WALTHAM, Mass.– Palleon Pharmaceuticals has received clearance from the China National Medical Products Administration (NMPA) to proceed with a Phase 2 clinical trial of its first-in-class human sialidase enzyme therapeutic, E-602 (HLX79). The trial, conducted in partnership with Shanghai Henlius Biotech, will evaluate E-602 in combination with Henlius’ HANLIKANG, a rituximab biosimilar, in patients with active glomerulonephritis, including lupus nephritis.
This approval marks a significant milestone as it initiates the first clinical trial utilizing Palleon’s glyco-immunology platform for autoimmune diseases. Preclinical studies have demonstrated that E-602 enhances the efficacy of rituximab, depleting autoreactive memory B cells and reducing dysfunctional macrophages, which contribute to tissue damage and scarring following autoimmune flares. Additionally, Phase 1 trials indicated that E-602 has a favorable tolerability and safety profile as a monotherapy.
“Glyco-immunology provides an entirely new approach to treating autoimmune disorders,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “E-602 (HLX79) has the potential to improve patient outcomes while maintaining accessibility for outpatient care. We are eager to collaborate with Henlius on this Phase 2 trial, the most advanced evaluation of E-602 to date, and to advance innovative treatments in this challenging field.”
The upcoming Phase 2 study is part of a broader collaboration between Palleon and Henlius, announced in December 2024, to explore the potential of E-602 in combination with rituximab for autoimmune disease treatment. Preclinical research has shown that this combination achieves enhanced B cell depletion without the risks associated with CAR T and T cell engager therapies, such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. The safety and efficacy profile of E-602 makes it a promising candidate for outpatient settings, offering a novel therapeutic option for patients with autoimmune diseases.
The initiation of this trial underscores the potential of glyco-immunology in revolutionizing autoimmune disease treatment and expanding therapeutic possibilities for patients worldwide.
