Microbix Biosystems announces advancement of clot-buster drug project

Microbix Biosystems (MBXBF) announces that the contract development and manufacturing organization engaged by its funding and commercialization partner, Sequel Pharma, has modernized production methods for the active ingredient of Kinlytic urokinase, a biologic for dissolving blood clots. Sequel is a U.S. based specialty pharma company with expertise in developing and commercializing niche drugs. It has committed to provide all funding needed to return Kinlytic to global markets, initially for the U.S. market for dissolving clots in indwelling venous catheters. Kinlytic’s active ingredient is an enzyme derived from cell culture that safely dissolves blood clots. Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of filing a supplemental biologics license application. In March 2024, a CDMO was engaged by Sequel to modernize aspects of Drug Substance manufacturing of Kinlytic – Specifically to reduce or eliminate the use of products of animal origin in cell culturing media. This relates to modern best-practices and is an extra safety precaution above cell-source and medium ingredient screening and manufacturing processes for product purification. Work toward the sBLA filing is progressing as expected, is in accordance with FDA guidance, and is proceeding into the formulation, fill, and finish “Drug Product” phases of development. Microbix’s intends to continue updating its shareholders on further Kinlytic-related achievements as they become meaningful. Anticipated future disclosures related to Kinlytic may include, among other matters, other manufacturing, clinical, regulatory, or commercial milestones.