Positive Phase 1 Data Support Near-term Initiation of Global Phase 2 Trial

Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced that data from the Phase 1 ACeD (Assessment of KAN-101 in Celiac Disease) clinical trial evaluating its lead candidate, KAN-101, for the treatment of individuals with celiac disease will be presented during an encore poster presentation on October 21, 2022, at 2:00 p.m. CET at the 19^th International Celiac Disease Symposium (ICDS). The Symposium is being held October 19-21, 2022, in Sorrento, Italy.

Celiac disease is a serious autoimmune disease triggered by ingestion of gluten for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. Findings from the ACeD trial showed that treatment with KAN-101 was safe and tolerated in patients treated, and reduced T cell responses following a gluten challenge. Based on the results from the Phase 1 trial, Anokion is preparing to initiate a global Phase 2 trial of KAN-101 in patients with celiac disease.

“The data observed in our Phase 1 trial with KAN-101 are highly encouraging, demonstrating clear reduction of T cell responses, and a dose-dependent inhibition of gluten-induced serum IL-2 (interleukin-2), a key disease biomarker that may correlate with the timing and severity of symptoms after gluten exposure in celiac disease,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion. “These data suggest that our KAN-101 product candidate could be the first disease-modifying approach to treating celiac disease. Based on these findings, we are working closely with our global sites to prepare for patient enrollment in a global Phase 2 clinical trial by the end of the year, taking us a critical step forward to bringing a potential life-changing treatment to individuals with celiac disease.”

Presentation Details

Title: Liver-Targeted KAN-101 Induces Gliadin-Specific Immune Tolerance in Celiac Disease: Safety, Tolerability, and Pharmacodynamic Assessments of a Phase 1 Trial

Date & Time: October 21, 2022, from 2:00-3:00 p.m. CET

About KAN-101

KAN-101 is an investigational therapy being evaluated as a treatment for individuals with celiac disease, a serious autoimmune disease triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. KAN-101 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of celiac disease.

About Anokion

Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease. For more information, please visit http://www.anokion.com/.

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