The drug candidate from Phoenix Molecular Designs, PMD-026, the first RSK inhibitor therapy for triple-negative breast cancer (TNBC), will enter the clinic in an upcoming Phase I/Ib study in women with breast cancer in the third quarter of 2019. The drug will also enter a toxicology study for investigational new drug (IND) application purposes.
STA Pharmaceutical, a subsidiary of WuXI STA, completed the manufacturing of the clinical supply of the drug product after the two companies entered an agreement in March 2018. STA produced a multi-kg drug supply of the candidate under good manufacturing practices (GMP) practices which is sufficient to treat all patients in the clinical trial.
The collaboration, which PhoenixMD said was a critical part of advancing the drug candidate to the clinic, will continue as WuXi STA recently expanded its operations in the US to include capsule production under GMP regulatory compliance.
According to Sandra Dunn, CEO of PhoenixMD, metastatic TNBC, for which PMD-026 is a treatment, is the most deadly type of breast cancer. She added that PMD-026 is the first drug to ever reach clinical use against this novel target.
As a ribosomal S6 kinase (RSK) inhibitor therapy, PMD-026 works on the kinase protein that drives the growth of the breast cancer subtype relative to the hormone positive or HER-2 positive breast cancer. The company stated that the candidate is also applicable to greater than 14 different types of cancers.