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

OncoArendi Therapeutics Reports Continued Strategic and Operational Momentum for 12 Months ended 31 December 2021

 – 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

***

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

OncoArendi Therapeutics Announces a License Option Agreement with University of Michigan

– Option to in-license and develop small molecule leads against a novel target for the treatment of fibrotic diseases

– Strengthens pipeline and reinforces OncoArendi’s strategic focus on fibrotic diseases including idiopathic pulmonary fibrosis (IPF)

11 March  2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), a clinical stage biotechnology 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, announces it has entered into an option-to-license agreement with Innovation Partnerships at the University of Michigan (U-M)  to develop novel small molecule inhibitors of an undisclosed target, for the treatment of fibrotic diseases.  The novel inhibitors were generated and initially validated as a result of a long-standing research collaboration with Michigan State University (MSU).  U-M entered in the option-to-license agreement with OncoArendi on behalf of both U-M and MSU.

– Option to in-license and develop small molecule leads against a novel target for the treatment of fibrotic diseases

– Strengthens pipeline and reinforces OncoArendi’s strategic focus on fibrotic diseases including idiopathic pulmonary fibrosis (IPF)

11 March  2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), a clinical stage biotechnology 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, announces it has entered into an option-to-license agreement with Innovation Partnerships at the University of Michigan (U-M)  to develop novel small molecule inhibitors of an undisclosed target, for the treatment of fibrotic diseases.  The novel inhibitors were generated and initially validated as a result of a long-standing research collaboration with Michigan State University (MSU).  U-M entered in the option-to-license agreement with OncoArendi on behalf of both U-M and MSU.

“We are thrilled to be partnering with the University of Michigan, one of the world’s leading research institutions. This collaboration seeks to capitalize on OncoArendi’s expertise in fibrotic and inflammatory diseases together with the University of Michigan’s capability in identifying novel targets and new small molecule leads for the treatment of multiple fibrotic diseases” said Nicolas Beuzen, Director of Business Development and Licensing. “At OncoArendi, we continue to expand and advance our novel small molecule pipeline modulating challenging protein targets involved in inflammation and fibrosis or cancer, with the potential to develop curative treatments.”

Under the terms of the agreement, OncoArendi will confirm certain properties of a series of selective small molecule inhibitors targeting this novel therapeutic target in fibrosis. OncoArendi will then have the option to obtain exclusive rights for a worldwide license to these inhibitors.

“We are pleased to enter into a partnership with OncoArendi, which has a proven track record of success in preclinical, clinical and business development in fibrotic diseases,” said Bryce Pilz, Executive Director of Licensing and Strategic Alliances at U-M Innovation Partnerships. “The University of Michigan, as well as MSU, is committed to positively impacting society, and together with OncoArendi we hope to contribute to the advancement of potential breakthrough therapeutics for these under-served diseases.”

Lead molecules against this novel target have shown significant efficacy in multiple animal models of fibrosis, including pulmonary fibrosis, and superior ability to affect the course of the disease compared to the existing standard of care.

Adam Golebiowski, VP Research Chemistry and co-founder of OncoArendi added, “We are confident that we can use our medicinal chemistry engine to unlock the potential of inhibiting this novel target and optimize lead molecules against it. This alliance with U-M as with our other academic partners is key to building our pipeline of first in class assets.”

***

About OncoArendi

OncoArendi is a clinical stage biotechnology 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

About Innovation Partnerships University of Michigan

Innovation Partnerships, a unit based in the Office of the Vice President for Research at the University of Michigan, is the primary gateway for U-M researchers seeking to increase the impact of their work by connecting with the private sector. Innovation Partnerships’ team of experts help amplify the impact of U-M research through corporate-sponsored research collaborations, licensing and intellectual property strategies and connections with business mentors, entrepreneurs and investors to support startup company formation.

For more information, please visit https://innovationpartnerships.umich.edu

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

OncoArendi Therapeutics Appoints Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska to its Management Board  

New members to bring additional scientific, operational and HR expertise 

Warsaw, Poland – 31 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointments of Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska to its Management Board. These appointments bring further scientific expertise as well as enhanced organizational and development capabilities to the Management Board.New members to bring additional scientific, operational and HR expertise 

Warsaw, Poland – 31 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointments of Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska to its Management Board. These appointments bring further scientific expertise as well as enhanced organizational and development capabilities to the Management Board.  

