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ImmueOnco’s IMM0306 combined with lenalidomide for the advanced relapsed/refractory follicular lymphoma (FL) completed the phase Ib dose escalation and officially entered phase II clinical trial

On March 11, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK) announced that the Phase Ib/II clinical study of the company developed bispecific antibody-receptor recombinant protein drug targeting both CD47 and CD20 (Project No.: IMM0306) in combination with lenalidomide (Study No.: IMM0306-003) for the treatment of advanced relapsed/refractory follicular lymphoma (FL) was discussed at the SRC meeting and the Phase II recommended dose was determined, So the project entered Phase II clinical trial officially. This is another milestone achievement in the rapid development of ImmuneOnco.

Previously, IMM0306 obtained permission from China's NMPA and the US FDA to conduct clinical trials, and obtained patent authorization in China, the United States, Japan and Europe, consolidating ImmuneOnco’s leading position in the research echelon of CD47 target drug development and bispecific antibodies. Recently, the Safety Review Committee (SRC) unanimously approved 1.6mg/kg QW as the RP2D dose of IMM0306 in combination with lenalidomide for the treatment of advanced relapsed/refractory follicular lymphoma (FL) to enter Phase II for further development. In the phase I clinical study in relapsed or refractory B-cell lymphoma, IMM0306 monotherapy showed encouraging efficacy and a favorable safety profile, with no DLTs observed in any of the eight dose groups. Five cases of CR and five cases of PR were observed in four dose groups, starting from 0.8 mg/kg to 2.0 mg/kg, and the ORR of relapsed and refractory FL reached 41%. At the same time, all patients did not have significant cytokine storm toxicity.

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

"We are very pleased to see that our IMM0306 in combination with lenalidomide in patients with advanced relapsed/refractory follicular lymphoma (FL) has determined the recommended Phase II dose. Data from the Phase I clinical study showed a favorable safety and clinical efficacy of monotherapy, especially in the combination escalation study of lenalidomide, in which 11 patients with FL/MZL who failed at least one prior line of therapy were enrolled, and ORR of 75% was observed (2 patients with CR and 4 patients with PR). We firmly believe that the development of second-line follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) will be extremely competitive in the market. We will continue to promote the research of IMM0306 projects and strive to bring good news to cancer patients as soon as possible. ”

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

   "Today, it is important for our company to determine the recommended dose in a Phase II clinical study of IMM0306, one of our main products, in combination with lenalidomide in patients with advanced relapsed/refractory follicular lymphoma (FL). At present, outstanding efficacy has been observed in multiple indications (including indolent lymphoma dominated by FL and MZL and DLBCL, the most common aggressive lymphoma in clinical practice), indicating that the product has broad clinical development prospects. IMM0306 Phase I data was postered at ASCO 2023 conference attracted the attention of many global researchers. At present, we have carried out a comprehensive layout of this product, not just a single-agent clinical development project, but also a combined LEN project to fully develop NHL indications, not only for FL, MZL, DLBCL and other indications. In the current combination escalation study with lenalidomide, in FL/MZL patients who have failed at least first-line therapy, 75% ORR was observed (2 CR patients, 4 PR patients), and the company will accelerate the clinical development of this product. We look forward to bringing new treatment options to cancer patients.”