The completion of clinical trial supply manufacture for a breast cancer treatment is a big step in accelerating PhoenixMD to Phase I readiness
Phoenix Molecular Designs and WuXi STA have reached a major milestone in their manufacturing agreement. The completion of clinical trial supply manufacture for a breast cancer treatment is a big step, accelerating PhoenixMD to Phase I readiness.
In March 2018, the companies entered into a major manufacturing agreement, and have since produced a multi-kilogram drug supply for PMD-026 under GMP manufacturing practices. The clinical trial supply that WuXi STA has provided is being used to support IND-enabling toxicology studies and an upcoming Phase I/Ib study in women with breast cancer.
PhoenixMD's lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). In order to further the collaboration, WuXi STA expanded its US operations to include capsule production under GMP regulatory compliance.
Dr Minzhang Chen, CEO of WuXi STA, said: "The opportunity to enable PhoenixMD's first-in-man studies came at an opportune moment for STA's San Diego facility."
"Our partnership with WuXi STA has been critical for PhoenixMD to advance this stage of our development. Working with such a high quality, globally recognised manufacturing partner has allowed us to rapidly advance PMD-026 through IND-enabling GLP toxicology studies and has enabled us to be ready to initiate our Phase I/Ib study with high-quality API in capsules," said Sandra E Dunn, CEO of PhoenixMD.
The drug supply is sufficient to treat all of the patients in the Phase 1 study. This is coupled with the completion of PhoenixMD's CDx for measuring activated RSK2 in tumours signals, enabling the two key elements needed for this precisely designed clinical trial to advance.