“I am pleased to welcome Adam, Zbigniew and Agnieszka as new members of the Management Board. They are all specialists and experts in their fields, and their experience and knowledge will build on and enhance the competencies of our existing Board,” said Marcin Szumowski CEO and President of the Management Board. “OncoArendi has made great progress as we work towards building out a pipeline of innovative small molecule drugs targeting both mRNA and challenging protein disease targets. Adam and Zbigniew bring deep scientific knowledge and experience and will play a pivotal role in helping us further broaden our pipeline. Agnieszka’s appointment adds significant expertise in human resources, talent management and people operations, at a time when we are continuing to rapidly grow and diversify our organization, to deliver on our ambitious goals. “  

Dr. Adam Gołębiowski, who is a co-founder of OncoArendi brings over 20 years of experience in leading research and development and drug discovery programs. In 1987 he completed his doctorate at the Institute of Organic Chemistry of the Polish Academy of Sciences, followed by a postdoctoral fellowship at Wayne State University, Michigan, USA.  From 1989 to 2006, he led teams of medicinal chemists and research programs at Procter & Gamble Pharmaceuticals. From 2006 to 2012, he led research at the Institutes for Pharmaceutical Discovery (IPD) in Connecticut, USA.  He is author of over 30 patents, 100 original publications, review articles and books. 

Dr. Zbigniew Zasłona currently serves as Director of Biology at OncoArendi. He obtained his PhD in 2010 at the University of Giessen and the Marburg Lung Center in Germany, studying the mechanisms that modulate innate immunity in the context of pneumonia. He then undertook a postdoctoral fellowship at the University of Michigan in the USA, where he focused on pharmacological studies of GPCR receptors, in particular lipid mediators of inflammation. From 2015 to October 2020, he was a research fellow at Trinity College Dublin (Ireland) in the Department of Biochemistry and Immunology, as well as a Senior Investigator at the UK biotechnology company Sitryx (which in March 2020 entered into a $1 bln collaboration and license agreementwith Eli Lilly), where he was responsible for anti-inflammatory drug development programs. Dr. Zasłona is a recognized international expert in the field of inflammatory processes and lung diseases and is repeatedly invited to lecture at leading international scientific conferences. 

Agnieszka Rajczuk-Szczepańska currently serves as the Human Resources (HR) Director at OncoArendi. She has over 25 years of experience in HR, including over 10 years in managerial positions. As HR Director, she is responsible for recruitment, on-boarding, motivation, training and employee development, competence assessment and talent development management, work efficiency management and building employee engagement. She is a graduate of the University of Wrocław in the field of psychology with a specialization in organization and management. She also completed post-graduate studies in human resources management and labor law at the Kozminski University in Warsaw. She is a co-founder of the Polish HR Association in Poland. 

Recently, OncoArendi also announced the hire of Dr. Samson Fung as Chief Medical Officer, ahead of the company starting the planned clinical development of OATD-02, a dual arginase inhibitor, in the second half of 2022. 

*** 

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 

About OncoArendi 

OncoArendi is 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 underexplored protein targets to treat multiple incurable diseases.  

OncoArendi’s world class medicinal chemistry has allowed it to generate a diverse pipeline of nine distinct programs with the support of leading academic life science institutions globally, these include the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science. 

OncoArendi has an exclusive collaboration and license agreement with Galapagos for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 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 laboratory 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 

OncoArendi Therapeutics Appoints Samson Fung, M.D. as Chief Medical Officer

Dr. Fung to Lead Global Clinical Development, Translational Science and Regulatory Strategies

Warsaw, Poland – 27 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointment of Samson Fung, M.D. as Chief Medical Officer. Dr. Fung will be responsible for the company’s global clinical development, translational science and regulatory strategies and will lead the advancement of OATD-02, its novel dual arginase inhibitor into Phase 1.

Dr. Fung to Lead Global Clinical Development, Translational Science and Regulatory Strategies

Warsaw, Poland – 27 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointment of Samson Fung, M.D. as Chief Medical Officer. Dr. Fung will be responsible for the company’s global clinical development, translational science and regulatory strategies and will lead the advancement of OATD-02, its novel dual arginase inhibitor into Phase 1.

