Microbix partner Sequel continues work on Kinlytic

Executive Summary

• Microbix Biosystems reports significant progress in the modernization of manufacturing for Kinlytic urokinase, a biologic drug for dissolving blood clots, through its partner Sequel Pharma LLC.
• The contract development and manufacturing organization (CDMO) has successfully modernized production methods for the active ingredient to reduce or eliminate animal-origin products in cell-culturing media, aligning with modern best practices and FDA guidance.
• Development is progressing into the formulation, fill, and finish phases, with the goal of filing a supplemental biologics licence application (sBLA) to re-enter the U.S. market, targeting a timeline of calendar 2028.

Key Details

• Manufacturing Modernization: The CDMO engaged by Sequel Pharma has modernized production methods for the Kinlytic active ingredient (drug substance).
• Specific Technical Update: The modernization specifically targets the reduction or elimination of products of animal origin in cell-culturing media.
• Safety Context: This change serves as an extra safety precaution beyond existing cell-source and medium ingredient screening and manufacturing processes for product purification.
• Regulatory Path: The work supports the filing of a supplemental biologics licence application (sBLA) to return Kinlytic to global markets, initially for the U.S. market for dissolving clots in indwelling venous catheters (catheter clearance).
• Current Phase: Work toward the sBLA filing is proceeding into the formulation, fill, and finish drug product phases of development.
• Timeline: The targeted timeline for reapproval and reintroduction is calendar 2028.
• Partnership: Sequel Pharma LLC is providing all financing needed to return Kinlytic to global markets.

Notable Quotes

• Cameron Groome, CEO and President: "We're pleased to report this important progress toward the reapproval and reintroduction of Kinlytic, initially for catheter clearance in the United States... we are excited about the prospect of returning this medically important drug to widespread clinical use, with a targeted timeline of calendar 2028..."
• Dr. Ken Hughes, COO: "It remains a pleasure to be working alongside Sequel... we believe that the recently completed drug substance work has cleared pivotal and technically challenging hurdles."