Palleon Pharmaceuticals, a glyco-immunology drug development firm, has announced a new partnership with Shanghai Henlius Biotech (Henlius) to develop and commercialise the former’s E-602, a human sialidase enzyme therapeutic.

This collaboration and licence agreement aims to treat autoimmune diseases, including lupus nephritis (LN), using E-602 in combination with Henlius’ Hanlikang (rituximab). It builds on the ongoing collaboration between Palleon Pharmaceuticals and China-based Henlius, which began in June 2022, to co-develop targeted sialidase therapies for cancer.

E-602 works by enzymatically degrading sialoglycans, immunosuppressive sugars on cell surfaces that protect pathogenic memory B cells from B cell-targeted antibodies. It was developed on Palleon Pharmaceuticals’ Enzymatic and Antibody Glyco-Ligand Editing (EAGLE) platform.

Preclinical studies have shown that E-602 when combined with rituximab, delivers better outcomes than rituximab alone.

This combination bypasses the risks of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which are common with CAR T therapies and T cell engagers.

E-602 has shown a favourable safety profile in human clinical trials, with no dose-limiting toxicities, making it ideal for outpatient use.

Last month, Palleon Pharmaceuticals announced promising results from its Phase 1/2 trial of E-602 in combination with cemiplimab, targeting PD-(L)1-resistant solid tumours.

Palleon Pharmaceuticals CEO and founder Jim Broderick said: “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.

“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.”

As per the agreement, Henlius has obtained an exclusive licence for Palleon Pharmaceuticals’ E-602 in China. On the other hand, Palleon Pharmaceuticals retains all other global rights outside of China.

Palleon Pharmaceuticals stands to receive up to $95.3m in predetermined development and commercial milestones, along with royalties upon E-602’s commercialisation in China.

The Chinese biotech company will assume responsibility for funding and conducting E-602 development with Hanlikang for lupus nephritis.

Henlius executive director and CEO Jason Zhu said: “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.”

In October last year, Henlius expanded its licence agreement with India-based Intas Pharmaceuticals to commercialise serplulimab, a novel anti-PD1 monoclonal antibody (mAb) injection, in Europe and India.