Company News

ImmuneOnco to Present Latest Phase Ib/II Clinical Results of IMM0306 in Systemic Lupus Erythematosus at ACR 2026
2026-10-10
40

Shanghai, China, October 10, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco”) announced today that it will present the latest Phase Ib/II clinical results of amulirafusp alfa (IMM0306/IMC-002), an internally developed investigational therapy for systemic lupus erythematosus (SLE), in a poster presentation at the 2026 American College of Rheumatology Annual Meeting (ACR 2026), to be held in Orlando, Florida, USA, from November 6 to 11, 2026.


ACR 2026 Poster Details for Amulirafusp Alfa (IMM0306):

Title: IMC-002 (IMM0306), a bispecific CD20×CD47 fusion protein, demonstrates improvements in active Systemic Lupus Erythematosus patients in a phase Ib/II study
Submission Number: 2456255
Session: Poster Session C, (2192-2227) Systemic Lupus Erythematosus - Treatment Poster C
Date: Tuesday November 10, 2026
Presentation Time: 10:30 AM - 12:30 PM


Amulirafusp alfa (amulirafusp alfa, IMM0306/IMC-002) is a novel myeloid cell engager (MCE) developed on ImmuneOnco’s mAb-Trap platform that simultaneously targets CD47 and CD20. The molecule is now in clinical development for SLE. In August 2026, the U.S. Food and Drug Administration (FDA) approved the investigational new drug (IND) application for IMM0306 in SLE, marking a key step in the global clinical development of IMM0306 for autoimmune diseases.


In oncology, a Phase III study of IMM0306 in combination with lenalidomide is ongoing. Latest Phase Ib/IIa clinical data have shown high response rates, durable progression-free survival benefit, and favorable safety in patients with relapsed/refractory marginal zone lymphoma (R/R MZL) and relapsed/refractory follicular lymphoma (R/R FL). The R/R MZL cohort achieved an objective response rate (ORR) of 92.3% and a complete response rate (CRR) of 53.8%, while the R/R FL cohort achieved an ORR of 88.6% and a CRR of 70.5%, with no cytokine release syndrome (CRS)-related toxicity observed. These positive findings provide strong support for the expansion of IMM0306 into B-cell-mediated autoimmune diseases.


Beyond SLE, ImmuneOnco continues to expand its autoimmune pipeline, with clinical studies of IMM0306 in IgG4-related disease and primary membranous nephropathy progressing steadily. Leveraging the high response potential and low CRS risk associated with its MCE mechanism, IMM0306 has the potential to offer a highly promising and differentiated treatment option for patients with B-cell-mediated cancers and autoimmune diseases.


Dr. Wenzhi Tian, Chairman, Chief Executive Officer and Chief Scientific Officer of ImmuneOnco, commented:

“Amulirafusp alfa (IMM0306) is the first macrophage-based MCE therapeutic molecule designed and developed by our company. Because macrophages are predominantly distributed in tissue organs, activating macrophages is expected to clear pathogenic B lymphocytes within diseased tissues and thereby achieve durable therapeutic effects. Early clinical results in lymphoma and systemic lupus erythematosus have already shown encouraging signs of clinical activity, and the latest Phase Ib/II results to be presented at next month’s ACR Annual Meeting are particularly anticipated. We will continue to advance the Phase II/III clinical development of this program, with the goal of providing better and safer treatment options for patients with moderate-to-severe systemic lupus erythematosus.”


Dr. Zhuli Wu, Chief Medical Officer of ImmuneOnco, stated:

“IMM0306 is an innovative bispecific fusion protein targeting CD47 and CD20 that can precisely target pathogenic B cells through a dual mechanism of action, enabling efficient inhibition and clearance of diseased cells. Data previously presented at the 2026 EULAR Congress demonstrated that IMM0306 can achieve deep B-cell depletion while maintaining a favorable safety profile. The latest Phase Ib/II clinical results to be presented at ACR 2026 will further highlight the clinical data and therapeutic potential of IMM0306 in patients with active systemic lupus erythematosus. Going forward, we will continue to steadily advance the clinical development of IMM0306, maintain rigorous oversight of development quality and safety, and accelerate the clinical translation of this innovative therapy to bring new treatment options to patients with SLE worldwide.”