Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer

Molecure announces first patient dosed in Phase I trial with novel, first–in–class dual arginase inhibitor OATD-02 for the treatment of cancer

• OATD-02 is an oral, potent and selective dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer
• Phase I clinical trial to assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors – initial clinical data expected at the end of 2023
• Second new drug candidate from Molecure’s proprietary pipeline in clinical development

Warsaw, Poland 8 March 2023 – Molecure S.A. (“Molecure”: WSE: MOC) 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 unexplored protein and RNA targets to treat multiple incurable diseases, announces today that the first patient has been dosed in a Phase I trial evaluating OATD-02 as a monotherapy in cancer patients with advanced solid tumors.

The Phase I trial is an open-label, multi-center, first in human, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study is being conducted at three sites 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.

Marcin Szumowski, Chief Executive Officer of Molecure, said, “We are very excited to start this first in human clinical trial with OATD-02, the second candidate from Molecure’s proprietary pipeline to enter clinical development. This is another important milestone for the company and underpins our commitment to deliver novel medicines that can provide significant benefit to people suffering from advanced and/or metastatic solid tumors. We believe OATD-02 has shown a very promising pre-clinical profile, and we look forward to seeing the initial data from this first in human study in the latter part of 2023.”

Dr Samson Fung, Chief Medical Officer added: “OATD-02 is the first and only dual acting arginase inhibitor in development globally to treat solid tumors. This novel drug candidate has been designed to improve treatment outcomes, including in more advanced disease, helping to restore the patient’s antitumor immune response by overcoming the immunosuppressive tumor environment. The important data emerging from this trial will help to guide future clinical development for OATD-02, which we hope will bring treatment benefits to patients with a broad range of tumors.”

ENDS

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, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

About OATD-02

OATD-02 is being developed by Molecure 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.

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 seven 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 advanced to Phase I clinical development in Q1 2023.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/

LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA

Attachments

• Marcin Szumowski
• Samson Fung
• OATD-02