Palleon Pharmaceuticals Presents Phase 2 Results for HLX79/E-602 in Primary Membranous Nephropathy at ASN Kidney Week 2026
HLX79/E-602 plus rituximab produced faster responses and a higher response rate than rituximab alone, with a safety profile suited to outpatient administration
WATERTOWN, Mass., October 23, 2026--Palleon Pharmaceuticals, a clinical-stage biotechnology company developing glycan editing therapeutics for autoimmune disease and cancer, today announced Phase 2 results for HLX79/E-602 (efgitasialase alfa), a first-in-class sialidase-Fc fusion protein, in primary membranous nephropathy (pMN).
The data were presented today in a late-breaking oral session at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver.
The randomized Phase 2 trial (NCT07038382) was conducted in China by Palleon's partner Shanghai Henlius Biotech (2696.HK) and enrolled 26 patients with pMN. Patients received rituximab biosimilar (Henlius' HANLIKANG) alone or with HLX79/E-602 at 10, 20 or 30 mg/kg. Dosing was weekly for four weeks, with re-dosing at six months.
Results at 30 mg/kg of HLX79/E-602 plus rituximab versus rituximab alone:
Faster response: Median time to first clinical response was 3 weeks, versus 11 weeks for rituximab alone.
Higher response rate: At week 36, 100% of patients (7 of 7) were in complete or partial remission, including 3 complete remissions. With rituximab alone, 50% of patients (3 of 6) had responded. At week 24, before re-dosing, the rates were 86% (6 of 7) for the combination and 67% (4 of 6) for rituximab alone.
Safety: HLX79/E-602 was well-tolerated at all doses. No severe adverse events were attributed to HLX79/E-602.
"In membranous nephropathy, the immune system attacks the kidneys, and the longer the disease stays active, the greater the risk of permanent kidney damage," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon Pharmaceuticals. "Adding HLX79/E-602 to rituximab produced responses in weeks rather than months, helped more patients to respond, and was well-tolerated in an outpatient setting. We believe glycan editing could offer a new way to treat autoimmune disease."
Primary membranous nephropathy is an autoimmune disease in which the immune system damages the kidneys. It is one of the most common causes of severe protein loss through the kidneys in adults and can lead to kidney failure. Rituximab is recommended by clinical guidelines, but complete or partial remission usually takes months, and only about half of patients ultimately respond. HLX79/E-602 enzymatically removes sialic acid, a sugar found on cell surfaces that helps disease-driving immune cells, including macrophages, to persist in inflamed tissue.