Shanghai and Waltham, Massachusetts, December 19, 2024—HENLIUS (2696.HK) announced a collaboration and licensing agreement with Palleon Pharmaceuticals Inc. ("Palleon") to develop and commercialize Palleon's first-in-class human sialidase fusion protein E-602 in combination with HENLIUS's independently developed Hanlikang (rituximab) for the treatment of autoimmune diseases, including lupus nephritis (LN). Palleon is a leading company focused on the development of glyco-immunotherapies for the treatment of cancer and inflammatory diseases.

B cell depletion therapies represented by targeted antibodies such as rituximab (anti-CD20 monoclonal antibody) have become established treatments for various autoimmune diseases. However, the therapeutic response to such drugs is not ideal for many patients. Memory B cells are a pathogenic B cell subpopulation associated with the progression of autoimmune diseases and are often linked with resistance to antibody-mediated B cell depletion therapies. By enhancing the depletion of memory B cells, glyco-immunotherapy offers a new approach to treating autoimmune diseases. E-602 can enzymatically degrade sialylated glycans, which are immunosuppressive sialic acid polysaccharides expressed on cell surfaces and serve to protect pathogenic memory B cells from depletion by B cell-targeting antibodies.

Preclinical studies have shown that the efficacy of E-602 in combination with rituximab is significantly improved compared to rituximab alone, and does not cause cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to CAR-T Therapy or T cell engagers. In previous clinical trials, E-602 demonstrated favorable safety characteristics, with no dose-limiting toxicity, and has the potential for use in outpatient settings.

Palleon's Chief Executive Officer and Founder

Dr. Jim Broderick

Palleon's glyco-editing therapy is expected to significantly improve the treatment outcomes for patients with autoimmune diseases, including lupus nephritis, and to meet patients' needs for accessibility through convenient application in community outpatient settings. We look forward to deepening our successful collaboration with HENLIUS to expand the development of glyco-immunotherapies to new patient populations and bring hope to patients in urgent need of better treatment options.

Under the terms of the agreement, HENLIUS obtains exclusive rights to E-602 in China. Palleon is eligible to receive up to $95.3 million in development and commercialization milestone payments, as well as sales royalties after E-602's commercialization in China. HENLIUS will be responsible for the clinical development of E-602 in combination with Hanlikang for the treatment of LN in China and will bear the corresponding costs. This collaboration further expands the partnership between HENLIUS and Palleon. In June 2022, both parties reached an agreement to jointly explore the application of dual-functional sialidase fusion proteins in tumor treatment.

HENLIUS Executive Director and CEO.

Dr. Zhu Jun.

We are pleased to further expand cooperation with Palleon, a leader in the emerging field of carbohydrate immunity. HANKANG is currently the only rituximab product approved for the treatment of autoimmune diseases in China. We will continue to explore and strive to provide better treatment options for patients with lupus nephritis and other autoimmune diseases that have insufficient existing treatment methods.

It is reported that E-602 is a first-in-class human sialidase fusion protein developed on Palleon’s EAGLE glycoediting platform. HANKANG (rituximab) is the first biosimilar drug independently developed and approved for marketing in China.

Palleon Pharmaceuticals is a leading biotechnology company dedicated to developing carbohydrate-mediated immune modulation therapies for treating cancer and inflammatory diseases. The company's proprietary platform supports new target discovery, patient selection, and the development of novel therapies for destructive diseases characterized by immune system dysfunction. The groundbreaking discoveries of Palleon co-founder and Nobel Prize winner Carolyn Bertozzi contributed to the development of the company's glycoediting platform.