Canadian biotech company Phoenix Molecular Designs (PhoenixMD) and partner STA Pharmaceutical (WuXi STA), a Chinese contract development and manufacturing organization (CDMO), have finished production of a multi-kilogram supply of PMD-026 for upcoming clinical trials.

PMD-026 is PhoenixMD’s lead candidate drug and the first RSK inhibitor to treat triple-negative breast cancer (TNBC), a particularly aggressive form of the disease. RSKs are a family of protein kinases that regulate diverse cellular processes, including cell growth and proliferation, and they are commonly associated with refractory cancers such as TNBC, hormone-refractory prostate cancer and resistant melanoma.

According to PhoenixMD, around 400,000 cases of TNBC are diagnosed every year worldwide, and it is one of the most difficult breast cancer subtypes to treat because of the lack of effective, targeted therapies.

The companies entered into a manufacturing agreement for PMD-026 in March 2018. WuXi STA, a subsidiary of WuXi AppTec, expanded its US operations to include capsule production (in compliance with GMP regulations). “The opportunity to enable PhoenixMD’s first-in-man studies came at an opportune moment for STA’s San Diego facility,” said Minzhang Chen, WuXi STA’s CEO.

Sandra Dunn, PhoenixMD’s CEO, added that the partnership with the Chinese CDMO has been critical to advance this stage of the drug’s development. She commented: “The rapid achievement of this milestone brings us one step closer to initiating our study for women suffering from breast cancer. More specifically, metastatic triple-negative breast cancer, which is the most deadly type of breast cancer. RSK is a promising new drug target for the treatment of TNBC, and PMD-026 is the first drug to ever reach clinical use against this novel target.”

The volumes manufactured are enough to treat all the patients in the Phase 1 study, which is scheduled to start in the third quarter of this year. PhoenixMD added that it has also completed its companion diagnostic for measuring activated RSK2 in tumors signals, enabling the two key elements for this “precisely designed” clinical trial to advance.  The diagnostic was developed in collaboration with Swiss drugmaker Roche.

According to PhoenixMD, preclinical studies have shown that PMD-026 shrank tumors by more than 70% as a single agent after only two weeks of treatment in tumors with high RSK2 activation.

Last month, WuXiAppTec announced that it had acquired US clinical research services company Pharmapace. Located in San Diego, California, Pharmapace provides biometrics services for all clinical trial phases.