The WuXi AppTec company will produce PMD-026 for IND-enabling toxicology studies and a Phase I study in women.

Triple Negative Breast Cancer (TNBC) does not currently have any approved targeted treatments. Approximately 170,000 cases of TNBC are diagnosed every year worldwide. Pharmaceutical company Phoenix Molecular Designs (PhoenixMD) is focused on developing a targeted therapy that will not only destroy these cancer cells, but prevent the cancer from returning by inhibiting cancer stem cells (CSCs).

PhoenixMD’s approach involves the inhibition of kinases, and in particular, blocking the activity of the specific kinase that is responsible for the growth of each cancer type. For TNBC, RSK1 and RSK2 are two of 518 human kinases that have proven to be critical to the survival of TNBC patients. The company is developing RSK inhibitors and companion diagnostics for TNBC, as well as for other cancers including blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

The company’s lead candidate PMD-026 is ready to move into toxicology studies that will enable an investigational new drug (IND) filing with the US Food and Drug Administration followed by a phase 1 study for TNBC in women.

PhoenixMD, therefore, recently entered into a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company to manufacture PMD-026 for use in these studies. STA will be PhoenixMD’s manufacturing partner for the company’s platform of kinase inhibitor drug candidates. Materials will be produced at STA’s GMP-certified site in San Diego, CA. 

"It is critical to have a manufacturing partner at this stage of development for PMD-026. This collaboration provides us the security to have access to GMP quality API when we are ready to start our Phase I study," said Gerrit Los, CSO of PhoenixMD.

Added PhoenixMD CEO Sandra E. Dunn: "We're thrilled to collaborate with STA, a global leader in drug development and manufacturing, who has helped us achieve an important milestone in the efficient and scalable manufacturing of PMD-026. Through this work, we have demonstrated that PMD-026 has the potential to be disease-modifying with its ability to block the RSK pathway signaling and initiating significant tumor shrinkage of up to 70% in TNBC xenograft models.”