Trovagene has executed a supplier agreement with NerPharMa, to manufacture drug product for PCM-075. The agreement covers the clinical and commercial supply of PCM-075 for Trovagene, and includes both Active Pharmaceutical Ingredients (API) and GMP (Good Manufacturing Process) production of capsules.
NerPharMa has previously supplied drug product for PCM-075 in a completed phase 1 study conducted by Nerviano Medical Sciences. NerPharMa has an established manufacturing process scaled for producing PCM-075 for future clinical studies and commercial use. Under the terms of the agreement, Trovagene directs NerPharMa to produce GMP-grade PCM-075 drug substance for use in Trovagene's Phase 1b/2 clinical program and for other related clinical and commercial activities. Trovagene is developing PCM-075, a polo-like kinase 1 (PLK1) inhibitor, and plans to initiate a Phase 1b/2 clinical trial in patients with acute myeloid leukemia (AML).
"This contract represents a significant step forward for the development of PCM-075," said Bill Welch, Chief Executive Officer of Trovagene. "We are excited to have a manufacturer of NerPharMa's caliber and experience producing GMP supply of PCM-075 bulk product and finished capsules. The availability of validated API and the ability to immediately initiate capsule production enables a cost-effective and accelerated start-up of our Phase 1b/2 clinical program."
NerPharMa's GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA) for the production of PCM-075.
"We are pleased to be working with Trovagene to manufacture and provide finished product for their investigational and commercial needs," said Angelo Colombo, CEO of NerPharMa.
PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in several different hematologic malignancies, as well as solid tumors such as breast, prostate, ovarian, lung, gastric and colon cancers. PCM-075 is orally bioavailable and has been explored in an initial Phase 1, open-label, dose-escalation safety study in patients with advanced metastatic solid tumor cancers. In this study, PCM-075 demonstrated an acceptable safety profile, as well as anti-tumor activity. Trovagene plans to initiate clinical trials of PCM-075 in AML, since it has significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life.