Palleon Pharmaceuticals and Henlius Partner to Develop Glycan Editing for Autoimmune Diseases

Palleon Pharmaceuticals, based in Waltham, Mass., has announced a strategic collaboration with Shanghai Henlius Biotech, Inc. This agreement focuses on the development and commercialization of Palleon's innovative sialidase enzyme therapeutic, E-602. The collaboration will explore the efficacy of E-602 when combined with Henlius' HANLIKANG (rituximab) for treating autoimmune conditions, specifically lupus nephritis.

Rituximab, an anti-CD20 monoclonal antibody, is a recognized treatment for several autoimmune diseases, but it often falls short in fully addressing patients' needs. Palleon's approach to glyco-immunology aims to fill this gap by targeting and enhancing the depletion of activated memory B cells, which are notoriously resistant to conventional treatments and play a crucial role in disease progression. E-602, by degrading sialoglycans, assists in overcoming the protective barrier of these immunosuppressive sugars, thereby enhancing the action of rituximab.

Preclinical studies suggest that the combination of E-602 with rituximab offers superior outcomes compared to rituximab alone. Notably, this combination does not carry the risks typically associated with other advanced therapies, such as cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). Moreover, E-602 has shown a promising safety profile in human trials, with no dose-limiting toxicities, making it a viable candidate for outpatient treatments.

Jim Broderick, M.D., CEO and founder of Palleon, expressed optimism about the partnership with Henlius, emphasizing the potential of their glycan editing therapy to significantly improve patient outcomes, particularly for those battling autoimmune diseases like lupus nephritis. This collaboration also aims to make the therapy accessible in community outpatient settings.

As part of the collaboration, Henlius has secured exclusive rights to E-602 in China. This deal could potentially yield Palleon up to $95.3 million through various development and commercial milestones, not to mention royalties upon E-602's commercialization in China. Henlius will be responsible for the development and funding of E-602 in conjunction with HANLIKANG for treating lupus nephritis.

This agreement builds on the existing collaboration between Palleon and Henlius, which began in June 2022. Their joint efforts in oncology focus on developing targeted sialidase therapies for cancer treatments. Dr. Jason Zhu, Executive Director and CEO of Henlius, expressed satisfaction with this expanded collaboration, emphasizing their commitment to providing better therapeutic options for patients with lupus nephritis and similar autoimmune diseases.

E-602 is a pioneering human sialidase enzyme therapeutic, born from Palleon's EAGLE glycan editing platform. HANLIKANG (rituximab), on the other hand, holds the distinction of being the first biosimilar developed and approved for an autoimmune indication in China.

Palleon Pharmaceuticals continues to lead in the field of glyco-immunology, focusing on the development of new therapeutics for diseases characterized by immune system dysfunction. The company owes its innovative edge partly to the groundbreaking work of co-founder and Nobel laureate, Carolyn Bertozzi.

Henlius, meanwhile, is a global player in biopharmaceuticals, aiming to provide high-quality, affordable, and innovative biologic medicines worldwide. Since its inception in 2010, Henlius has developed a diverse portfolio, with products launched across major global markets. They continue to explore combination therapies, particularly in immuno-oncology, leveraging their proprietary therapies.