The aim of the entire Project (Phase I and II) is to develop and implement into Ryvu Therapeutics' own operations a candidate for a new generation oncological drug, characterized at the level of Phase I clinical trials and being a targeted therapy based on the phenomenon of synthetic lethality. R&D works are focused on the development of MTA - a co-operative inhibitor of the PRMT5 methylsom protein complex, allowing the development of pharmacotherapy in one of the largest genetically defined populations of oncological patients with MTAP gene deletion, constituting approx. 15% of all cancer cases. Deletion of the 9p21 lokus, containing the p16/CDKN2A tumor suppressor gene, is one of the most common genetic changes found in human tumors, the prevalence of which is only equal to that of cMYC amplification. One of the genes found in lokus 9p21 and most commonly co-opted from p16 is the methylthioadenosine phosphorylase (MTAP) encoding gene. It is the only metabolic enzyme responsible for the breakdown of methylthioadenosine (MTA), a metabolite that is a byproduct of the polyamine synthesis pathway. MTAP deletion results in massive accumulation of MTA in cells. Although excess MTA is partly secreted by cancer cells, its continuous production also causes intracellular accumulation. MTA, at high concentrations, is a very selective inhibitor of PRMT5 methyltransferase, competitive to the substrate: S-adenosylmethionine (SAM). The accumulation of MTA in cells with MTAP deletion results in a partial inhibition of PRMT5 methylation activity, which results in a decrease in the level of symmetric dimethylation of arginine of the entire proteom, and thus increased sensitivity of cells to modulation of methylsom activity. The division into Phases I and II is carried out between the initially planned Phases/Tasks of the Project, enabling its substantive continuation while maintaining the separateness and financial independence of the phases. In Phase I (Stage/Tasks 1 and 2) advanced research was carried out to discover a new molecule with therapeutic potential. As a result, a project-compliant preclinical candidate was developed, which was validated in biochemical tests, cellular and animal models. The compound has a favourable safety pharmacology profile and is protected by a global patent application. In Phase II (Stage/Tasks 3 and 4), for the preclinical candidate selected in Phase I, it is planned to perform a package of preclinical tests, the so-called IND/IMPD package. Investigational New Drug) and conducting a Phase I clinical trial. (1) Activity 3: Preclinical tests of the IND/IMPD package, due to the degree of difficulty, precision, specificity and correctness of performance in accordance with the GLP/GMP standard, will be conducted by the Ryvu research team and specialized entities of the so-called preclinical Contract Research Organization (CRO) under the direct supervision of the Company. The IND/IMPD package will include an initial assessment of the safety and efficacy of the potential drug before it is used in humans and is an essential part of the application for authorisation to start clinical trials. (2) Task 4: After obtaining the consent of the Regulatory Agency, i.e. The European Medicines Agency (EMA) or the Food and Drug Administration (FDA) and local Ethics Committees will register the clinical trial. Ryvu scientists will be responsible for the overall implementation of the development work according to the research plan, protocol and regulations. Their tasks will include monitoring results from all areas and performing integrated analysis. The test will be performed by authorized, specialized CRO entities. Phases I and II are complementary and form one coherent project reflecting the successive stages of discovery and development of an innovative candidate for an oncological drug. The division made does not affect the achievement of the original objectives of the entire Project. Details - Annex Criterion 2.