Company News

ImmuneOnco Initiates Phase III Trial of Amouravfop Alfa (IMM0306) in Relapsed/Refractory Follicular Lymphoma
2026-03-30
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Shanghai, China, March 30, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco"; HKEX Stock Code: 01541.HK) today announced that the Phase III clinical trial of its in-house developed bispecific antibody-receptor fusion protein, amourofavfop alfa (IMM0306), which simultaneously targets CD47 and CD20, has successfully completed the first patient dosing (FPI). This pivotal trial, evaluating amourofavfop alfa in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma (R/R FL), marks the official entry of the therapy into the pivotal clinical stage.


About Amouravfop alfa (IMM0306) in Combination with Lenalidomide

Amouravfop alfa (CD47xCD20, IMM0306) is the world's first CD47xCD20 dual-targeting specific molecule to enter clinical development, developed based on ImmuneOnco's proprietary "mAb-Trap" technology platform. ImmuneOnco has established a comprehensive strategic layout for this product. In early clinical studies, IMM0306 has demonstrated favorable safety profiles and significant clinical efficacy, showing the potential to transform the therapeutic landscape for relapsed/refractory follicular lymphoma (R/R FL).


Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated, "The successful enrollment of the first patient in the Phase III clinical trial of IMM0306 represents another significant milestone in ImmuneOnco's development. Our efficient execution, from receiving CDE approval to today's successful launch, reflects the team's firm conviction in innovative drug R&D. We are acutely aware of our responsibility, as follicular lymphoma patients have long been plagued by the challenge of relapse. With its unique dual-targeting mechanism, IMM0306 has demonstrated 'Best-in-Class' potential in early studies. We are fully committed to advancing this pivotal registration clinical study and look forward to validating its clinical value with high-quality data as soon as possible, providing a more effective and safer therapeutic option for lymphoma patients in China and globally."


Ms. Wu Zhuli, Chief Medical Officer of ImmuneOnco, commented, "The successful dosing of the first patient signifies the official commencement of the Phase III confirmatory journey for IMM0306. Based on the excellent efficacy and superior safety observed in the Phase II study of IMM0306, particularly the depth of response demonstrated in the CD20 antibody-refractory patient population, we are confident in the success of this Phase III trial. Our clinical team will rigorously and scientifically advance all clinical operations to accelerate the new drug's approval process and benefit a broad range of patients."