• IMM0306 has demonstrated a strong efficacy signal in the preliminary data for SLE, with efficient and sustained B-cell depletion and immune reconstitution. It has shown rapid and dose-dependent improvement in SLEDAI-2K scores.

• The safety profile of IMM0306 in SLE is favorable, with no grade 3 or above anemia and no cytokine storm of any grade observed.

• The clinical trial of IMM0306 for SLE is ongoing, with the efficacy assessment of all dose groups in Phase Ib expected to be completed in the first quarter of next year.

On June 25, 2025, in Shanghai, China, Immuneonco Biomedical Technology (Shanghai) Co., Ltd. (referred to as "Immuneonco," with the stock code 01541.HK on the Hong Kong Stock Exchange) announced that the Phase Ib clinical trial of its independently developed IMM0306 for the treatment of SLE had made significant progress. The efficacy in the 1.2 mg/kg dose group was particularly outstanding, and the safety data of both dose groups were very satisfactory. The relevant data has been presented at the recent BIO conference in Boston and has attracted high attention and positive feedback from the attending experts.

Key Data of Phase Ib Clinical Trial of IMM0306 for SLE

The proportion of patients with a reduction of ≥4 points in SLEDAI-2K score from baseline

Note: Patients included in the efficacy analysis had completed ≥4 doses and at least one efficacy evaluation (with 7 patients in the 0.8 mg/kg cohort and 6 patients in the 1.2 mg/kg cohort).

• Efficacy of the first dose group (0.8 mg/kg):

  • Among the 7 subjects, 4 had a reduction of ≥4 points in SLEDAI-2K score from baseline (57.1%), indicating improvement in disease activity.

  • One subject's SLEDAI-2K score was reduced to 0.

  • The PGA score of all 7 subjects showed no worsening (100%).

• Significant efficacy of the second dose group (1.2 mg/kg):

  • Among the 6 subjects, 5 had a reduction of ≥4 points in SLEDAI-2K score from baseline (83.3%), indicating significant improvement in disease activity.

  • One subject's SLEDAI-2K score was reduced to 0.

  • The PGA score of all 6 subjects showed no worsening (100%).

• Good safety of both dose groups:

  • Both dose groups demonstrated good tolerability.

  • One subject in each of the 0.8 mg/kg and 1.2 mg/kg dose groups experienced ≥Grade 3 adverse events, both of which were transient thrombocytopenia, and both recovered spontaneously within 4-5 days without intervention.

  • No cytokine storm of any grade was observed.

Data as of June 6, 2025

Phase II Clinical Data of IMM0306 in Relapsed/Refractory Follicular Lymphoma

• In 34 patients treated in combination with lenalidomide, the CRR was 64.7%, the ORR was 88.2%, and the DCR was 94.1%.

Data as of June 9, 2025

At the recent BIO conference, Immuneonco presented the updated clinical data of IMM0306 mentioned above, which has attracted widespread attention from the attending experts. The experts highly recognized the remarkable efficacy and excellent safety of IMM0306 in the treatment of SLE.

The updated clinical safety and efficacy data of IMM0306 have been more elaborately explained in the latest corporate presentation published on Immuneonco's investor relations webpage, which can be accessed at the following link: https://www.immuneonco.com/investor/promote/index.html#JInformation

Dr. Tian Wenzhi, founder, chairman, CEO, and CSO of Immuneonco, stated:

"We have made exciting progress in the clinical trial of IMM0306 for the treatment of SLE. IMM0306 is a fusion protein of CD20 mAb, with the CD47 binding domain of SIRPα on both heavy chains. Compared with rituximab, IMM0306 has stronger ADCC/ADCP activity. In vitro experiments have shown that it does not bind to human red blood cells and has a higher affinity for CD20, better avoiding the killing of normal cells. The preliminary data indicate that IMM0306 has shown good efficacy and safety in different dose groups, which further confirms its great potential as a CD47xCD20 bispecific antibody in the treatment of autoimmune diseases."