Category: News
Warsaw, Poland – 5 December 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company using its world leading medicinal chemistry capabilities to discover first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces agenda topics and participating key opinion leaders for its virtual R&D Day.
The webcast event will be hosted by Molecure on the 7th December 2022 at 13.30 – 16.30 CET / 12.30 – 15.30 BST/ 7.30 – 10.30 ET.
The meeting is available here:
https://us06web.zoom.us/j/84261604213?pwd=QTlVZytQTWFUd3Y1N080R2hwWGZydz09
The presentations by Key Opinion Leaders and Molecure management will showcase the scientific insights and clear clinical needs that underpin Molecure’s pipeline programs.
Agenda topics:
13.30-15.30
- Molecure’s Vision, Strategy and Pipeline
- OATD-01, Molecure’s first in class chitinase inhibitor:
- Clinical evaluation in sarcoidosis and potential patient impact (Prof. Krenke)
- Landscape and therapy opportunity in sarcoidosis
- Clinical development plan
- Other opportunities in interstitial lung disease
- OATD-02, Molecure’s novel dual arginase inhibitor:
- Pre-clinical activity in a broad range of cancers
- State of oncology in Poland (Prof. Szczylik)
- Clinical development plan
15.30-15.40 Break
15.40-16.30
- Early-stage pipeline
- Deubiquitinating enzymes (DUBs) program including USP7 in oncology
- YKL40 in oncology
- University of Michigan collaboration in fibrosis
- mRNA platform
Key Opinion Leader Presenters:
- Rafal Krenke, Pulmonologist, Head of Department of Internal Medicine, Pulmonary Diseases & Allergy, Medical University of Warsaw
- Cezary Szczylik, Oncologist, Head of the Department of Clinical Oncology and Chemotherapy Europejskie Centrum Zdrowia (European Health Center) Otwock
Molecure S.A. Presenters:
- Dr Marcin Szumowski – CEO, President of the Board
- Dr Zbigniew Zasłona – VP Research Biology, Member of the Board
- Dr Samson Fung – Chief Medical Officer
- Dr Nicolas Beuzen – Director of Business Development and Licensing
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 globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).
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.
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 www.molecure.com
LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA
- 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 28th of November 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 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
+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/
LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA
Warsaw, Poland – 14 November 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry capabilities to discover first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, will host a virtual R&D Day on the 7th December 2022 at 13.30 CET / 12.30 BST / 6.30 ET.
During this event, management and scientific leaders will provide a comprehensive review of Molecure’s the company’s pipeline.
The event will provide updates on Molecure’s clinical development plans and related near-term catalysts, with a focus on its two novel drug candidates, OATD-01, a first in class chitinase inhibitor for sarcoidosis and OATD-02, a dual acting, highly potent arginase inhibitor for a broad range of cancers.
Date: 7th December 2022
Time: 13.30 – 16.30 CET
The agenda and details of how to join the meeting will be available in an invitation and on the Company’s website (www.molecure.com) which will be issued closer to the time of the event.
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
+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 globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).
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 https://molecure.com/pl/
LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA
Molecure Third Quarter 2022 Pipeline Highlights and Financial Results
- Proprietary pipeline progressing in-line with our strategic objectives for 2022-2025
- Lead proprietary candidate, OATD-01 a novel chitinase inhibitor in sarcoidosis expected to advance into a Phase II study in mid-2023
- Second proprietary candidate, OATD-02, a first in class arginase inhibitor for cancer on track to enter Phase I clinical trials in late 2022, following CTA approval
Warsaw, Poland – 31 October 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 unexplored protein and RNA targets to treat multiple incurable diseases, announces third quarter results for the period ended 30 September 2022. The full report in Polish can be found here.
“We are delighted with the progress we are making on our strategic objectives, accomplished year to date,” said Marcin Szumowski, CEO and President of the Management Board of Molecure. “Our confidence in OATD-01’s potential to be a best and first in class disease modifying therapy for sarcoidosis has been enhanced over the period as a result of our discussions with a group of leading global experts and clinicians in sarcoidosis. Their input has also been important to ensure the successful planning and execution of this high priority clinical program. We are equally excited about the opportunity for OATD-02 in cancer, given this novel molecule’s clearly differentiated mode of action, and remain on track to start a Phase I study in late 2022.”
