MKC Biotherapeutics, Inc.
MKC Biotherapeutics is a therapeutics company, operationalized in June 2024. The company is focused on regenerative medicine applications using “disease modifying” cell-based drugs for treatment of chronic & age-related diseases.
Our business model is to identify & in-license therapeutic platforms / product assets with demonstrated human safety & efficacy data (with durable clinical benefit) and undertake any required bridging clinical / regulatory development for purposes of commercial marketing approval in US & Europe.
Our current Product Portfolio consists of our first in-licensed IP, technology & know-how along with clinical data(pivotal trials & RWE from commercial treatment) for an allogeneic Mesenchymal Stromal Cell (MSC) platform that has resulted in regulatory approval for three disease indications in India. The licensed IP, technology and know how provides robust, scalable, cost-effective, industrial scale manufacture with consistent biological activity and potency. These attributes enable commercial delivery of disease-modifying cell-based drugs along conventional pharmaceutical drug product margins. We have elected to pursue knee osteoarthritis as our lead indication for US commercial development and anticipate IND filing in mid-2026 for an adaptive Phase 2/3 trial design as pivotal study for BLA filing / licensure.
