Kidney Week

Abstract: FR-PO0840

Rapid Clinical Responses in a Phase 2 Trial of HLX79 (E-602), a First-in-Class Human Sialidase-Fc Fusion Protein, Plus HLX01 (Biosimilar Rituximab) in Membranous Nephropathy

Session Information

• Glomerular Diseases: Practice and New Concepts Shaping Modern Care
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Li, Zhilian, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Zhilian Li, MD, PhD

• Yu, Xueqing, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Xueqing Yu, MD, PhD

• Fan, Qiuling, Shanghai General Hospital, Shanghai, China

Qiuling Fan, MD

• Zuo, Li, Peking University People's Hospital, Beijing, China

Li Zuo, MD, PhD

• Wang, Deguang, The Second Hospital of Anhui Medical University, Hefei, China

Deguang Wang, MD

• Lv, Rong, The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China

Rong Lv, PhD

• Wang, Junxia, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China

Junxia Wang

• Ye, Zhiming, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Zhiming Ye

• Xu, Hui, Xiangya Hospital of Central South University, Changsha, China

Hui Xu, DrMed, DrPH

• Shao, Leping Shao,, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

Leping Shao, Shao

• Yan, Yan, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

Yan Yan, MD

• Mao, Huijuan, Jiangsu Province Hospital, Nanjing, China

Huijuan Mao, MD, PhD

• Zhong, Aimin, Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China

Aimin Zhong, MBBS

• Chen, Cheng, Wuhan University Renmin Hospital, Wuhan, Hubei, China

Cheng Chen, MD, PhD

• Lu, Wanhong, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China

Wanhong Lu, MD

• Cao, Lizhi, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States

Lizhi Cao, PhD

• Brenner, Louis, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States

Louis Brenner, MD

• Peng, Li, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States

Li Peng, PhD

• Broderick, James W., Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States

James W. Broderick, MD

• Zang, Yunna, Shanghai Henlius Biotech Inc, Shanghai, China

Yunna Zang, PharmD

• Wang, Yating, Shanghai Henlius Biotech Inc, Shanghai, China

Yating Wang, MD

• Han, Lin, Shanghai Henlius Biotech Inc, Shanghai, China

Lin Han

Background

Primary membranous nephropathy (pMN) is the most common cause of autoimmune nephrotic syndrome in adults, with 40% of patients (pts) progressing to fibrosis or kidney failure. Rituximab (RTX) is the standard of care (SoC) for pMN, but responses are slow (approximately 60% PR/CR rate at 24 months) and high-risk pts have poorer responses. HLX79 is a first-in-class human sialidase-Fc fusion protein that enzymatically removes cell-surface sialoglycans, modulating immune cell regulation.

Methods

This double-blind, placebo-controlled Ph2 trial (NCT07038382) randomized pMN pts 3:1 (HLX79 + HLX01 [RTX biosimilar] versus HLX01) across three dose cohorts: C1 (10 mg/kg, n=8), C2 (20 mg/kg, n=9), and C3 (30 mg/kg, n=9). All pts received HLX79 or placebo (4 weekly doses) plus HLX01 375 mg/m² weekly. Primary endpoints were safety and tolerability. Secondary endpoints included CR/PR rates (KDIGO 2021) and change in proteinuria. Exploratory biomarkers were PLA2R Abs, urine sCD163, and blood B cell subsets.

Results

Baseline characteristics were comparable across cohorts and consistent with the MENTOR trial. Overall, 54% (14/26) of pts achieved PR within 12–24 weeks, compared with approximately 20% of pts achieved PR at 12 weeks in the RTX arm of the MENTOR trial.
C1 (10 mg/kg): 7 evaluable pts, 1 PR at 12 weeks, 3 PRs at 24 weeks;
C2 (20 mg/kg): 9 evaluable pts, 4 PRs at 12 weeks;
C3 (30 mg/kg): 9 evaluable pts, 7 PRs at 12 weeks.
Among high-dose pts (C2+C3), 5 PRs were achieved in the high-risk subset (n=10).
TEAEs were predominantly Grade 1–2. No HLX79-related Grade ≥3 events were observed; one Grade 3 SAE was assessed as unrelated to either study drug.

Conclusion

Blinded interim Ph2 data in pMN demonstrate early, rapid, and deep proteinuria reductions with HLX79 (20 and 30 mg/kg) + RTX, exceeding historical RTX responses. The combination was well-tolerated. The data suggest potential improvements in speed and depth of responses with the addition of HLX79 to RTX SoC. Fully unblinded data including biomarker analyses will be presented at the conference.

Change from baseline in 24-hour urine protein and serum albumin at Week 12

Funding

• Commercial Support – This study was supported by Shanghai Henlius Biotech, Inc.