Palleon Pharmaceuticals Announces NMPA IND Clearance to Proceed with Phase 2 Clinical Trial of E-602 (HLX79), a First-In-Class Treatment for Autoimmune Diseases

• 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.

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 editing therapeutic platform. www.palleonpharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250402600282/en/