On April 22, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco"), HKEX stock code: 01541.HK) announced that the Phase Ib clinical trial of IMM0306 in combination with lenalidomide for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) completed the first patient enrollment, marking another milestone in the company's rapid development.

IMM0306 is a global first CD47xCD20 bi-specific molecule to enter the clinical trial stage. The company carries out a comprehensive layout of this product to explore multiple indications. Recently, two clinical research results of IMM0306 were selected for the 2024 American Society of Clinical Oncology (ASCO) annual meeting. IMM0306 for the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) Phase I preliminary study results will be presented in the form of abstract; Another Phase Ib clinical study of IMM0306 combined with lenalidomide for the treatment of relapsed/refractory follicular lymphoma (FL) and marginal band lymphoma (MZL) was published online.

At present, In IMM0306 monotherapy appeared to have outstanding efficacy in multiple indications (including the inert lymphoma dominated by FL and MZL and DLBCL, the most common aggressive lymphoma in clinical practice). In a Phase I clinical study for relapsed or refractory B-cell lymphoma, IMM0306 monotherapy showed encouraging efficacy and a good safety profile, with no DLT observed in any of the eight dose groups and cytokine storm toxicity was not reported in all patients. In higher four dose groups (ranging from 0.8mg/kg to 2.0mg/kg), 5 cases of CR and 5 cases of PR were observed, and the ORR for treatment of relapsed refractory FL reached 41%.

In June 2023, the Phase Ib/IIa clinical trial of IMM0306 combined with lenalidomide in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) completed the first enrollment of subjects. In March this year, after discussion by the Safety Review Committee (SRC), it was unanimously approved that 1.6mg /kg QW as the RP2D dose of IMM0306 combined with lenalidomide for the treatment of advanced relapsed/refractory follicular lymphoma (FL). In addition, IMM0306 obtained patent authorization in China, the United States, Japan and Europe, consolidating leading position of ImmuneOnco in CD47/SIRPa-related drug development.

Dr. Tian Wenzhi, founder and Chairman of ImmuneOnco, said:

"We are very pleased to have the first enrollment of our Phase Ib clinical trial of IMM0306 in combination with lenalidomide in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Phase I clinical study data showed good safety and clinical efficacy in monotherapy and combination with lenalidomide. In the enrolled 11 FL/MZL patients with at least 1 line of prior treatment failure, ORR reached 81.8% (3 CR, 6 PR patients). We firmly believe that IMM0306 has significant market competitiveness in late-line follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). We will continue to promote the research of IMM0306 project and strive to bring benefits to cancer patients as soon as possible."

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

"It is of great significance for our company today to complete the first enrollment of the Phase Ib clinical trial of IMM0306, one of our key products, in combination with lenalidomide in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). At present, the outstanding efficacy of monotherapy has been observed in multiple indications (including the inert lymphoma dominated by FL and MZL and the most common aggressive lymphoma in clinical practice DLBCL), the data indicates that IMM0306 has broad clinical development prospects. This year, IMM0306 also had two clinical innovation research results selected for the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. At present, we are carrying out a comprehensive layout. In the current lenalidomide-combined escalation study, ORR reaches 81.8% (3 CR, 6 PR patients) in FL/MZL patients who failed at least first-line treatment. The company will accelerate the clinical development of this product for R/R DLBCL indications. We look forward to bringing new treatment options to patients with unmet medical need for R/R DLBCL."