On December 6, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as “ImmuneOnco,” with the stock code 01541.HK on the Hong Kong Stock Exchange) announced that the full text of the Phase I clinical trial data of Amulirafusp Alfa (IMM0306) for lymphoma, titled “Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study,” has been accepted for publication by the Journal of Hematology & Oncology.

Amulirafusp Alfa (IMM0306) is the first CD47xCD20 bispecific molecule to enter the clinical trial stage globally. ImmuneOnco has comprehensively developed this product. Currently, IMM0306 monotherapy has shown positive efficacy across multiple subtypes of refractory or relapsed CD20-positive B-cell non-Hodgkin lymphoma, including indolent lymphomas such as follicular lymphoma (FL) and marginal zone lymphoma (MZL), as well as the most common aggressive lymphoma, diffuse large B-cell lymphoma (DLBCL). In the Phase I clinical study for refractory or relapsed CD20-positive B-cell non-Hodgkin lymphoma, IMM0306 monotherapy demonstrated encouraging efficacy and good safety characteristics, with no dose-limiting toxicities (DLTs) observed across eight dose cohorts.

In June 2023, the Phase Ib/IIa clinical trial of IMM0306 in combination with lenalidomide for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma completed the first patient enrollment and dosing. In March of this year, after discussion by the Safety Monitoring Committee (SMC), IMM0306 in combination with lenalidomide advanced to Phase IIa development for relapsed/refractory follicular lymphoma (FL) following at least one line of standard therapy.

As of the end of October 2024, in the Phase Ib/IIa clinical trial of Amulirafusp Alfa (IMM0306) in combination with lenalidomide for indolent lymphoma, a total of 27 patients were evaluable for efficacy (25 with FL and 2 with MZL). As assessed by the investigators: among the 25 evaluable patients with relapsed/refractory (R/R) FL, the overall response rate (ORR) and complete response rate (CRR) were 84.0% and 40.0%, respectively; additionally, the ORR was 100% in the 2 evaluable patients with R/R MZL. These results demonstrated a significant efficacy signal, and the study is actively enrolling and observing patients.

Statement from ImmuneOnco’s Founder and Chairman

Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, stated:

“We are honored that the Journal of Hematology & Oncology, an internationally renowned academic journal, has accepted the full text of the Phase I clinical trial data of Amulirafusp Alfa (IMM0306) for lymphoma. These data not only confirm the potential and efficacy of IMM0306 in treating relapsed/refractory B-cell non-Hodgkin lymphoma but also reflect ImmuneOnco’s determination and strength in innovative drug research and development. The Phase I and II clinical data obtained so far have confirmed the safety and efficacy of IMM0306 and have shown its potential as a monotherapy or in combination with other targeted immune checkpoint inhibitors. We will continue to be committed to advancing the subsequent studies of IMM0306, with the hope of bringing more treatment options and hope to lymphoma patients worldwide and delivering good news to cancer patients at the earliest possible time.”