ImmuneOnco Biopharmaceuticals (Shanghai) Inc. has achieved a significant milestone with the completion of first patient enrollment in the Phase II clinical trial of IMM0306, marking a major advancement for the world's first CD47xCD20 bispecific molecule to enter clinical development. The company announced on April 3rd that IMM0306 has progressed to Phase IIa trials targeting third-line and above follicular lymphoma (FL) and marginal zone lymphoma (MZL) at a selected dose of 2mg/kg.
Clinical Efficacy Demonstrates Strong Therapeutic Potential
Phase I clinical data has revealed encouraging efficacy across multiple B-cell lymphoma indications. In the monotherapy study for relapsed or refractory B-cell lymphoma, IMM0306 demonstrated notable activity with 5 cases of complete response (CR) and 5 cases of partial response (PR) observed in the higher four dose groups ranging from 0.8mg/kg to 2.0mg/kg. The overall response rate (ORR) for treatment of relapsed refractory FL reached 41%.
The combination therapy results proved even more impressive. In the Phase Ib study combining IMM0306 with lenalidomide, 11 FL/MZL patients with at least one line of prior treatment failure achieved an ORR of 81.8%, with 3 complete responses and 6 partial responses. This combination approach has been approved to advance with 1.6mg/kg weekly as the recommended Phase 2 dose (RP2D) following unanimous approval from the Safety Review Committee.
Safety Profile Supports Continued Development
IMM0306 has demonstrated a favorable safety profile across all tested dose levels. No dose-limiting toxicities (DLT) were observed in any of the eight dose groups, and importantly, no cytokine storm toxicity was reported in all patients. The drug was safe and well tolerated up to 2.0 mg/kg, providing confidence for continued clinical development.
The bispecific molecule's design offers a key advantage in that it does not bind to human erythrocytes in vitro, potentially reducing the risk of anemia commonly associated with CD47-targeting therapies. Preclinical studies showed IMM0306 to be significantly more effective than rituximab at equivalent doses.
Comprehensive Clinical Development Strategy
ImmuneOnco is pursuing a comprehensive development strategy for IMM0306 across multiple lymphoma indications. The company is currently conducting Phase Ib/IIa clinical trials of IMM0306 combined with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma. Additionally, a Phase Ib clinical trial combining IMM0306 with lenalidomide for relapsed/refractory DLBCL completed first patient enrollment in April 2024.
The company's clinical research has gained recognition at major medical conferences, with two IMM0306 studies selected for presentation at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. One study focuses on relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, while another examines the combination therapy in FL and MZL patients.
Regulatory and Intellectual Property Position
IMM0306 has secured clinical trial approvals from both China's NMPA and the US FDA, enabling global development. The company has also obtained patent authorizations in China, the United States, Japan, and Europe, consolidating ImmuneOnco's leading position in CD47/SIRPα-related drug development and bispecific antibody research.
Dr. Tian Wenzhi, founder and Chairman of ImmuneOnco, emphasized the significance of these developments: "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 and Senior Vice President, highlighted the broad clinical potential: "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."
