Pipeline

F-652
Introduction

IL-22 is produced by activated immune cells in response to inflammation or infection and primarily acts on epithelial cells and stroma cells through binding to its receptors selectively expressed on the surface of these cell types. Once bound to its receptors, IL-22 promotes proliferation, remodeling, and repairing of various tissues and organs to maintain innate host defense mechanisms that control the invasion of pathogens. IL-22 plays a broad role in protecting damages to barrier integrity and tissue homeostasis induced by a variety of pathogens such as viruses, bacteria, and chemicals.

IL-22 still remains a novel target without any drugs launched on the market. However, numerous studies have shown the wide bandwidth of IL-22’s relationship with various inflammatory diseases. Generon is a leading developer in this field and is one of two companies worldwide to develop IL-22 through Phase II clinical trials.

Our leading drug in this field, F-652, is an IL-22-Fc fusion protein under development. F-652 is a recombinant fusion protein consisting of a human interleukin 22 (IL-22) moiety and a human IgG2 Fc moiety. F-652 is manufactured in Chinese Hamster Ovary (CHO) cells. It exists as a homodimer. F-652 is a first-in-class biological drug.

F-652 clinical development status
F-652 takes advantage of IL-22’s natural epithelial cell growth promoting activity to combat organ injuries induced by a variety of causes and eventual fatal organ failures. Published literature and Evive’s completed clinical trials have presented F-652 with opportunities to treat multiple diseases, some of which Evive is actively pursuing or developing, including:

1. Continued development demonstrating safety and efficacy to treat acute graft vs host disease (GvHD) under FDA Orphan Drug Designation Program based on the safety and efficacy profile already obtained from completed aGvHD Phase IIa trial.

2. Continued development demonstrating safety and efficacy to treat acute alcoholic hepatitis based on the safety and efficacy profile already obtained from completed AH Phase IIa trial.

Study Subject Objective Country Status
Ph I Healthy men Safety & PK Australia Completed
Ph I Healthy men Safety & PK CFDA Completed
Ph I Healthy Volunteer Safety & PK FDA Initiating
Ph Ila Acute Alcoholic Hepatitis Safety & PK FDA Completed
Ph Ila AGvHD Safety & PK FDA Completed*

*Orphan drug status granted by FDA based on the efficacy data