STA to manufacture PhoenixMD candidate for Ph I study

STA Pharmaceutical is manufacturing PhoenixMD’s kinase inhibitor drug candidate for IND-enabling toxicology studies and a Phase I study in women with triple-negative breast cancer.

Phoenix Molecular Designs (PhoenixMD), a biotechnology company designing “precise” cancer therapeutics by targeting essential kinases, recently announced a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company.

As per the agreement, STA will manufacture PMD-026 – a kinase inhibitor drug candidate for the treatment of triple-negative breast cancer (TNBC) – at its GMP-certified facility in San Diego, CA.

"It is critical to have a manufacturing partner at this stage of development for PMD-026,” said Gerrit Los, CSO of PhoenixMD.

“This collaboration will allow us to move PMD-026 into IND enabling toxicology studies and to get ready for a successful IND filing. Importantly, it provides us the security to have access to GMP quality API when we are ready to start our Phase I study,” he explained in a press release.

PhoenixMD expects to file an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) for PMD-026.

While the company is initially targeting TNBC, its platform of kinase inhibitor drug candidates is being developed treat a range of unmet medical needs, according to the company.