Date prepared: December 13, 2021, 10:06 PM<\/p>\n\n\n\n
Subject: Singing of an agreement on implementing and co-funding a commercial clinical trial project \u2013 development of innovative therapeutic solutions using RNA technology<\/p>\n\n\n\n
Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) \u2013 inside information.<\/p>\n\n\n\n
Content of the report:<\/p>\n\n\n\n
The Management Board of Celon Pharma S.A. (\u201cCompany\u201d, \u201cBeneficiary\u201d) hereby informs that on December 13, 2021 an agreement was signed between the Company and the Medical Research Agency (\u201cAgency\u201d) on implementing and co-funding a commercial clinical trial project \u2013 development of innovative therapeutic solutions using RNA technology, entitled: \u201cTransformRNA \u2013 mRNA Therapeutics generation platform\u201d (\u201cAgreement\u201d and \u201cProject\u201d or \u201cTransformRNA\u201d, respectively). Information that the aforementioned project was selected for co-funding has been announced by the Company in current report No. 48\/2021 on November 29, 2021.<\/p>\n\n\n\n
The Agreement determines the rules under which the Agency co-funds the Project and the rights and obligations of the parties related to the Project co-funded as a part of implementing measures dedicated to, among others, minimizing the epidemiological risk related to the spread of SARS-CoV-2 coronavirus.<\/p>\n\n\n\n
As part of the Project, the Beneficiary undertook to conduct industrial research, development works and to implement the Project; that includes conducting commercial clinical trials. The aim of TransformRNA is to use the RNA technology for development and production of vaccines and drugs that would be the answer to the challenges of modern medicine, i.e. preventing SARS-CoV-2, alfa-1 antitrypsin deficiency (AATD) in the area of lung diseases and cancers for which no effective therapeutic options are available (pancreatic cancer, ovarian cancer, breast cancer, prostate cancer), not only in terms of conventional therapeutic means, but also to develop cancer vaccines.<\/p>\n\n\n\n
Project implementation period: from September 1, 2021 to August 31, 2027.<\/p>\n\n\n\n
The total cost of the Project amounts to PLN 141.6 million and is equal to the total amount of eligible expenses. The Agency granted the Company co-funding in an amount not exceeding PLN 83.5 million, which constitutes 59% of total eligible expenses under the Project. Co-funding will be transferred in a form of an advance payment or a refund, made in tranches.<\/p>\n\n\n\n
The Company\u2019s Management Board points out that the first stage of the Project includes essential research intended to confirm and validate therapeutic objectives. In the next stages of preclinical work, mRNA-based medicines will be developed; their safety and efficacy will then be verified in phase I and II clinical trials. In addition, the Project will ensure the improvement and optimization of the existing manufacturing infrastructure, and selected investments (including the purchase of selected GMP and fill-and-finish line equipment) will allow the production of mRNA products on a scale sufficient for key clinical trials as well as first commercial batches.<\/p>\n\n\n\n
Economic rights to the results of scientific research or development works developed under the Project will belong to the Beneficiary.<\/p>\n\n\n\n
The Agreement contains a disclaimer stating that in case the researched medicinal product is developed, the State Treasury represented by the Agency will be authorized to purchase a number of doses of RNA vaccines allowing to complete 40 million full vaccination courses or a medicinal product other than a vaccine that is the subject of the Project at a fair price<\/p>\n\n\n\n
– not later than within 5 years after obtaining marketing authorization for the researched medicinal product. Upon the Agency’s request, the Beneficiary will be obliged to furnish infrastructure created under the Project against payment, for the production of a medicinal product used for fighting a disease that is a reason for the announcing a state of epidemic threat or a state of epidemic.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Management Board of Celon Pharma S.A. (\u201cCompany\u201d, \u201cBeneficiary\u201d) hereby informs that on December 13, 2021 an agreement was signed between the Company and the Medical Research Agency (\u201cAgency\u201d) on implementing and co-funding a commercial clinical trial project \u2013 development of innovative therapeutic solutions using RNA technology, entitled: \u201cTransformRNA \u2013 mRNA Therapeutics generation platform\u201d (\u201cAgreement\u201d and \u201cProject\u201d or \u201cTransformRNA\u201d, respectively). Information that the aforementioned project was selected for co-funding has been announced by the Company in current report No. 48\/2021 on November 29, 2021.<\/p>\n","protected":false},"author":20,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[46],"tags":[],"class_list":["post-22805","post","type-post","status-publish","format-standard","hentry","category-current-reports"],"acf":[],"yoast_head":"\n