MTL-005 has a well characterised chemistry and an established GMP-compliant manufacturing process.
Scalable Manufacturing Process
MTL-005 offers a GMP-compliant, scalable synthetic manufacturing process using well established manufacturing and analytical methods. This presents major advantages for reduced capital investment requirements. A competitive cost of goods offers pricing flexibility at attractive gross margins to a commercial partner.
Stable Product with Long Shelf Life
The Drug Product is a kit comprising the Drug Substance plus two solvents used for reconstitution. The kit has an initial shelf life of at least 27 months at room temperature. Administration is via slow intravenous infusion, which can be given to the patient anywhere from 3 to 7 days prior to initiating the radiation treatment. A single dose of MTL-005 is expected to be sufficient for the duration of a multi-week course of radiotherapy.