OncoArendi has received scientific advice from the European Medicines Agency (EMA) on the clinical development of OATD-02 and has signed an agreement with BIOMAPAS for the comprehensive organization of a Phase I clinical trial for the OATD-02 compound in patients with different types of cancer.

'We are very proud to introduce our next molecule into clinical trials. We have just received answers from the European Medicines Agency to questions about both the quality of preclinical data, which forms the basis for starting the first human trial (FIH), and the design of the planned clinical trial, asked as part of the scientific advice procedure. We have analyzed the documentation and assess that the direction of the answer is in line with our proposals and expectations. In other words, the EMA document does not raise any significant issues that would change the proposed Phase I clinical trial plan for the OATD-02 compound, i.e. it should not affect its schedule and budget , says Dr. Anna Bajera, Operational Director of Clinical Trials at OncoArendi Therapeutics S.A.

'The fiH (First In Human) study plan and design of our flagship OATD-02 program have been analyzed by the European Medicines Agency. We received recommendations on how to conduct Phase I clinical trial in the most effective way to help patients and minimize the risks arising from the first administration of the drug to a person. According to scientific advice, the presented data from preclinical studies support the application for fiH study in patients with solid tumors and leukemia who have exhausted the available therapeutic options. Both the proposed target patient population, recruitment criteria, study endpoints, as well as dosage issues were positively evaluated by EMA advisors. We also received valuable suggestions to implement in the clinical trial plan to optimally include and safely guide patients receiving our treatment. The company's priority is to include oncological patients in arginase inhibitor therapy as soon as possible and a positive opinion from the EMA brings us even closer to this - says Dr. Marta Dudek, Medical Director of OncoArendi Therapeutics.

On 7 February this year, OncoArendi Therapeutics concluded an agreement with the Lithuanian company BIOMAPAS for the comprehensive organization and conduct of a first phase clinical trial of the 'First in Human' type for the OATD-02 compound as part of the project 'Preclinical and clinical development of an arginase inhibitor for use in anticancer immunotherapy' co-financed by the EU. The value of the contract is approx. EUR 2.9 million, which is the equivalent of approx. PLN 13.2 million.

'The agreement signed today is an important milestone in the beginning clinical development of the OATD-02 compound. We plan to include the first patient in the study in the second half of 2022. The clinical trial itself will last from 18 to 24 months, but the preliminary results in the first groups of patients will be known already in the first half of 2023. We are glad that this key stage of the development of our most advanced project will be supervised and coordinated by experienced specialists in this area - Chief Medical Officer, Dr. Samson Fung, Medical Director, Dr. Marta Dudek and Clinical Research Operations Director, Dr. Anna Bajera - says Dr. Marcin Szumowski, President of the Management Board and shareholder of OncoArendi Therapeutics S.A.

BIOMAPAS was selected by OncoArendi in a competition procedure, the results of which were announced in November last year.

BIOMAPAS will be responsible for organizing a Phase I clinical trial for OATD-02, which will involve up to 40 patients. The clinical trial will be conducted in 3-4 centers in the Polish. Those centres shall be medical entities or specialised early phase clinical trial centres which shall have access to patients, adequate experience, staff and facilities necessary to conduct the clinical trial in question.

OATD-02 is the first in its class and the only dual arginase inhibitor (both ARG1 and ARG2) developed on the market as a potential innovative drug for the treatment of patients with selected forms of advanced cancer. OATD-02 has the potential to unlock the overall immune response in the fight against cancer, as well as strong action inside cancer cells - in the tumor microenvironment. The aim of the clinical trial, during which the compound OTAD-02 will be administered to a human for the first time (the 'First in Human' study), will be to investigate the safety, tolerability and antitumor activity of OATD-02 in patients of both sexes with cancer. This will be a Phase I clinical trial, with increasing doses of the compound administered.

OncoArendi is a clinical-stage drug discovery and delivery biotechnology company that uses its own unique expertise in medical chemistry to seek out and develop best-in-class small-molecule drugs that directly modulate RNA and protein targets in the treatment of many incurable diseases.

OncoArendi's world-class medical chemistry technologies have enabled it to generate a diverse portfolio and nine distinct programs with the support of leading academic scientific institutions around the world, including the International Institute of Molecular and Cell Biology in Warsaw (MIBMiK), which has significant experience in studying the structure and function of RNA.

OncoArendi has entered into an exclusive cooperation and license agreement with Galapagos for the global development and commercialization of OncoArendi's OATD-01. OATD-01 is a Phase 2 ready inhibitor of mammalian chitotriosidase/acid chitinase (CHIT1/AMCase) for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrosis-related diseases.

OncoArendi's headquarters and laboratories are located in Warsaw and ?od?, and the Company is listed on the Warsaw Stock Exchange (ticker: OAT).

Detailed information can be found on the LinkedIn https://oncoarendi.com/en/ pages: @OncoArendi Therapeutics | Twitter: @oncoarendi | YouTube: @OncoArendi Therapeutics

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