Patients in the study were evaluated for levels of tumour sialoglycan to determine the presence of hypersialylation. Credit: Volha_R / Shutterstock.

Palleon Pharmaceuticals has reported the outcomes from its Phase I/II study of E-602 along with programmed death (PD)-1 inhibitor cemiplimab (Libtayo) to treat patients with programmed death-ligand 1 (PD-(L)1)-resistant solid tumours.

The first-in-class human sialidase enzyme therapeutic E-602 is based on the company’s oncology platform, Enzyme Antibody Glyco-Ligand Editing (EAGLE).

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The Glycan-Mediated Immune Regulation (GLIMMER-01) study is a single-arm, open-label trial designed to assess the pharmacokinetics, safety, antitumour activity and tolerability of E-602.

It involved 21 participants with anti-PD-(L)1-resistant melanoma, esophagogastric junction cancer and non-small cell lung cancer who received the combination therapy treatment.

Patients in the study were evaluated for levels of tumour sialoglycan to determine the presence of hypersialylation.

The combination therapy was usually well-tolerated, and no dose-limiting toxicities were reported.

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Notably, participants with tumour hypersialylation exhibited better clinical outcomes than those without, including one confirmed partial response in participants with anti-PD-1 resistant melanoma, and disease stabilisation in six other participants.

Conversely, all participants lacking hypersialylation experienced disease progression.

Moreover, paired tumour biopsies from subjects with hypersialylation indicated tumour desialylation and immune modulation in tumours.

Palleon Pharmaceuticals CEO and founder Jim Broderick said: “E602 is the first candidate in a brand new class of therapeutics designed to modulate the immune system by targeting glyco-immunology.

“Palleon is building a rich pipeline of first-in-class drug candidates with the potential to improve and extend the lives of patients with diseases characterised by immune dysfunction, including cancer and autoimmunity.”

The first patient in the combination therapy cohort was dosed in June 2023, marking the commencement of the Phase I/II clinical trial for E-602.

Cemiplimab for the trial is supplied by Regeneron Pharmaceuticals.

Palleon Pharmaceuticals chief scientific officer Li Peng said: “The proof of mechanism and antitumor responses observed with E-602 as a combination therapy for patients with solid tumours further validate the therapeutic potential of targeting glyco-immunology to regulate the immune response in treating cancer and autoimmune diseases.”