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Oncology: Trovagene and Nerviano Announce License Agreement for therapeutic candidate PCM-075

Trovagene, Inc., a precision medicine biotechnology company, and Nerviano Medical Sciences, S.r.l., a leading oncology discovery organization, today announced that they have signed a license agreement that grants Trovagene exclusive global development and commercialization rights to NMS-1286937, which Trovagene refers to as PCM-075.

PCM-075 is an oral, investigative drug and a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1). “We are excited to license PCM-075 and look forward to beginning a development program in patients with acute myeloid leukemia (AML),” said Bill Welch, CEO of Trovagene. “This transaction allows Trovagene to execute on our strategy to vertically integrate our ctDNA Precision Cancer Monitoring® (PCM) technology with precision cancer therapeutics by developing drugs where our deep understanding of tumor genomics may allow for effective targeting of appropriate cancer patients.” “We are very pleased to start a collaboration with Trovagene, a world leader in precision medicine,” said Andrea Agazzi, President of the NMS Group.

“Both Nerviano and Trovagene share the common goal of developing innovative new drugs for cancer patients. We're proud of this new important agreement as a further confirmation of our commitment to develop high level innovation through partnering. Our continuously increasing track record involves, in fact, companies at a worldwide level like Trovagene.” Under the terms of the license agreement, Trovagene will assume sole responsibility for global development and commercialization of PCM-075. Nerviano will receive an upfront payment of $2.0 million, as well as development and regulatory-based milestone payments and royalty payments on future net sales of PCM-075. Nerviano is the current manufacturer for bulk and finished drug for PCM-075 and Trovagene has all rights to manufacture bulk and finished goods. PLK1 is over-expressed in several different tumor types, including breast, prostate, ovarian, lung, gastric and colon cancers, as well as hematological malignancies.

A phase 1 safety study of PCM-075 was successfully completed in patients with advanced metastatic disease. Trovagene plans to develop PCM-075 initially in AML, where both Trovagene and Nerviano believe PCM-075’s target selectivity for PLK1, along with its oral availability, and shorter half-life as compared to other polo-like-kinase inhibitors, may be advantageous features of the drug. Trovagene has significant experience and expertise with biomarkers and technology in cancer, including AML. Trovagene is the patent holder of NPM1 for diagnosis and monitoring of patients. NPM1-mutated AML is a founder genetic marker in leukemia and accounts for approximately one-third of all AML patients. Trovagene will use its PCM technology to profile other dominant AML markers, such as FLT3, DNMT3A, NRAS, and KIT, to identify and measure patient therapy response.

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