Palleon Pharmaceuticals, a clinical-stage company leading innovation in glyco-immunology for autoimmune diseases and cancer, today announced results from the Phase 1/2 GLIMMER-01 trial of E-602. This first-in-class human sialidase enzyme therapeutic was tested in combination with the PD-1 inhibitor cemiplimab (Libtayo®) in patients with PD-(L)1-resistant solid tumors. The findings will be presented in both rapid oral and poster sessions on Saturday, November 9, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas.
Palleon Pharmaceuticals today shared results from the Phase 1/2 GLIMMER-01 study of E-602, its first-in-class human sialidase enzyme therapeutic, in combination with the PD-1 inhibitor cemiplimab (Libtayo®). The trial, which focused on patients with anti-PD-(L)1-resistant solid tumors, including melanoma, non-small cell lung cancer (NSCLC), and esophagogastric junction cancer, was presented at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas.
The study enrolled 21 patients whose tumors were resistant to PD-(L)1 inhibitors, based on the SITC consensus definition for immunotherapy resistance. Patients were treated with E-602 and cemiplimab, and tumor sialoglycan levels were assessed to identify whether tumors exhibited hypersialylation. Tumors with hypersialylation trended toward better clinical outcomes compared to those without, including a confirmed partial response in one melanoma patient and disease stabilization in six others. Conversely, all patients without hypersialylation experienced disease progression.
The combination treatment was generally well-tolerated, with no dose-limiting toxicities observed. Tumor biopsies from patients with hypersialylation showed evidence of tumor desialylation and immune modulation. However, the effect of tumor desialylation was short-lived, lasting only 2-3 days with weekly dosing. These findings offer the first proof of mechanism for glycan editing as a novel approach to modulating the immune system in cancer treatment.
“We are excited to see the proof of mechanism and early antitumor responses observed with E-602 in combination with cemiplimab,” said Li Peng, Ph.D., Chief Scientific Officer of Palleon Pharmaceuticals. “These results further validate the potential of glyco-immunology as a therapeutic strategy for regulating immune responses in both cancer and autoimmune diseases. We look forward to advancing E-602 in clinical applications and developing our next-generation EAGLE molecules with extended half-lives and tumor-targeting capabilities to address the unmet needs of cancer patients.”
Jim Broderick, M.D., CEO and Founder of Palleon, added, “E-602 represents the first candidate in a groundbreaking class of therapeutics that target glyco-immunology to modulate immune responses. Palleon is building a robust pipeline of first-in-class drug candidates aimed at improving the lives of patients suffering from diseases driven by immune dysfunction, including cancer and autoimmunity.”
The full study results will be available on Palleon’s website in the Publications section of the Education Hub following the official presentation on November 9.
About Palleon Pharmaceuticals
Palleon Pharmaceuticals is a leading biotechnology company developing therapies that leverage glyco-immunology to treat cancer and autoimmune diseases. The company’s proprietary platforms enable the discovery of new therapeutic targets, patient selection strategies, and the development of novel treatments for diseases characterized by immune system dysfunction. Palleon’s EAGLE glycan editing platform, developed through the groundbreaking work of co-founder and Nobel laureate Carolyn Bertozzi, powers the company’s innovative drug development efforts.
