Palleon Pharmaceuticals Announces First Patient Dosed with E-602 in Combination with Cemiplimab in GLIMMER-01 Phase 1/2 Clinical Trial

- Combination therapy cohort initiated in Palleon’s ongoing study to evaluate safety, pharmacodynamic effects, and antitumor activity of its lead glyco-immunology candidate in patients with advanced cancer

- E-602 being evaluated in combination with cemiplimab (Libtayo®) as part of clinical trial supply agreement with Regeneron

Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, today announced that the first patient has been dosed in the combination therapy cohort of the Phase 1/2 clinical trial for E-602, its lead candidate from the EAGLE (Enzyme Antibody Glyco-Ligand Editing) oncology platform. The GLIMMER-01 (Glycan-Mediated Immune Regulation) trial is designed to study E-602 as a monotherapy and in combination with cemiplimab (anti-PD-1) in patients with advanced cancers.

“With E-602, we are investigating an entirely new approach to oncology, one that we feel has potential benefits both as a monotherapy and in combination with other anti-cancer agents,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “We are pleased to work with Regeneron to evaluate E-602 in combination with cemiplimab. We expect this trial to provide valuable information as we look to understand the benefits that targeting sialoglycans can bring to advancing the field of oncology and ultimately improving the outlook for patients.”

E-602 is a first-in-class glyco-immune checkpoint inhibitor developed by Palleon and designed to enzymatically degrade immunosuppressive cell-surface sugars on tumors and immune cells. GLIMMER-01 is an open-label, single-arm, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic, and antitumor activity of E-602. Regeneron is providing cemiplimab for the trial as part of a clinical supply agreement initiated earlier this year.

Palleon recently announced Phase 1 results from the GLIMMER-01 trial of E-602 as a monotherapy at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida. The study demonstrated proof of mechanism for E-602, including dose dependent desialylation and dose dependent immune system activation. Additionally, E-602 was found to be well tolerated across the entire dose range evaluated with no dose limiting toxicities.

About Palleon Pharmaceuticals

Palleon Pharmaceuticals, co-founded by Nobel laureate Carolyn Bertozzi, is a biotechnology company pioneering glyco-immunology drug development to transform the treatment of cancer and inflammatory diseases. The Company’s proprietary platforms overcome technical barriers unique to glycobiology to enable drug discovery, patient selection, and indication prioritization to de-risk clinical development. The company’s lead program in oncology, E-602, is a first-in-class, glyco-immune checkpoint inhibitor which restores antitumor immunity by enzymatically degrading immunosuppressive sialoglycans on hypersialylated tumors and immune cells. It is being evaluated in a Phase 1/2 clinical trial. Palleon has a rich pipeline of additional drug candidates including several advancing toward IND-enabling studies.

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