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Celon Pharma has secured a contract with the Medical Research Agency for the execution and finance of a commercial clinical trial project called “TransformRNA – mRNA Therapeutics generation platform” to create breakthrough therapeutic solutions using RNA technology. The project’s overall cost is PLN 141.6 million, with co-financing totaling approximately PLN 83.5m.
As part of the project, Celon Pharma undertook to carry out industrial research, development works and implementation of the project, which includes conducting commercial clinical trials. The goal of TransformRNA is to use mRNA technology to develop and produce vaccines and therapeutics in response to the challenges of modern medicine, i.e. SARS-CoV-2 prevention, alpha 1-antitrypsin (AATD) deficiencies in the area of lung diseases, and neoplasms without an effective therapeutic option (pancreatic cancer, ovarian cancer, breast cancer, prostate cancer), not only in conventional therapeutic terms, but also in the development of anti-cancer vaccines. The project implementation period is from 1 September 2021 to 31 August 2027.
The contract lays out the rules for the Agency’s co-financing of the project’s implementation, as well as the parties’ rights and obligations in relation to the project’s implementation. The project was financed as part of activities aimed at, among other things, reducing the epidemiological threat associated with the spread of the SARS-CoV-2 coronavirus. The project’s overall cost is PLN 141.6m, which is equivalent to the whole amount of qualifying costs. The agency authorized the firm co-financing in the amount of PLN 83.5m, which is 59% of the total project cost eligible for support. Co-financing will be provided in the form of a lump sum payment or a series of payments.
The agreement also contains a provision that, in the event that an investigational medicinal product is developed under the project, the State Treasury, represented by the Agency, will be entitled to purchase a reasonable number of doses of RNA-based vaccines allowing for 40 million complete vaccination cycles or a medicinal product other than the vaccine under the project – not later than 5 years after obtaining the marketing authorization for the investigational medicinal product.
The beneficiary will be required to lend the infrastructure produced under the project for a charge to the Agency in exchange for the creation of a medical product to battle the disease entity that has caused the announcement of an epidemic threat or state, it was also said.