- Palleon and Henlius to evaluate Palleon’s E-602 (HLX79) in combination with Henlius’ HANLIKANG (rituximab) in clinical trials for autoimmune diseases including lupus nephritis
- NMPA approval will initiate the first clinical trial of Palleon’s glyco-immunology platform in autoimmune diseases, building on pre-clinical studies demonstrating enhanced efficacy of rituximab when used in combination with E-602 (HLX79), as well as Phase 1 data showing a favorable tolerability and safety profile of E-602 (HLX79) as a monotherapy
Palleon Pharmaceuticals, a company pioneering glyco-immunology drug development to treat autoimmune diseases and cancer, today announced that the China National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech’s Investigational New Drug (IND) application for a Phase 2 clinical trial of Palleon’s first-in-class human sialidase enzyme therapeutic, E-602 (HLX79), in combination with Henlius’ self-developed HANLIKANG (rituximab biosimilar) in patients with active glomerulonephritis, including lupus nephritis (LN). With this clearance, Henlius will initiate the first clinical trial of Palleon’s glyco-immunology platform in autoimmune diseases.
Autoimmune diseases occur when the body’s immune system mistakenly attacks its own healthy tissues. E-602 is designed to reduce the prevalence of two immune cell types involved in autoimmunity, autoreactive memory B cells and dysfunctional M2 macrophages. E-602 can be added to the administration of any B cell-targeted antibody, enhancing the depletion of autoreactive memory B cells. E-602 also reduces dysfunctional macrophages which cause tissue damage and scarring after an autoimmune flare. E-602’s unique dual mechanism, which has been demonstrated in preclinical and early clinical experiments, is expected to reduce the severity of autoimmune flares and improve treatment response.
“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 pair improved patient outcomes with optimal accessibility, including delivery in community outpatient settings. We look forward to partnering with Henlius on this Phase 2 clinical trial, the most advanced trial of E-602 (HLX79) thus far, and developing a new category of medicines for this challenging disease space.”
Preclinical studies of E-602 (HLX79) in combination with rituximab demonstrate enhanced B cell depletion versus rituximab alone without the risk of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS), which have been associated with CAR T and T cell engager therapies for the elimination of autoreactive B cells. E-602 (HLX79) demonstrated a favorable safety profile with no dose-limiting toxicities in a completed Phase 1 clinical trial, which makes it suitable for the outpatient community setting.
The Phase 2 trial will be run under a collaboration between Palleon and Henlius, announced in December 2024, to evaluate Palleon’s E-602 (HLX79) in combination with Henlius’ rituximab HANLIKANG in clinical studies for autoimmune diseases.
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
