PCM-075 is an oral, investigative, highly-selective polo-like kinase 1 (PLK1) inhibitor for the treatment of acute myeloid leukemia (AML). Polo-like kinases are a family of serine-threonine kinases that regulate multiple intracellular processes including DNA replication, mitosis, and stress response. We believe that PCM-075 provides us the opportunity to bring a first-in-class PLK1 inhibitor to the market.
What Makes PCM-075 Such an Attractive Drug Candidate?
PLK1, the most well understood family member, is over expressed in many cancers, including AML. Among the five members of the PLK family, PLK1 is recognized to be the fundamental component for cell division to take place correctly, which makes PCM-075 such an attractive drug candidate.
PCM-075 is selective only for PLK1, has a short half-life of approximately 24- hours, and is oral (not IV) making it a potentially safer and more efficacious PLK inhibitor than a prior investigative pan-PLK inhibitor.
PCM-075 Clinical Development Plan
We believe PCM-075 has a clear clinical development path. We successfully completed the transfer of the active Investigational New Drug Application (IND) with the FDA from Nerviano Medical Sciences to Trovagene, in April, 2017. We plan to submit an IND application to the FDA Division of Hematology Products (DHP) for a Phase 1/2 trial in patients with AML in Q2, 2017. This trial will determine dosing of PCM-075 in patients with AML, provide a preliminary assessment of response, and explore the use of correlative biomarker analysis to select patients most likely to respond to treatment.
PCM-075 has demonstrated preclinical activity in other solid and hematologic cancers. We plan to explore additional indications going forward.