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 commercialization 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 commercialized ECHO-7 virus that has been clinically used for cutaneous melanoma with trademark RIGVIR^®. The company holds also a complete set of international patents for the production and use of an ECHO-7 virus, including application for Uveal 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 the rare disease – Uveal Melanoma.

According to encouraging preliminary preclinical data and clinical cases, possibilities of commercialization should be elaborated, and its foundation processes started.

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

A number of investors will be attracted to cover the subsequent development costs, which based on initial estimates amounts to 10 Million EUR. After the commercialization 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 and clinical cases show convincing results for the efficiency of the medicine.

Depending on the results of the project, additional investors will be enrolled, and investment rounds will be initiated; the total investment is estimated to the amount of 10 million EUR.

As per 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 completed “freedom to operate” and all of the necessary patents.

There are clear market incentives also from the EMA regulatory, including market exclusivity and reduced fees.