• Palleon and Henlius to evaluate Palleon’s E-602 in combination with Henlius’ rituximab HANLIKANG in clinical studies for autoimmune diseases

• Henlius receives exclusive license to E-602 in China; Palleon retains all other global rights

• Partnership represents first clinical application 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, and E-602 safety in Phase I clinical studies

WALTHAM, Mass. & SHANGHAI, December 19, 2024 — Palleon Pharmaceuticals, a company pioneering glyco-immunology drug development to treat autoimmune diseases and cancer, today announced a collaboration and license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) to develop and commercialize Palleon’s first-in-class human sialidase enzyme therapeutic, E-602, in combination with Henlius’ self-developed HANLIKANG (rituximab) in patients with autoimmune diseases, including lupus nephritis (LN).

Depleting B cells with targeted antibodies such as rituximab (anti-CD20 mAb) is an established treatment for several autoimmune diseases, however, many patients have inadequate response to these drugs. Glyco-immunology provides a new approach to treating autoimmunity by enhancing depletion of activated memory B cells, the pathogenic subset of B cells associated with disease progression and often resistant to antibody-mediated depletion. E-602 enzymatically degrades sialoglycans—immunosuppressive cell surface sugars that protect pathogenic memory B cells from depletion by B cell-targeted antibodies.

Preclinical studies of E-602 in combination with rituximab demonstrate improved outcomes versus rituximab alone without the risk of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) associated with CAR T and T cell engagers.E-602 has demonstrated a favorable safety profile with no dose-limiting toxicities in human clinical trials, which makes it suitable for the outpatient community setting.

“Palleon’s glycan editing therapeutic has the potential to significantly improve treatment outcomes in patients who have autoimmune diseases including lupus nephritis, with a therapy that achieves optimal patient accessibility, including delivery in community outpatient settings,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “We look forward to continuing our successful partnership with Henlius and expanding glyco-immunology drug development to address a new category of patients in need of better treatment options.”

Under the terms of the agreement, Henlius received an exclusive China license to Palleon’s E-602. Palleon is eligible to receive up to $95.3 million in certain predetermined development and commercial milestones, in addition to royalties upon E-602 commercialization in China. Henlius shall perform and fund E-602 development in China in combination with HANLIKANG for the treatment of lupus nephritis. This partnership expands upon Palleon and Henlius’ ongoing collaboration in oncology formed in June 2022 to co-develop targeted sialidase therapies in cancer.

“We are pleased to expand our collaboration with Palleon Pharmaceuticals, the leader in the novel field of glyco-immunology,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “HANLIKANG is the only rituximab approved for an autoimmune indication in China. We are committed to bringing better therapies to patients who suffer from lupus nephritis and other autoimmune conditions for which current treatment options are not always sufficient.”

E-602 is a first-in-class human sialidase enzyme therapeutic developed from Palleon’s EAGLE glycan editing platform. HANLIKANG (rituximab) is the first-ever biosimilar developed and approved in China.

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