April 26, 2026 – A National Investigators' Meeting for the "Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study of IMM0306 for Injection (Amulirafusp Alfa) in Combination with Lenalidomide versus Placebo in Combination with Lenalidomide in Subjects with Relapsed/Refractory Follicular Lymphoma," sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco"), was successfully held in Harbin.

The meeting brought together dozens of authoritative experts from leading centers nationwide, including Professor Song Yuqin from Peking University Cancer Hospital. The primary objectives were to provide an in-depth interpretation of the Phase III clinical study protocol for Amulirafusp Alfa (IMM0306) in relapsed/refractory follicular lymphoma (R/R FL), standardize clinical trial procedures, and ensure the high-quality advancement of this pivotal study.

Pivotal Phase III Study Officially Underway

Employing an internationally recognized randomized, double-blind, placebo-controlled design, the study aims to evaluate the efficacy and safety of the IMM0306 plus lenalidomide regimen compared to placebo plus lenalidomide for the treatment of R/R FL.

Notably, this program successfully completed the First Patient In (FPI) in March 2026, formally entering its pivotal clinical phase. The convening of this investigators' meeting signifies that the study is poised to enter an accelerated patient enrollment period.

Data-Driven: Phase I/II Studies Demonstrate "High Efficacy and Safety" Advantages

The meeting featured a retrospective review of the Phase I/II clinical data for IMM0306, which was presented at the 2025 American Society of Hematology (ASH) Annual Meeting. The data revealed impressive results for the IMM0306 plus lenalidomide regimen in patients with R/R FL:

Exceptional Efficacy: The objective response rate (ORR) reached 91.2%, and the complete response (CR) rate was 67.6%.

Safety Breakthrough: In a rare achievement for a CD47-targeted agent, no Cytokine Release Syndrome (CRS) was observed, and there were no treatment-related deaths. The overall safety profile was manageable.

These findings provide a solid foundation for the currently ongoing Phase III clinical study.

Expert Leadership Forging the Cornerstone of Research

The meeting commenced with opening remarks from Dr. Tian Wenzhi, Chairman, CEO, and CSO of ImmuneOnco, representing the sponsor, followed by an address from the meeting chair, Professor Song Yuqin.

In-depth Analysis to Define the Research Path

In the subsequent academic sessions, the ImmuneOnco team presented a detailed overview of the Phase III clinical study protocol for IMM0306 in R/R FL, focusing on the study objectives, inclusion/exclusion criteria, and efficacy endpoints (Complete Response Rate [CRR] and Progression-Free Survival [PFS]).

The meeting also featured special presentations from Feng Baokun, Medical Director at Guangzhou SinoImage, on central imaging assessment, and Wang Bianzhen from Junke Zhengyuan on the requirements for the central laboratory. Through these specialized sessions, investigators from all centers reached a strong consensus on trial operational procedures, imaging interpretation standards, and laboratory testing protocols.

The meeting concluded with summary remarks from Professor Song Yuqin and Dr. Tian Wenzhi. They once again expressed their gratitude for the support and dedication of all investigators and extended their best wishes for the smooth progress of the Phase III clinical study of IMM0306 in R/R FL, hoping for breakthrough results that will benefit a wide range of patients at the earliest opportunity.