Molecure S.A. says the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has given the company permission to conduct the first clinical trial of OATD-02.
The planned phase I trial will be an open-label, multi-center, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study will be conducted in Poland and will enroll a maximum of 40 patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma. The study is expected to start before the end of 2022.
Samson Fung, chief medical officer at Molecure, said: “We are delighted to receive approval to advance OATD-02 into its first clinical study which is a major milestone for Molecure. OATD-02 is the only dual acting arginase inhibitor in development globally for the treatment of cancer and it has demonstrated significant anti-cancer activity in pre-clinical studies, by impacting both tumor immunity and tumor metabolism.
“OATD-02 is the second candidate from Molecure’s pipeline to enter the clinic and we look forward to seeing the first data from patients with solid tumors where despite the availability of new treatments there is still a significant unmet need.”
The clinical trial will be co-financed by the European Union within the framework of the European Funds Smart Growth and European Regional Development Fund.
About Molecure’s OATD-02
OATD-02 is being developed as a potential new therapeutic for a range of solid tumors. It is the first and only dual acting, highly potent arginase inhibitor in development for the treatment of cancer, involved in both tumor immunity and metabolism.
Arginase 1 (ARG1) and arginase 2 (ARG2) are validated targets that have been found on a variety of tumor types where their increased activity correlates with more advanced disease and worse clinical prognosis due to diminished arginine levels.