WALTHAM, Mass. — Palleon Pharmaceuticals has announced that the first patient has been dosed in a Phase 2 clinical trial of its investigational therapy E-602 (HLX79), marking a major milestone in the company’s push to apply its glyco-immunology platform to autoimmune diseases.
The study is evaluating E-602 in combination with HANLIKANG, a rituximab biosimilar developed by Chinese biopharmaceutical company Henlius, in patients with active glomerulonephritis, a group of autoimmune kidney conditions that includes membranous nephropathy (MN) and lupus nephritis (LN). The trial is being conducted at multiple centers across mainland China.
This is the most advanced clinical trial of E-602 to date, and the first time Palleon’s glyco-immunology approach is being tested in autoimmune indications, following earlier development work in cancer.
“E-602’s unique dual mechanism enhances depletion of autoreactive memory B cells and reduces pro-fibrotic macrophages that cause organ damage,” said Dr. Jim Broderick, CEO and Founder of Palleon Pharmaceuticals. “We believe glyco-immunology can change the treatment paradigm in autoimmune diseases by enabling the targeting of pathogenic immune cells.”
Glomerulonephritis occurs when the immune system mistakenly attacks healthy kidney tissues, leading to inflammation and potential long-term damage. MN, which is more prevalent in East Asia and Europe, is a leading cause of nephrotic syndrome and results in severe kidney-related complications. LN is a manifestation of systemic lupus erythematosus that also results in kidney damage.
E-602 is a human sialidase enzyme therapy designed to degrade sialoglycans, sugar molecules that allow harmful immune cells to evade detection. By targeting these molecules, E-602 enhances immune clearance of autoreactive memory B cells and M2-like macrophages, both key contributors to inflammation and fibrosis in autoimmune diseases.
Earlier studies combining E-602 with rituximab demonstrated enhanced depletion of pathogenic B cells without triggering severe immune reactions like cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), which are risks associated with some B-cell targeting therapies such as CAR T and bispecific T cell engagers.
E-602 showed a favorable safety profile in a completed Phase 1 trial, with no dose-limiting toxicities, supporting its potential as a community-friendly treatment option.
The current Phase 2 trial is a double-blind, randomized, placebo-controlled, multicenter study focused on evaluating the efficacy, safety, and tolerability of the E-602 and HANLIKANG combination in glomerulonephritis patients.
This trial builds on a strategic agreement between Palleon and Henlius, first announced in December 2024, to co-develop glyco-immunology-based treatments for autoimmune diseases.
