New Generation Therapeutic vaccine for the Treatment of HPV infections and Cervical Dysplasia

Project Information

CerviVax

Grant agreement ID: 698585

DOI

10.3030/698585

Project closed

EC signature date 18 August 2015

Start date 1 September 2015

End date 29 February 2016

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

VLP THE VACCINES COMPANY
Spain

Periodic Reporting for period 1 - CerviVax (New Generation Therapeutic vaccine for the Treatment of HPV infections and Cervical Dysplasia)

Reporting period: 2015-09-01 to 2016-02-29

Summary of the context and overall objectives of the project

VLPbio (www.vlpbio.com) is a biotechnological company applying immunotherapeutic solutions to fight and prevent human and animal diseases addressing unmet clinical needs in the main pharmaceutical markets. Our technology is based on patented and proprietary Ch-VLP platform (Chimeric Virus like Particles) derived from the Infectious Bursal Disease Virus (IBDV).

Our main product is Cervivax, an immunotherapeutic vaccine focused on the treatment of cervical dysplasia and infections caused by HPV-16 and HPV-18 (Human Papilloma Virus), which is responsible for most of the cases of cervical lesions detected all over the world. Although, there are prophylactic approaches to prevent viral infection, currently do not exist commercial therapeutic solutions to treat infections or lesions caused by the infection, other than surgery combined by chemotherapy. We position our product to cover this unmet need. We have an in vivo efficacy proof of concept of the product with excellent results, overpassing those of other therapies under development in terms of efficacy in absence of any adyuvant. The overall aim of the project is to bring CerviVax from the current status up to clinical-phase I, where we are aiming to license it to a large biotech or pharma company.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first SME phase, we wanted to study the feasibility of the project. To do this, we have validated the market, we have studied in detail the competence, we have elaborated a financial plan, completed a regulatory roadmap. In relation with IP, we have up-dated FTO of CerviVax patent portfolio and defined a strategy to maintain this situation and strength it. The result of this study has been satisfactory and it was used to develop a consolidated business plan.

Once the feasibility study completed, we are able to ensure that there is a large market opportunity for CerviVax: expected quota could represent over 1,5 million patients per year. Nowadays, there are no therapeutic solutions against HPV-related diseases in the market; all products are still in development phase. The high immunogenic potential of CerviVax allows us to be confident in the competitive advantage of this vaccine among the solutions currently under development.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The result of the feasibility study together with the interest shown by some pharmaceutical companies for our products, have determined that we continuing pursuing the project idea. We are looking for funding sources to achieve our goal, which included SME instrument phase II and other sources as venture capital.

CerviVax Project