“Samson’s extensive experience in drug development and translational medicine together with his background in oncology and deep knowledge gained working at blue-chip biopharmaceutical companies, makes him a crucial addition to our team,” said Marcin Szumowski, CEO and President of the Management Board.  We are delighted to welcome Samson at this exciting time as we prepare to progress our pipeline of first in class cancer and fibrosis therapies, including our lead wholly owned candidate OATD-02, a highly potent dual arginase inhibitor, which is on track to start Phase 1 in the second half of 2022. “

Dr Fung added, “I am thrilled to be joining OncoArendi at such an important stage of its development. I am looking forward to working with the company’s talented team to build a robust pipeline of small molecule drugs that has the potential to transform the care of cancer and fibrosis patients around the world. “

Dr Fung brings more than two decades of global industry and senior leadership experience across the life science sector.

He has significant biotech experience with senior leadership roles (Head of Clinical Development, interim CMO) at several of Europe’s most successful biotech companies including argenx, Micromet, later acquired by AMGEN, and Morphosys.

Dr. Fung has also held senior roles in clinical development, medical affairs, business development and strategic marketing at leading global pharmaceutical companies including Roche, Novartis, Pharmacia/Pfizer, Novo Nordisk and AstraZeneca.

Dr. Fung graduated from the University of Freiburg, Germany and obtained his board certification in internal medicine with sub-specialization in oncology and hematology.

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

About OncoArendi

OncoArendi is 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 underexplored protein targets to treat multiple incurable diseases.

OncoArendi’s world class medicinal chemistry has allowed it to generate a diverse pipeline of nine distinct programs with the support of leading academic life science institutions globally, these include the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

OncoArendi has an exclusive collaboration and license agreement with Galapagos for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 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 laboratory 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

OncoArendi Therapeutics supervisory board welcomes international biopharmaceutical experts: Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński as its new members

OncoArendi Therapeutics supervisory board welcomes international biopharmaceutical experts: Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński as its new members

Appointments bring global leadership experience and expertise in drug discovery, as well as clinical and business development

Warsaw, Poland – 14 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointment of Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński to its Supervisory Board. These appointments bring considerable international experience to the Company across all stages of drug development as well as in finance and business development.

OncoArendi Therapeutics supervisory board welcomes international biopharmaceutical experts: Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński as its new members

Appointments bring global leadership experience and expertise in drug discovery, as well as clinical and business development

Warsaw, Poland – 14 January 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), 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 the appointment of Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński to its Supervisory Board. These appointments bring considerable international experience to the Company across all stages of drug development as well as in finance and business development.

Marcin Szumowski, Co-founder & CEO, commented, ”We are pleased to welcome Nancy, Paul and Rafal as new members to the Supervisory Board.  Together, they bring a deep understanding of medicine and extensive global experience in drug and business development. The breadth of knowledge Nancy and Rafal have gained in working at leading science-driven companies and Paul’s broad experience as a senior business executive and successful track record of business transactions will be invaluable as we plan to advance our portfolio of innovative assets targeting both protein and mRNA targets.”

Dr Nancy Van Osselaer, PhD

Dr Van Osselaer is an experienced global biopharmaceutical professional with over 25 years experience leading drug development projects at leading pharmaceutical companies. Nancy currently serves as an independent consultant for her company Why2What, which provides strategic implementation advice to biotech companies.

Nancy was previously Vice President Early Stage Development portfolio leader at Galapagos, where she was responsible for the strategy and development of early assets, including the cystic fibrosis program and various highly innovative assets in the immune-inflammation space. Before joining Galapagos, Nancy worked at UCB where she worked to identify better outcomes for neurology patients beyond the current treatment regimes.

Prior to this, Nancy spent over 17 years at Johnson and Johnson contributing to multiple registration files and participating in development review committees.

Nancy is a pharmacist by training and holds a PhD in pharmacology from the University of Antwerp, Belgium.​

Dr Paul van der Horst, PhD

Dr van der Horst has a strong track record of biotech business development having acted as lead negotiator in over 20 licensing and M&A transactions and raised over $1.3 billion through capital market transactions during his career.