Molecure R&D Day
Molecure will host an R&D Day in the first half of December 2022. During this event, management and scientific leaders will provide a comprehensive review of the company’s pipeline. The event will provide updates on our development plans and related near-term catalysts, with a focus on OATD-01 and OATD-02 for sarcoidosis and cancer respectively.
Commercial & Operational Highlights
- Preparations for a multi-centre Phase II trial for OATD-01 in sarcoidosis
- Multiple discussions with leading pulmonologists & opinion leaders have taken place to help shape the planned clinical development program in sarcoidosis
- Data generated to date shows attractive benefit-risk profile and together with the scientific advice received from the EMA are highly supportive of further progressing OATD-01 into Phase II clinical trials expected to start in mid-2023
- This novel drug candidate has potential in several other respiratory indications, other ILDs and NASH
- CTA for OATD-02 filed with Polish regulator in August, following successful completion of preclinical studies
- 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 at the end of 2022 to assess safety of OATD-02 in patients with advanced and/or metastatic solid tumors. The planned trial has already received a positive opinion from the bioethics committee in Poland
- Publication* (August) entitled, “OATD-02 Validates the Benefits of Pharmacological Inhibition of Arginase 1 and 2 in Cancer”
- This is the first study validating the benefits of pharmacological inhibition of ARG2 in cancer and demonstrates that OATD-02 is a potent dual ARG1/ARG2 inhibitor with cellular activity (necessary for targeting ARG2) and exhibiting immunomodulatory and direct antitumor efficacy in animal models
* https://www.mdpi.com/2072-6694/14/16/3967
- Further development of mRNA platform
- Continued development of platform, as Molecure applies a range of analytical techniques to confirm the secondary structure of 6 most promising target regions
- Ongoing collaborations with global leading RNA centres to further leverage the company’s expertise and alternative approach to identify compounds interacting with selected mRNA regions
- Partnering events and investor conferences
- Post period end, CEO, Marcin Szumowski and business development director, Nicolas Beuzen attended partnering conference Bio-Europe in Leipzig, Germany in October. The event brought together thousands of outstanding biopharma companies enabling meaningful partner discussions
- The company will attend a number of partnering and investor events before the end of 2022 including the Jefferies Healthcare conference in London in November, the largest healthcare conference held in Europe each year
Third Quarter Financial Highlights
- Operating income totaled PLN0.24 million, a slight decrease yoy due to lower subsidies booked from public grants compared to the same period in 2021.
- Operating expenses totaled PLN3.49 million, an increase of PLN1.26 million. This was mainly due to higher R&D costs as the company’s pipeline advances, the cost of external services, wages and rebranding activities.
- Net loss for the 3 months ended 30 September 2022 totaled PLN2.46 million.
- As of September 30, 2022, Molecure had cash of PLN80 million (US$16 million).
- Current funds are expected to fund the company’s operating expenses and capital expenditure requirements for the next 18-20 months.
- US$/PLN exchange rate 5.0 as of 30 September 2022
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, 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 globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).
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
- 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
Warsaw, Poland – 29 September 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 interim results for the six months ending 30 June 2022. The full report in Polish can be found here https://molecure.com/pl/informacje-dla-inwestorow/
Marcin Szumowski, CEO and President of the Management Board of Molecure commented: The last 6 months has been a period of significant transformation for Molecure. We unveiled our new identity in April as Molecure (formerly OncoArendi Therapeutics). This significant change reflects and highlights our growing ambition, passion and ongoing commitment to discover and develop novel small molecule therapies for millions of people with serious and incurable diseases.
I am pleased with the progress that the team has made to advance and expand our portfolio of products including establishment of a new mRNA discovery platform. We intend to build on our balanced pipeline and accelerate its progress in the remainder of 2022 and beyond.
Molecure is entering a very exciting stage in its development with a number of potential near-term value creating milestones set to be achieved from its pipeline portfolio. These include regulatory clearance and launch of a Phase II proof-of-concept study for OATD-01 in sarcoidosis patients in mid-2023. We believe that OATD‑01, a novel chitinase inhibitor with first-in-class potential has a key role to play in multiple inflammatory and fibrotic diseases. It is also a front-runner in creating future value for our shareholders and the start of the Phase II trial will be a significant corporate milestone. Following the strategic review by Galapagos, Molecure now retains all global commercial rights to this molecule.
