Phoenix Molecular Designs (PhoenixMD), a privately held biotechnology company designing precise cancer therapeutics by targeting essential kinases, has entered into a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company, to manufacture the PMD-026 needed for IND-enabling toxicology studies and a Phase I study in women
Under the terms of the collaboration agreement, STA will become a new manufacturing partner for PhoenixMD for their platform of kinase inhibitor drug candidates to treat a wide range of unmet medical needs, with an initial focus on triple negative breast cancer (TNBC).
STA will be responsible for the early manufacturing work through their GMP-certified site in San Diego (CA, USA).
Through these collaborative efforts, PhoenixMD expects to file an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) for PMD-026.
Dr Minzhang Chen, CEO of STA, commented: "We are excited to manufacture PMD-026 and enable Phoenix MD to advance this novel RSK inhibitor to shrink tumours in Phase I studies in women."
"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," said Sandra E. Dunn, CEO PhoenixMD.
"Through this work, we have demonstrated that PMD-026 has the potential to be disease-modifying with its ability to block the RSK pathway signalling and initiating significant tumour shrinkage of up to 70% in TNBC xenograft models."
"Looking ahead, we expect to build upon this progress and file an IND for PMD-026, with the ultimate goal of confirming these revolutionary results in women suffering from TNBC."
Gerrit Los, CSO of PhoenixMD, added: "It is critical to have a manufacturing partner at this stage of development for PMD-026."
"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."