Molecure reports continued pipeline momentum for 6 months ended 30th June 2022

  • Our new name “Molecure” reflects expansion of scope of small molecule targets from novel proteins to mRNA in discovery & development of breakthrough therapies for multiple diseases
  • Worldwide rights regained to novel, dual chitinase inhibitor OATD-01 following a strategic review by Galapagos enabling first administration to sarcoidosis patients in a Phase II PoC study in mid-2023
  • Dr Samson Fung appointed as Chief Medical Officer to lead global clinical development, translational science and regulatory strategies
  • Strong progress across proprietary pipeline with two key clinical trials planned with OATD-01 and OATD-02 respectively
  • First administration of OATD-02 to oncology patients expected at end of 2022

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Molecure announces filing of Clinical Trial Application with Polish regulator for OATD-02, a novel dual arginase inhibitor being developed for the treatment of cancer

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

 

Warsaw, Poland  11 August 2022 – 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 RNA and unexplored protein targets to treat multiple incurable diseases, announces today it has filed a Clinical Trial Application (CTA) for OATD-02 with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The Company plans to conduct a Phase I clinical trial with OATD-02 in patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.

The Phase I trial is expected to 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 is expected to start in the fourth quarter of 2022, subject to regulatory approval.

Marcin Szumowski, Molecure CEO commented, “Today’s CTA filing represents a significant milestone in the development of OATD-02, potentially the first dual arginase inhibitor to enter the clinic. We have already seen promising pre-clinical data that shows OATD-02 has significant anti-cancer activity with potential to improve treatment outcomes in a broad range of solid tumors. Subject to regulatory approval we look forward to advancing OATD-02 into clinical development later this year.”

The clinical part of the development of the OATD-02 compound is carried out within the framework of the project: pre-clinical and clinical development of arginase inhibitor for application in anti-cancer immunotherapy (POIR.01.01.01-00-0415/17), cofinanced by the European Union in the framework of European Funds Smart Growth and European Regional Development Fund.

About OATD-02 (oncology)

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)                                      

Magdalena Licka

Email: m.licka@molecure.com

(+48) 512 777 001

 

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 RNA and underexplored protein 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 globally, including the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

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 in the second half 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/

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

Molecure to regain worldwide rights to dual chitinase inhibitor OATD-01

  • Follows an ongoing strategic portfolio review by partner Galapagos
  • Molecure to regain all rights, associated data, IP and inventory to OATD-01
  • Evaluating potential first indication and development plan for the asset in sarcoidosis

Warsaw, Poland  June 23, 2022 – 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 RNA and unexplored protein targets to treat multiple incurable diseases, announces today that it has regained full rights to its dual chitinase inhibitor OATD-01 together with all the related IP and know-how, full drug substance and drug product inventory. This is the result of an ongoing corporate strategy and portfolio review by its partner Galapagos NV.

Marcin Szumowski, Molecure CEO commented “We have enjoyed a very productive relationship with Galapagos and are pleased that we have been able to regain rights to OATD-01, which we believe holds great promise in several respiratory indications. Data generated to date reveal an attractive benefit-risk profile for this asset, and we look forward to revising our clinical strategy for the further development and subsequent partnering of this program in the near future”.

Andre Hoekema, Ph.D., Chief Business Officer of Galapagos added “We are grateful to have had the opportunity to partner with Molecure and to work on OATD-01. However, as part of an ongoing strategic exercise to renew and accelerate our portfolio, we decided to return all rights to OATD-01 to Molecure, with the confidence that they will progress this promising asset through the next stages of development.”

The return of OATD-01 and associated chitinase inhibitor programs provides Molecure with a renewed opportunity to generate value for its shareholders.

Once the internal assessment of data, reports and information received from Galapagos is completed, Molecure considers to initially develop OATD-01 in sarcoidosis, its preferred and originally selected indication. The company will seek the optimum path forward in this indication, with the intention to conduct a Phase II proof-of-concept (PoC) study. This will likely be an international study recruiting patients in the United States and Europe, including Poland.

Molecure has regained (at no cost) the full and exclusive rights to the results of all research, pre-clinical and clinical development performed by Galapagos with OATD-01 over the course of the last 18 months. The non-refundable Eur27 million received by Molecure in November 2020 as part of the original licensing deal and right of first negotiation of other molecules from its chitinase platform could support this important Phase II clinical study.

Molecure believes that the studies performed by Galapagos together with the scientific advice received from the EMA are highly supportive of further progressing OATD-01 into phase II clinical trials in the near term.

Molecure is confident that a positive result from the planned Phase II PoC study in sarcoidosis patients would open the possibility for the company to partner OATD-01 and its chitinase inhibitor IP for the second time.

Molecure is committed to solving unmet medical needs of patients with interstitial lung diseases, inflammation driven fibrosis and cancer. The Company looks forward to further informing investors on the next steps in the planned clinical development for OATD-01 in the coming weeks.

Dr Samson Fung, Molecure CMO, commented “Sarcoidosis is a systemic disease of unknown cause that is characterized by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system. Sarcoidosis is a global disease, affecting both men and women with a prevalence of about 5–50 in 100 000, with 70% of the patients aged between 25 and 45 years. The most severe and frequent complication of sarcoidosis is the occurrence of pulmonary fibrosis. This is usually associated with significant impairment of pulmonary function. Pulmonary fibrosis results in the majority of deaths related to sarcoidosis in western countries. There is currently no cure for sarcoidosis and treatments only modify the granulomatous process and its clinical consequences. During preclinical development, OATD-01 has been shown to significantly decrease the disease burden in the lungs of treated animals. In patients, the over-expression of CHIT1, the target of OATD-01 is both a marker of severity and disease progression.”

 

For further information, please contact:

Molecure S.A. (PR & IR)                                               

Magdalena Licka

Email: m.licka@molecure.com

(+48) 512 777 001

 

MEDiSTRAVA Consulting (Financial PR)                                  

Frazer Hall, David Dible, Sandi Greenwood. Eleanor Perkin

Email: molecure@medistrava.com

 

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 RNA and underexplored protein 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 globally, including the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

Molecure’s most advanced in-house compound is OATD-02, an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer that is expected to advance to Phase 1 in the fourth quarter 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 https://molecure.com/en/ LinkedIn: molecure-sa | Twitter: @molecure_sa | YouTube: Molecure SA

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