Jupiter, FL – [August 31st, 2024] – Myosin Therapeutics is pleased to announce that it has successfully completed a Good Manufacturing Practice (GMP) drug substance manufacturing campaign, yielding several kilograms of GMP MT-125 material. This achievement marks a significant step forward in the preparation for Myosin’s upcoming clinical trials of MT-125.
The GMP manufacturing campaign was completed in a remarkably short time due to additional process development and optimization efforts. These optimizations not only accelerated the production timeline, but also ensured production of high-quality, consistent drug substance that meets the stringent regulatory standards for clinical use. The resulting GMP campaign provides sufficient material to support Myosin Therapeutics’ planned Phase 0/1b clinical trials and other developmental activities.
“This successful and rapid manufacturing campaign is a crucial milestone in our clinical development program for MT-125,” said Dr. Ted Kamenecka, who oversees chemistry, manufacturing and control activities at Myosin Therapeutics. “Technical expertise and process optimizations have led us to high-quality GMP material in record time, positioning us well for our upcoming clinical trials.”
With the GMP material now secured, Myosin Therapeutics is preparing to initiate Phase 0/1b clinical trials for MT-125 at the beginning of 2025. The study represents a key step in Myosin’s mission to bring innovative treatments to patients with this aggressive form of brain cancer.
About Myosin Therapeutics
Myosin Therapeutics is a Jupiter, FL-based biotechnology company spun out of the Herbert Wertheim UF Scripps Institute (formerly Scripps Research, Florida). The company is focused on developing therapies for central nervous system and oncology indications with a platform for targeting molecular nanomotor proteins. Myosin’s lead programs for glioblastoma and stimulant use disorder target non-muscle myosin II motor proteins.
For more information, email contact@myosintherapeutics.com
