RIGVIR Holding introduces investment possibility

RIGVIR Holding introduces an A series investment opportunity to develop a new Oncolytic Virotherapy treatment for a rare disease.

During the 18-month project, it is planned to build a foundation for the execution of clinical trials and commercialisation of the product with a new trademark for the orphan disease – uveal melanoma.

Uveal melanoma is a rare disease. After brachytherapy, about half of the patients develop metastases; among those patients, the 1-year survival is reported to be 15%. Although there are clear incentives from the European Medicines Agency (EMA), including market exclusivity and reduced fees, so far there is no standard treatment available.

The company is the manufacturer of a marketal ECHO-7 virus that has been clinically used for cutaneous melanoma with the trademark RIGVIR®. The company also holds a complete set of international patents for the production and use of an ECHO-7 virus, including application for UVEA Melanoma. According to initial EMA/CHMP Scientific Advice – the available data are sufficient to enter clinical Phase II (e.g. a proof-of-concept study). Therefore the company intends to create a spin-off for the development of a therapeutic agent for a rare disease – uveal melanoma.

Prelimug preclinical data are encouraging. To this end commercialisation foundation should be elaborated and started.

The total project budget amounts to 1.4 Million EUR that will be used to execute an feasibility study, form the corporate spin-off and form the team. During the feasibility study, the company would finalise the preclinical studies and clinical case reports. The EMA scientific/regulatory advice will be received, and the clinical trial protocol will be validated.

A series will be attracted to cover the subsequent development costs, which based on initial estimates amounts to EUR 10 Million. After the commercialisation of the medicine, the company will either be sold or licensed to existing market players with an established network and a focus on rare diseases.

Summary:

  • The existing preclinical studies encourages results for the efficacy of the medicine.
  • Depending on the results of the project, additional investors will be enrolled, and investment rounds initiated; the total investment is estimated to the amount of EUR 10 million.
  • As per a EMA/CHMP Scientific Advice – the available data is sufficient to enter the clinical Phase II (e.g. a proof-of-concept study).
  • The company has complete “freedom to operate” and all of the necessary patents to successfully operate in the market;
  • There are clear market incentives also from the EMA regulations, including market exclusivity and reduced fees.

If you are interested in cooperation and investment, please contact us by e-mail: development@rigvir.com.