16th, following unanimous agreement from project research experts, IMM0306 selected a safe and effective single-agent dose of 2mg/kg to enter into the IIa phase of clinical trials, targeting further clinical development in indications for indolent lymphomas such as third-line and above follicular lymphoma (FL) and marginal zone lymphoma (MZL). At the same time, the Ib/IIa phase of clinical trials for IMM0306 in combination with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma (FL) is also underway.

The preliminary data from the Phase I clinical trial has demonstrated encouraging efficacy and favorable safety profile of IMM0306. IMM0306 was safe and well tolerated up to 2.0 mg/kg. Among the evaluable patients across four cohorts dosed from 0.8 mg/kg to 2.0 mg/kg, who had relapsed or progressed after receiving rituximab previously, three CRs and four PRs were observed. Also, no significant cytokine storm toxicity was observed in all patients.

Dr. Wenzhi Tian, founder and chairman of ImmuneOnco Biopharmaceuticals, said:

"We are very pleased to see the first subject enrolled in our Phase II clinical trial of IMM0306, a recombinant antibody-receptor protein (mAb-Trap) targeting both CD47 and CD20 and is the first CD47 and CD20 dual-targeting bispecific to enter into clinical stage globally. IMM0306 does not bind to human erythrocytes in vitro and has been shown to be significantly more effective than rituximab at the same dose in preclinical in vivo efficacy trials. data from phase I clinical studies have demonstrated a favorable safety and clinical efficacy response as a single agent, with encouraging tumor efficacy observed particularly in patients with relapsed refractory FL and MZL and DLBCL. We will continue to advance the IMM0306 program and strive to bring early benefits to the majority of cancer patients."

Dr. Qiying Lu, Chief Medical Officer/Senior Vice President of ImmuneOnco Biopharmaceuticals, stated:

"Today's completion of the first subject enrollment in the Phase II clinical trial of IMM0306, one of our core products, is of great significance to our company. The outstanding efficacy of the single drug has been observed in multiple indications (including inert lymphomas, mainly FL and MZL, and DLBCL, the most common aggressive lymphoma in clinical settings), demonstrating the broad clinical development potential of the product. We are currently in the process of developing a comprehensive product portfolio, including FL, MZL, DLBCL, and further clinical development in lymphoma indications such as WM (Wolbachia Macroglobulinemia), and will fully realize our differentiated portfolio. In addition to single agents, we have plans to further develop our product in combination with other standard treatments including lenalidomide in frontline lymphoma. The Company will accelerate the clinical development of this product in anticipation of bringing new options to oncology treatment and meeting the clinical needs of unmet patients.Previously, IMM0306 had obtained clinical trial approvals from China NMPA and US FDA, as well as patent authorizations from China, US, and Japan, solidifying ImmuneOnco Biopharmaceuticals' leading position in the development of CD47 targeted drugs and bispecific antibodies research. On March 16th, following unanimous agreement from project research experts, IMM0306 selected a safe and effective single-agent dose of 2mg/kg to enter into the IIa phase of clinical trials, targeting further clinical development in indications for indolent lymphomas such as third-line and above follicular lymphoma (FL) and marginal zone lymphoma (MZL). At the same time, the Ib/IIa phase of clinical trials for IMM0306 in combination with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma (FL) is also underway.

The preliminary data from the Phase I clinical trial has demonstrated encouraging efficacy and favorable safety profile of IMM0306. IMM0306 was safe and well tolerated up to 2.0 mg/kg. Among the evaluable patients across four cohorts dosed from 0.8 mg/kg to 2.0 mg/kg, who had relapsed or progressed after receiving rituximab previously, three CRs and four PRs were observed. Also, no significant cytokine storm toxicity was observed in all patients.

Dr. Wenzhi Tian, founder and chairman of ImmuneOnco Biopharmaceuticals, said:

"We are very pleased to see the first subject enrolled in our Phase II clinical trial of IMM0306, a recombinant antibody-receptor protein (mAb-Trap) targeting both CD47 and CD20 and is the first CD47 and CD20 dual-targeting bispecific to enter into clinical stage globally. IMM0306 does not bind to human erythrocytes in vitro and has been shown to be significantly more effective than rituximab at the same dose in preclinical in vivo efficacy trials. data from phase I clinical studies have demonstrated a favorable safety and clinical efficacy response as a single agent, with encouraging tumor efficacy observed particularly in patients with relapsed refractory FL and MZL and DLBCL. We will continue to advance the IMM0306 program and strive to bring early benefits to the majority of cancer patients."

Dr. Qiying Lu, Chief Medical Officer/Senior Vice President of ImmuneOnco Biopharmaceuticals, stated:

"Today's completion of the first subject enrollment in the Phase II clinical trial of IMM0306, one of our core products, is of great significance to our company. The outstanding efficacy of the single drug has been observed in multiple indications (including inert lymphomas, mainly FL and MZL, and DLBCL, the most common aggressive lymphoma in clinical settings), demonstrating the broad clinical development potential of the product. We are currently in the process of developing a comprehensive product portfolio, including FL, MZL, DLBCL, and further clinical development in lymphoma indications such as WM (Wolbachia Macroglobulinemia), and will fully realize our differentiated portfolio. In addition to single agents, we have plans to further develop our product in combination with other standard treatments including lenalidomide in frontline lymphoma. The Company will accelerate the clinical development of this product in anticipation of bringing new options to oncology treatment and meeting the clinical needs of unmet patients.