INSTRUMENT: POR FESR Sardegna 2014 – 2020 Asse 1 Azione 1.1.3 

CALL: Aiuti per Progetti di Ricerca e Sviluppo

TITLE: Sviluppo di farmaci innovativi contro retrovirus endogeni, virus esogeni e tumori con particolare rilevanza nella Regione Sardegna

Development of innovative drugs against endogenous retroviruses, exogenous viruses, and tumors with particular relevance to the Sardinia region

Obiettivo Principale / Main Goal: Innovazione delle Imprese / Innovation of Enterprises

Descrizione / Description

Il progetto che coinvolgeva l’azienda ViroStatics e l’Università di Cagliari – Dipartimento di Scienze della Vita e dell’Ambiente – ha permesso l’identificazione di composti inibitori delle chinasi ciclina-dipendenti (CDK) con un buon profilo di tossicità e attivi contro diverse linee tumorali, in vitro e in vivo, rappresentative di alcune patologie rilevanti per la Regione Sardegna e non solo, quali la leucemia, il mesotelioma, il tumore al seno. Sono stati raccolti dati fondamentali per avanzare lo sviluppo preclinico del candidato clinico VS2-370 attraverso studi di tossicologia animale e farmacocinetica, avvicinando il composto all’entrata nelle fasi cliniche di sviluppo. Il progetto si è inoltre occupato dello studio di composti efficaci contro virus esogeni (HBV, HPV), del ruolo dei retrovirus endogeni umani nella sclerosi multipla e della valutazione degli inibitori di CDK nell’interferire con l’espressione di tali virus per giungere ad un trattamento alternativo per questa malattia.

The project involving ViroStatics and the University of Cagliari – Department of Life and Environmental Sciences – has enabled the identification of cyclin-dependent kinase (CDK) inhibitor compounds with a good toxicity profile and activity against various tumor cell lines, both in vitro and in vivo. These cell lines represent relevant pathologies not only for Sardinia,  including leukemia, mesothelioma, and breast cancer. Essential data has been collected to advance the preclinical development of the clinical candidate VS2-370 through animal toxicology and pharmacokinetic studies, bringing the compound closer to entering clinical development phases. Additionally, the project has investigated effective compounds against exogenous viruses (HBV, HPV), the role of human endogenous retroviruses in multiple sclerosis, and the evaluation of CDK inhibitors in interfering with the expression of these viruses to reach an alternative treatment for this disease.

Codice Progetto / Project Code: RICERCA_1C-6

CUP: G87H18000020006

Importo Totale Progetto / Total Project Amount: Euro 438.100,00

Importo Finanziato / Financed Project: Euro 262.537,50

Fonte / Source: POR FESR Sardegna 2014-2020

Data Inizio / Start Date: 28/07/2017

Data Fine / End Date: 31/12/2020

Contact / Contatto: d.deforni@virostatics.com

Sardegna Programmazione

INSTRUMENT: POR-FESR 2014-2020 – Call: Programma di ricerca e sviluppo per l’integrazione della filiera BIOMED

Project: INCITE

TITLE: INibitori di CDK Innovativi per il Tumore al pancrEas (INCITE) – Innovative CDK Inhibitors for the Treatment of Pancreatic Cancer 

Pancreatic cancer has not yet an adequate treatment and is rated among the most aggressive cancers, with 26.611 new cases in Europe every year, ranking as the 7th leading cause of cancer death in both sexes (over 74% of patients do not survive at 1 year since diagnosis and 95% dies within 5 years).CDK4/6 is an important and actionable target in pancreatic cancer. Furthermore, CDK9 represents a good target in pancreatic cancer as its inhibition can synergize with DNA damaging agents.

ViroStatics established a collaboration with the leading center of the University of Verona, Italy (AOUI, led by prof. Tortora and colleagues), bearing more than 40 years’ experience in the field of pancreatic diseases. Our colleagues have established that ViroStatics’ lead candidate VS2-370 is potent against cell lines from pancreatic cancer, more potent than other drugs currently approved for the treatment of pancreatic cancer or in advanced stage of development. VS2-370 could be used in combination with paclitaxel, GDC0068, LY2090314, SN-38, all treatment options in this setting with which VS2-370 showed synergistic activity in inhibiting tumour growth.

This project successfully concluded in April 2019.

INSTRUMENT: POR FESR 2014-2020 “Innovation Services” – Project CUP G83D1600010002

TITLE: Servizi per l’Innovazione

This project aimed at characterizing the mechanism of action of ViroStatics’ library of compounds with mainly proteomics analysis. These studies have been implemented in collaboration with Porto Conte Ricerche.

Project timeline: Jan 2016-Sep 2016

INSTRUMENT: H2020-SMEInst-2016-2017 – Project “THUNDER”

TITLE: Development of the Cyclin-Dependent Kinase Inhibitor VS2-370 to Target HIV-associated Malignancies and to Purge Viral Reservoir.

This project, successfully concluded in July 2017, constituted the feasibility study for the present Phase 2 application.

INSTRUMENT: FP7-HEALTH-2013-INNOVATION – Project “THINPAD”

(http://www.thinpad.unisi.it/project/)

TITLE: Targeting the HIV-1 Nucleocpsid Protein to fight Antiretroviral Drug Resistance

The goal of the THINPAD project was to discover and develop novel anti-HIV agents targeting the HIV nucleocapsid protein, which is one of the most conserved sequence within HIV  strains and is highly required for HIV replication, being therefore a primary target to overcome antiretroviral drug-resistance.

ViroStatics was one of the 5 partners in the consortium and was supporting the in vitro evaluation of the cytotoxicity profile of the molecules and contributed together with the other SME driving the discovery phase and pre-clinical investigation, favouring the translation of results into innovative applications for health.

Project timeline: Sept 2013-Aug 2016

INSTRUMENT: Contratto di Programma – Project Consorzio Prokemia/ViroStatics

TITLE: Completamento dello sviluppo di un farmaco anti HIV/AIDS

This project aimed at the development of CDK inhibitors (discovery and early preclinical development). During this project ViroStatics has conducted a screening on CDK inhibitors family and was able to identify VS2-370 as lead compound, advancing its preclinical development and performing initial in vitro and in vivo studies.

Project timeline: Jan 2007-Jan 2016

INSTRUMENT: POR FESR 2007-2013 – Project CUP E15G13000050007 

TITLE: Progettazione e Studio di Composti “AV-HALT”, Una Nuova Classe di Farmaci con Doppia Attività Antivirale e Immunoprotettrice

During this project we have applied system biology analysis (proteomics and genomics) to ViroStatics’ library of compounds. This has helped elucidating the mechanism of action of the compounds. This work has been performed in collaboration with Porto Conte Ricerche, one of the motors of the Science and Technology Park of Sardinia, active in complementary areas of technology: biomarker discovery, diagnostic systems and biotechnologies applied to nutrition and health.

Project timeline: June 2012-Oct 2014