We have also made excellent progress with OATD-02, a first-in-class dual arginase inhibitor for the treatment of cancer that has recently successfully completed preclinical development. A CTA was filed for OATD-02 with the Polish regulator on August 11 with a decision expected in late October, paving the way for us to start Phase I clinical trials in December 2022.
We are also continuing to explore and optimize our mRNA platform that aims to generate small molecule RNA-binding drugs that can address a range of difficult to drug targets.
Our value generating strategy is based on a diverse set of growth opportunities and I am confident that our expertise in medicinal chemistry and the biology of low-grade inflammation leading to tissue remodeling, and cancer will enable us to generate disease modifying treatments to improve the lives of many people.
Investor presentation
The Molecure leadership team will host a live online/in-person presentation relating to the interim results via a live webcast on 29 September 2022 at 2:30pm CET. The presentation and recording will be available on the Company’s YouTube channel: Molecure SA.
Commercial & Operational Highlights
- Rights regained to 0ATD-01, following Galapagos strategic pipeline review
- Data generated to date shows attractive benefit-risk profile and together with the scientific advice received from the EMA are highly supportive of further progressing OATD-01 into Phase II clinical trials expected to start in mid-2023
- Sarcoidosis has been chosen as the initial indication for the Phase II study
- Further potential in several other respiratory indications, other ILDs and NASH
- CTA for OATD-02 filed with Polish regulator in August, following successful completion of preclinical studies
- 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 at the end of end 2022 to assess safety of OATD-02 in patients with advanced and/or metastatic solid tumors.
- Rapid development of USP-7 inhibitors program
- Continued development of program, selected lead molecule with high in vitro activity confirms its in-vivo effectiveness in the syngeneic colorectal cancer model showing a dose-dependent inhibition of tumor growth
- Further development of mRNA platform
- Continued development of platform, as Molecure applies a range of analytical techniques to confirm the secondary structure of 6 most promising regions
- Currently, work is being carried out on modeling the tertiary structure of these identified mRNA fragments, which in the next stage will allow for the launch of work aimed at discovering compounds that bind these targeted regions
Key organizational changes to drive the Company through its next phase of evolution
- Internal team members appointed to the Management Board: Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska
- Appointment of Samson Fung, M.D., PhD, as Chief Medical Officer to lead global clinical development, translational science and regulatory strategies. Dr Fung will lead the advancement of 0ATD-01 and OATD-02 into Phase II and Phase I clinical trials respectively
- Supervisory board expanded to include Nancy Van Osselaer, Paul van der Horst and Paweł Trawkowski as its new members
Important Post-period Highlights
- Significant progress made on OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer expected to enter the clinic in late 2022.
- Publication* (17th August) titled, “OATD-02 Validates the Benefits of Pharmacological Inhibition of Arginase 1 and 2 in Cancer”. This is the first study validating the benefits of pharmacological inhibition of ARG2 in cancer and demonstrates OATD-02 as a potent dual ARG1/ARG2 inhibitor with a cellular activity (necessary for targeting ARG2) exhibiting immunomodulatory and direct antitumor efficacy in animal models
* https://www.mdpi.com/2072-6694/14/16/3967
First Half Financial Highlights
- Operating income totaled PLN1.25 million (US$275,000), an increase of PLN0.69 million (US$129,400) due to subsidies received from public grants
- Operating expenses totaled PLN8.66 million (US$1.91 million), an increase of PLN3.07 million (US$451,800). This was mainly due to higher R&D costs as the company’s pipeline advances, the cost of external services, wages and rebranding activities
- Net loss for the 6 months ended 30 June 2022 totaled PLN7.06 million (US$1.55 million). This was due to higher operating expenses as above
- As of June 30, 2022 Molecure had cash of PLN82.78 million (US$18.2 million)
- Current funds are expected to fund the company’s operating expenses and capital expenditure requirements into mid-2024.
