Manufacturing collaboration to advance PMD-026 toward IND

MD-026 is the first RSK inhibitor to demonstrate potential disease-modifying properties in triple-negative breast cancer.

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. Through these collaborative efforts, PhoenixMD expects to file an Investigational New Drug Application (IND) with the FDA for PMD-026.

Dr Minzhang Chen, CEO of STA, commented: "We are excited to manufacture PMD-026 and enable PhoenixMD to advance this novel RSK inhibitor to shrink tumors in Phase 1 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 signaling and initiating significant tumor 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."