Comprehensive Report on AIV-001: An Investigational Multi-Kinase Inhibitor Formulation for Dermatological Applications

1. Executive Summary

AIV-001 is an investigational therapeutic agent under development by AiViva Biopharma Inc. It represents a novel formulation of axitinib, a known multi-kinase inhibitor, combined with AiViva's proprietary delivery technology engineered for prolonged drug release following intradermal administration. The mechanism of action involves the inhibition of multiple kinases, including Vascular Endothelial Growth Factor Receptors (VEGFR), thereby targeting key pathways implicated in neovascularization, abnormal cell proliferation, inflammation, and fibrosis.

Currently, AIV-001 is primarily being investigated for dermatological applications, specifically the non-surgical treatment of nonmelanoma skin cancer, with a focus on basal cell carcinoma (BCC), and the management or prevention of dermal scarring and wound healing. Potential applicability in rosacea has also been suggested based on its mechanism. Completed Phase I/II clinical trials have provided preliminary evidence supporting its potential utility. In studies involving patients with BCC, AIV-001 demonstrated histological and clinical clearance of lesions with good local tolerability. In scar models, it showed a reduction in fibrosis formation. A significant regulatory milestone was achieved in late 2024 with the U.S. Food and Drug Administration (FDA) granting clearance for AIV-001 to be tested via intradermal injection in facial skin for BCC, based on safety data from previous non-facial studies. Despite these promising early results, AIV-001 remains an investigational product and has not yet received marketing approval from any regulatory agency.

2. AIV-001: Background and Formulation

2.1 Introduction to AIV-001