Palleon Pharma Presents Phase 1/2 GLIMMER-01 Trial Results of E-602 with Cemiplimab in Solid Tumor Patients at SITC Annual Meeting

WALTHAM, Mass.--(BUSINESS WIRE)--Palleon Pharmaceuticals, a clinical-stage company dedicated to glyco-immunology drug development for autoimmune diseases and cancer, has revealed promising results from its Phase 1/2 GLIMMER-01 trial involving E-602, a first-in-class human sialidase enzyme therapy. This therapy has been tested in conjunction with the PD-1 inhibitor cemiplimab (Libtayo®) on patients resistant to PD-(L)1 therapies. The findings will be presented both orally and through posters on November 9 at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas.

The Phase 1/2 study encompassed 21 patients suffering from anti-PD(L)-1-resistant melanoma, non-small cell lung cancer, and esophagogastric junction cancer, as defined by the SITC consensus for immunotherapy resistance. These patients were administered a combination of E-602 and cemiplimab. Tumor sialoglycan levels were assessed in all participants, leading to their classification based on the presence or absence of hypersialylation. The combination treatment was generally well-received, with no significant toxicities noted. Notably, those with tumor hypersialylation exhibited more favorable clinical outcomes. One patient with anti-PD-1 resistant melanoma experienced a confirmed partial response, while six others achieved disease stabilization. Conversely, patients without hypersialylation showed disease progression.

Further insights were gained from paired tumor biopsies of hypersialylated patients, which demonstrated tumor desialylation and immune modulation post-treatment. However, the tumor desialylation effect persisted only for 2-3 days following weekly doses. These observations mark the first instance of proving the mechanism for glycan editing as a novel therapeutic strategy for immune system modulation.

Li Peng, Ph.D., Chief Scientific Officer of Palleon Pharmaceuticals, commented on the findings, asserting that the antitumor responses and proof of mechanism observed with E-602 in combination therapy bolster the potential of targeting glyco-immunology in cancer and autoimmune disease treatment. He emphasized the aim to leverage E-602’s pharmacological characteristics to address related diseases and to advance next-generation EAGLE molecules, which feature a longer half-life sialidase and a tumor-targeting component, to meet the unmet needs of cancer patients.

Jim Broderick, M.D., CEO and Founder of Palleon, highlighted E-602's status as the inaugural candidate in a new therapeutic class designed to modulate immune responses through glyco-immunology. He underscored Palleon’s commitment to developing a robust pipeline of unique drug candidates aimed at improving and extending lives affected by diseases driven by immune dysfunction, such as cancer and autoimmunity.

The detailed results of this study will be accessible on the Palleon Publications section of the Education Hub page on Palleon’s website following their official presentation on November 9.

Palleon Pharmaceuticals is at the forefront of biotechnology, focusing on creating drugs that leverage glyco-immunology to tackle cancer and autoimmune diseases. Their proprietary platforms facilitate new target discovery, patient selection, and the development of innovative treatments for serious diseases caused by immune system dysfunction. The pioneering work of Palleon Co-Founder and Nobel laureate Carolyn Bertozzi has been instrumental in the development of the company's EAGLE glycan editing therapeutic platform.