Notovir srls

image_startup_Notovir srls

Startup name: Notovir srls
Registered Office: Italy, Novara
Established in: 27/12/2017
Startup Category: Health
Financing round: yes
Working prototype: yes
Competitions/Prizes won: yes (StartCup Piemonte 2018)
Founders: Marco De Andrea, Santo Landolfo, Marisa Gariglio



Notovir srls

NoToVir is a new biotech Start-up – academic Spin-off, established on December 2017, active in the field of biology and medical biotechnology. NoToVir Srls arises from the experience and work carried out over the years by the Laboratory of Pathogenesis of Viral Infections (VIPLab) – Department of Public Health and Pediatric (DSSPP), University of Turin (UniTo), in collaboration with the Laboratory of Virology, Department of Translational Medicine (DiMET), University of Eastern Piedmont (UPO), Novara. The company’s main objective is the screening of innovative antiviral molecules for the production of new pharmacologically selectively active principles against viral infections.
The added value of NoToVir towards the life sciences and risk investors markets is represented by the development prospects of a new compound along a pre-revenue stage. Moreover, the team has a long term experience in the field of transfer and exploitation of knowledge at the market, and thanks to the technological value of the NoToVir biological approach, unique and absolutely innovative, the company has already a multiple pipeline of development of various lines of compounds, to be used for the setup of new treatments against different viral infections.
The current development lines are related to Herpesvirus infections, and in particular on the treatment of congenital cytomegalovirus (cHCMV) infections or cytomegalovirus infections in transplanted immunosuppressed individuals. Conditions whose state of the art therapy and available treatments are still largely unsatisfied, considering the wide prevalence of pathologies and the significant side effects of non-specific and off-label experimental drugs in use.
The first two patents (an internationaI PCT extension and a national one to be registered soon) rely on a new mechanisms of action against Herpesvirus, addressed to block the chemical modifications (biosynthesis) of the proteins that these viruses require to regulate their replication. It is important to consider that no drugs have been developed so far that block post-translational modifications (PTM) specifically activated by any virus, and therefore the proposed approach is absolutely novel and can be developed over a wide range of development pipelines.
In detail, the proponent team highlighted for the first time the role of a specific PTM, known as citrullination (i.e. the non-physiological transformation of the arginine contained in cellular proteins into citrulline, driven by cellular enzymes belonging to the peptidyl arginine deiminase (PAD) family) during viral infections.
The NoToVir team involves scientists with different expertise and highly translational aptitude, with significant results in the study of viral replication, immune response to infections and the study of DNA viruses (herpesviruses, papillomaviruses and polyomaviruses) in animal models, as well as an Advisory Board and partners of international reputation including, among others, the Director of the Neonatology Clinics of the S. Anna Hospital of Turin (Italy), the head of the Department of Biochemistry and Pharmacology of the University of Massachusetts (USA) and a Full Professor of Immunology and Immunopathology of the Department of Medicine Molecular – “La Sapienza” University of Rome (Italy).
As a business model NoToVir will internally run the development phases described in the Strategic-operational Plan, at least until the conclusion of the pre-clinical phase, operating in the form of a dedicated biotech research firm.
As for the target market, the congenital HCMV infection is the most common congenital infection worldwide, with an estimated incidence in developed countries ranging from 0.6 to 0.7% of all live births, resulting in about 60,000 newborns each year with congenital HCMV infection in the western world. Since the incidence of congenital HCMV infection matches with maternal seroprevalence, the estimated incidence in developing countries is even higher, between 1 and 5% of all live births.
The following estimates refer to the ReportLinker© (2013) and Global Information© (2018) surveys: the global HCMV infection market, including the United States, United Kingdom, France, Germany, Italy, Spain and Japan markets, is worth about USD 700M, with a growth trend towards about USD 1.12B by 2022 (compound annual growth rate – CAGR of 6.29%).
In light of these data, a global overview of the current market value of drugs used for the therapy of HCMV infections can be drawn, as detailed in the recently published report “Cytomegalovirus (CMV) Infections – Pipeline Assessment and Market Forecasts to 2019 “(GlobalData, 2013). The prophylactic market for HCMV was estimated at USD 450M in 2013, with a growth expected to USD 750M in 2022 (CAGR of 7.79%). The HCMV therapeutic market was estimated at about USD 300M million in 2013 and is expected to grow (CAGR of 3.51%) to reach USD 350M in 2022.
Five competitor drugs have been licensed so far for the treatment of HCMV infections: Citovirax® and Valcyte® (owner: Roche), whose intravenous administration is the only therapeutic treatment currently in use for infected newborns, although their high toxicity demonstrated by potentially carcinogenic, teratogenic and mutagenic actions; Foscavir® (owner: Clinigen Healthcare), Vistide® (holder: Gilead) and Fomivirsen® (holder: Novartis).
Robust preliminary data suggest that NoToVir compounds are dramatically less toxic. Moreover, they cannot induce resistance to therapy since they are not directed against the viral genome.
The strategic and operational plan is based on the development of a distinct biotechnological business line: this entail the involvement of various resources at different levels, in order to maximize the operational efficiency of the team; all the resources and purposes are preliminarily identified and organized and the milestones defined for each activity, in order to increase the value of the company in an already widely described round-financing logic. The phases successfully completed in the R&D by the proposing academic team (and included as company assets) are described below.
The start-up aims to promote and spread its social character, also according to the dictates of the planned actions of the “Social Innovation Europe”, with an innovation that will lead to an increase in solidarity and welfare exchanges between people.
To complete the pre-clinical development of the highly selective NotoVir compounds, including a GCP quality system and cGMP Industry aimed to the investigative phase of the trials, a first funding of 1.5M€ is required to support the next 24 months of activity for: R&D (consumables and highly qualified, technical and managerial human resources); technical outsourcing; marketing, dissemination and technological transfer; IPR strategy and preservation (patents and trademarks).
The Exit Strategy is similar to those followed by other Pharma&Biotech start-ups, since the current phase does not allow a reliable pre-money valuation for a potential investment. Preliminary contacts have been established with potential industrial buyers, with whom a purchase in equity is expected and the guarantee to collaborate for the continuous and constant development of the different project lines in the NotoVir pipeline. There are no comparable Exit cases for companies operating in this specific target.

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