- US$/PLN exchange rate 4.54 as 30 June 2022
- US$/PLN exchange rate 3.84 as 30 June 2021
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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
+44 (0)203 928 6900
- 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
+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
- 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
– Significant partnership agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) to accelerate the strategic development of OncoArendi’s small molecule RNA platform
– Novel dual acting first-in-class arginase inhibitor OATD-02 scheduled to begin Phase 1/2 clinical trials in 2022
Warsaw, Poland, 25 March 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), a clinical stage biopharmaceutical company that uses its world leading medicinal chemistry 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, provides an update on operational activities and reports its consolidated results for the 12 months ended 31 December 2021. The full report in Polish can be found here.
Marcin Szumowski, CEO and President of the Management Board of OncoArendi commented: “We have made excellent progress during 2021 on key strategic initiatives including establishing a significant partnership agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) to accelerate the development of our small molecule RNA targeting discovery platform. We have also successfully completed preclinical development of our novel dual acting first-in-class arginase inhibitor OATD-02, which is scheduled to begin Phase 1/2 clinical trials in 2022 for patients with different types of cancer, further validating our world leading medicinal capabilities and translational expertise.
Our progress in 2021, followed a key success in late 2020 when we signed an exclusive license agreement with Galapagos for the global development and commercialization of OATD-01 (now GLPG4716). Galapagos is planning the further clinical development as it prepares to advance GLPG4716 into Phase 2, which could generate significant revenues over the coming years if milestones are reached successfully.
Our strong balance sheet supports our ability to drive our organic, in-licensing and partnering opportunities that complement our existing expertise and could allow further value to be realized from our small molecule programmes and RNA discovery platform in the future. Further, the planned leadership changes announced recently are aimed at bringing new insights and drive to the Company as we evolve towards our goal of becoming a leading global biopharmaceutical company developing lifesaving therapies for people around the world.
We continue to be guided by our expertise in medicinal chemistry and biology of inflammatory disease and cancer to generate best-in-class treatments and look forward to achieving upcoming milestones across our portfolio in 2022.”
Operational highlights for 2021
- New strategic collaboration and licensing agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) accelerates the Company’s development of small molecule drug candidates that directly modulate mRNA function
- Successful completion of preclinical development of OATD-02, a first-in-class dual acting arginase inhibitor for the treatment of cancer, due to start First-In-Human Phase 1/2 in the second half of 2022
Important Post-period Highlights
- New license option agreement with University of Michigan to develop small molecule leads against a novel target for the treatment of fibrotic diseases
Key organizational changes to drive the Company through its next phase of evolution
- Internal team members appointed to the Management Board: Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska
- Appointment of Samson Fung, M.D., PhD, as Chief Medical Officer.
- Supervisory board expanded to include Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński as its new members
Financial Highlights for the 12-month Period ended 31 December 2021
- Operating income totalled PLN1.46 million (US$335,800), a decrease of PLN123.45 million (US$28.39 million). This was due to an upfront payment of US$28 million being received in 2020 from the deal with Galapagos.
- Operating expenses totalled PLN15.22 million (US$3.50 million), a decrease of PLN35.99 million (US$8.28 million) from 2020. This was due to transaction costs and R&D expenses associated with the Galapagos deal signed in 2020.
- Net loss for the 12-months ended 31 December 2021 totalled PLN13.64 million (US$3.13 million). In 2020 the company made a profit of PLN64.27 million (US$14.78 million) due to the upfront payment from the Galapagos deal.
- As of December 31, 2021, OncoArendi had cash of PLN102m (US$23.46 million)
- Current funds are expected to fund the company’s operating expenses and capital expenditure requirements into the 4th quarter of 2023.
US$/PLN exchange rate 4.35
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About OncoArendi
OncoArendi is a clinical stage biopharmaceutical company that uses its world leading medicinal chemistry capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and underexplored protein targets to treat multiple incurable diseases.
OncoArendi has generated a diverse pipeline of nine 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.
OncoArendi’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 second half of 2022.
OncoArendi has an exclusive collaboration and license agreement with Galapagos for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 (GLPG4716) is a Phase 2-ready chitotriosidase/acidic mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases with a fibrotic component.
OncoArendi’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratories in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: OAT).
For more information, please visit https://oncoarendi.com/en/ LinkedIn: @OncoArendi Therapeutics | Twitter: @oncoarendi | YouTube: @ OncoArendi Therapeutics
For further information, please contact:
OncoArendi (PR & IR)
Magdalena Licka
Email : m.licka@oncoarendi.com
MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin
Email: OncoArendi@medistrava.com