Paul currently serves as Chief Business Officer at Agomab Therapeutics and prior to joining Agomab, he was Head of Corporate Development at Galapagos. In this role, he led all major transactions, investments, licensing and M&A activities, most notably, a key negotiator for Galapagos’ transformative $5bn strategic collaboration with Gilead Sciences.

From 2013 to 2016, Paul worked at Kempen & Co a boutique investment bank with specialist expertise in life sciences and healthcare, where he was responsible for transatlantic brokerage and investor transactions related to European pharmaceutical and biotech stocks.

Paul studied medicine and holds a PhD in Gynaecological Oncology from the Erasmus University Medical Centre in Rotterdam. Paul is a member of the Board of Directors at ImmuneTune.

Dr Rafał Kamiński, MD, PhD

Dr Kamiński has over 20 years experience in drug discovery, clinical candidate delivery and late stage development alongside global R&D and industry leadership experience. He  was previously the Company’s Scientific Officer and a member of its Management Board. Dr Kaminski will shortly be taking up an executive position as Chief Scientific Officer at Angelini Pharma, the pharmaceutical division of Angelini Industries.

Prior to joining OncoArendi in 2020, Rafal spent over 13 years at UCB and Roche, in senior medical positions in neurology and experimental therapeutics. At both companies, he was responsible for the strategy and portfolio of preclinical projects and selection of clinical candidates, leading the R&D teams.

Rafal obtainined his medical degree and pharmacology doctorate at the Medical University of Lublin (Poland), completing his post-doctoral training at Radboud University, Netherlands and the National Institute of Health, serving as a research and visiting fellow for over 7 years, gaining expertise in neurology, oncology and inflamatory disease.

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

About OncoArendi

OncoArendi is 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 underexplored protein targets to treat multiple incurable diseases.

OncoArendi’s world class medicinal chemistry has allowed it to generate a  diverse pipeline of nine distinct programs with the support of leading academic life science insitutions globally, These include the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

OncoArendi has an exclusive collaboration and license agreement with Galapagos for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 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 and 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

OncoArendi continues to grow by executing further steps of the strategy and initiates two new drug discovery programs within its existing research platforms

According to the strategy released in March, OncoArendi Therapeutics S.A. (WSE: OAT) expands its existing innovative drug discovery platforms by launching two new programs: CHIT1 SELECTIVE focusing on new therapeutic areas within the chitinase platform and a new program in the deubiquitinase (DUBs) platform in oncology indications. These activities are in line with strategic plans announced for the coming years leading to dynamic growth and expansion into new therapeutic targets.

According to the strategy released in March, OncoArendi Therapeutics S.A. (WSE: OAT) expands its existing innovative drug discovery platforms by launching two new programs: CHIT1 SELECTIVE focusing on new therapeutic areas within the chitinase platform and a new program in the deubiquitinase (DUBs) platform in oncology indications. These activities are in line with strategic plans announced for the coming years leading to dynamic growth and expansion into new therapeutic targets.

The selective CHIT1 inhibitor will be developed as a potential therapy for non-alcoholic steatohepatitis (NASH) and / or a broad spectrum of neurological diseases that are characterized by excessive activation of inflammatory cells. Progress in development of drug candidates in this therapeutic area depends on the ability to optimize the developed compounds for blood-brain barrier permeability.

The second new program, launched in the DUBs platform, builds on the experience gained by the Company research team in this area and naturally expands the pool of therapeutic targets in the ubiquitin-specific protease (USP) family. Inhibiting the activity of the newly selected enzyme from the USP group (specific protein from the USP family will not be disclosed at this stage) opens the possibility of innovative and unique therapeutic approaches in immuno-oncology.

“Expanding our drug discovery portfolio with these new programs is a natural continuation of the development of the existing platforms in the Company’s pipeline, in which we have built unique scientific and research experience. The CHIT1 SELECTIVE inhibitor program is the next step in expansion of the chitinase platform and provides opportunities to further leverage the Company’s collaboration agreement with Galapagos. At the same time the new program in the DUBs platform allows us to optimize the use of experience and talent of our research team to most effectively implement our expanded R&D strategy. We can see that immuno-oncology has become one of the most dynamically growing areas in biotechnology, therefore we aim at best utilization of our competences in this realm.” – says Rafał Kamiński, Member of the Board and Chief Scientific Officer of OncoArendi Therapeutics.

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