Palleon Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of E-602 (HLX79), a Potential First-In-Class Treatment for Active Glomerulonephritis

• Clinical trial is evaluating Palleon’s E-602 (HLX79) in combination with Henlius’ HANLIKANG (biosimilar rituximab) for patients with active glomerulonephritis
• Phase 2 study is the first clinical trial of Palleon’s glyco-immunology platform in autoimmune diseases, and the most advanced trial of E-602 (HLX79) to date

WALTHAM, Mass.--(BUSINESS WIRE)--Palleon Pharmaceuticals, a company pioneering glyco-immunology drug development to treat autoimmune diseases and cancer, today announced the first patient has been dosed in the Phase 2 clinical trial of Palleon’s potential first-in-class human sialidase enzyme therapeutic E-602 (HLX79) in combination with Henlius’ self-developed HANLIKANG (rituximab biosimilar) in patients with active glomerulonephritis, a form of autoimmune kidney disease that includes membranous nephropathy (MN) and lupus nephritis (LN). The Phase 2 clinical trial is being conducted in mainland China.

“E-602’s unique dual mechanism enhances depletion of autoreactive memory B cells and reduces pro-fibrotic macrophages that cause organ damage. Preclinical and early clinical experiments of E-602 in combination with rituximab suggest that targeting these two key drivers of autoimmune pathologies can reduce the severity of autoimmune flares and improve treatment response in active glomerulonephritis,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “We believe glyco-immunology can change the treatment paradigm in autoimmune diseases by enabling the targeting of pathogenic immune cells. We look forward to working with Henlius to advance E-602 in this area of significant unmet need.”

Active glomerulonephritis comprises multiple forms of autoimmune kidney diseases, including MN and LN, which occur when the body’s immune system mistakenly attacks its own healthy tissues. MN is a leading cause of nephrotic syndrome, a collection of symptoms caused by kidney damage that leads to low blood albumin levels, high blood lipids, and significant swelling, and is more common in East Asia and Europe. LN similarly affects the kidney, leading to kidney damage in patients with systemic lupus symptoms. E-602 (HLX79) degrades sialoglycans, enhancing the clearance of two highly pathogenic immune cell populations in autoimmunity: autoreactive memory B cells, which drive inflammation, and M2-like macrophages which promote fibrosis and organ damage. Preclinical and early clinical experiments of E-602 (HLX79), in combination with rituximab, demonstrated enhanced depletion of pathogenic B cells versus rituximab alone, without the risk of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS). These syndromes have been associated with CAR T and T cell engager therapies for the elimination of B cells. E-602 (HLX79) demonstrated a favorable safety profile with no dose-limiting toxicities in a completed Phase 1 clinical trial, offering an attractive therapeutic profile for patients treated in community settings.

The Phase 2 clinical trial is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of E-602 (HLX79) in combination with HANLIKANG (rituximab biosimilar) in patients with active glomerulonephritis. The trial follows an agreement announced in December 2024 between Palleon and Henlius to advance glyco-immunology as a treatment for autoimmune diseases, building on the ongoing collaboration between the two companies.

For more information on this clinical trial, please visit: https://clinicaltrials.gov/study/NCT07038382?cond=HLX79&viewType=Table&rank=1

About Palleon Pharmaceuticals

Palleon Pharmaceuticals is the leading biotechnology company developing drugs that harness glyco-immunology to treat cancer and autoimmune diseases. The company’s proprietary platforms enable new target discovery, patient selection, and the development of novel therapeutics for devastating diseases characterized by immune system dysfunction. The groundbreaking discoveries of Palleon Co-Founder and Nobel laureate Carolyn Bertozzi enabled development of the company’s glycan degradation therapeutic platform. www.palleonpharma.com