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Latest news

Interim Analysis of Ignyta's Entrectinib Suggests Potential Best-in-Class Profile as a First-Line Targeted Therapy in Patients With ROS1-Positive...
San Diego, October 17th 2017 - Ignyta, Inc. - Interim Analysis of Ignyta's Entrectinib Suggests Potential Best-in-Class Profile as a First-Line Targeted Therapy in Patients With ROS1-Positive Non-Small Cell Lung Cancer
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FDA Grants Orphan Drug Designation to Trovagene's PLK1 Inhibitor, PCM-075, for the Treatment of Acute Myeloid Leukemia (AML)
San Diego, October 9th 2017 - Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) granted an orphan drug designation to PCM-075 for the treatment of patients with acute myeloid leukemia (AML) on September 28, 2017. PCM-075 is an oral, highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine Polo-like Kinase 1 (PLK1) enzyme, which appears to be over expressed in several different hematologic malignancies and solid tumor cancers."
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'Open Day Open Science', nel campus di Nerviano un evento dedicato agli studenti in occasione della Biotech Week

Nerviano, 19 Settembre  Nerviano Medical Sciences parteciperà alla prossima Biotech Week, la settimana di eventi e manifestazioni dedicati al settore delle biotecnologie, con un evento dedicato agli studenti delle scuole superiori. L'iniziativa ha l’obiettivo di celebrare il ruolo chiave di queste tecnologie e i successi della ricerca.

"E' un orgoglio essere parte di questa iniziativa mondiale, - ha commentato il Dr. Agazzi - che nel 2015 ha ottenuto la “Medaglia del Presidente della Repubblica” quale premio di rappresentanza e quest’anno gode del patrocinio del Senato della Repubblica. Per questa edizione abbiamo pensato di aprire le porte del Campus agli studenti per l'importanza che riconosciamo al mondo della Scuola e l'interesse e curiosità che da sempre I ragazzi riservano alla attività del Centro. Inoltre, - conclude Agazzi - siamo lieti e orgogliosi di partecipare a questa inziativa insieme a diversi partner istituzionali quali l'Associazione europea delle imprese biotech che l'ha lanciata una decina di anni fa in Canada, EuropaBio che l'ha importata nella Comunità Europea nel 2013 in occasione del 60° anniversario della scoperta della struttura DNA e Assobiotec che la coordina a livello nazionale."

Di seguito il programma completo della manifestazione.


ebw programma


Trovagene announces Manufacturing Agreement with NerPharMa for Supply of PCM-075 for AML Trial
San Diego, June 29th 2017 - Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced it has executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., in Milan, Italy, to manufacture drug product for PCM-075.
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Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration
San Diego, May 15th 2017 - Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib "for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies."
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Trovagene and Nerviano Announce License Agreement for therapeutic candidate PCM-075

Nerviano, Italy (March 15, San Diego, CA Trovagene, Inc. NASDAQ: TROV) - Trovagene, 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.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene's strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2016 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

 
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Nerviano Medical Sciences

Nerviano Medical SciencesHeart of the innovative Group focused on the identification of new therapeutic strategies, research and development of new drugs, shapes the future of the oncology.
www.nervianoms.com

Accelera

AcceleraAn Italian preclinical research Company, recognized and certified, all over the world provides high standard integrated services, with reliability and international compliance.
www.accelera.org

Clioss

CliossWith an extensive experience, Clioss partners worldwide Biopharma, Biotech and Research Institutions for full cycle drug development from First-Time-In-Man.

www.clioss.com

NerPharMa

NerpharmaConsolidated know-how, the highest quality standards characterize the offered services: for the formulation, the registration and the production of the active principle.
www.nerpharma.com

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