Molecure to begin clinical development of novel dual arginase inhibitor OATD-02 for the treatment of cancer after gaining permission to conduct first clinical trial in Poland

• OATD-02 is an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer.
• Phase I clinical trial to begin later in 2022 to assess safety, tolerability and efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors.

WARSAW, Poland, Nov. 28, 2022 /PRNewswire/ -- Molecure S.A. ("Molecure")  (WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces today that the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products granted 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.

Dr Samson Fung, Chief Medical Officer, 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 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.

For further information, please contact:

Molecure S.A. (PR & IR)    
Marta Borkowska
Email: m.borkowska@molecure.com
(+48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)          

Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin
molecure@medistrava.com
+44 (0)203 928 6900

About Molecure

Molecure is a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate the function of underexplored protein and RNA targets to treat multiple incurable diseases.

Molecure has generated a diverse pipeline of eight distinct programs with the support of leading academic life science institutions.

Molecure's most advanced in-house drug candidate is OATD-01, a first in class dual chitinase inhibitor for the treatment of interstitial lung diseases, such as sarcoidosis and idiopathic pulmonary fibrosis, that is Phase II ready. A Phase II trial in patients with sarcoidosis is expected to start in 2023.

Our second proprietary candidate is OATD-02, an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, which is expected to advance to Phase I clinical development before the end of 2022.

Molecure's headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit molecure.com/en/

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