Category: News

– 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.”

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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

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 

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

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

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.

Galapagos has posted on CT.gov (https://clinicaltrials.gov/ct2/show/NCT04971746) the start of a clinical trial with GLPG4716 (OATD-01) to evaluate potential pharmacokinetic drug-drug interactions with pirfenidone and nintedanib, which are drugs that are approved and standard of care for treatment of idiopathic pulmonary fibrosis (IPF). Since in a future phase 2 trial in IPF patients GLPG4716 (OATD-01) would have to be given on top of standard of care, it is important to investigate at what doses GLPG4716 can be combined with these drugs.

Galapagos has posted on CT.gov (https://clinicaltrials.gov/ct2/show/NCT04971746) the start of a clinical trial with GLPG4716 (OATD-01) to evaluate potential pharmacokinetic drug-drug interactions with pirfenidone and nintedanib, which are drugs that are approved and standard of care for treatment of idiopathic pulmonary fibrosis (IPF). Since in a future phase 2 trial in IPF patients GLPG4716 (OATD-01) would have to be given on top of standard of care, it is important to investigate at what doses GLPG4716 can be combined with these drugs.

After signing in November 2020 an exclusive cooperation agreement and license agreement for the global development and commercialization of OATD-01 between Galapagos NV and OncoArendi Therapeutics S.A., the Belgian partner decided on the next steps in the development of the molecule. GLPG4716 (OATD-01) is an inhibitor of chitotriosidase and acidic mammalian chitinase (CHIT1/AMCase), ready to start phase 2, for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrosis diseases.

Idiopathic pulmonary fibrosis (IPF) is a rare disease. The estimated number of IPF patients worldwide varies greatly from less than 200,000 diagnosed cases in the 7 major markets to as many as 3 million globally. It can be assumed that the market demand for a new drug is about 500 thousand worldwide. After diagnosis, the patient with IPF survives an average of 3-5 years. Often, lung cancer develops in IPF patients. In the treatment of IPF, 2 drugs are currently approved, which have severe restrictions on use due to significant side effects.

· On June 16 2021, the Company signed a scientific cooperation agreement with the International Institute of Molecular and Cell Biology in Warsaw (IIMCB) in the field of discovery and development of small molecule drugs modulating the function of RNA

· OncoArendi also entered exclusive negotiations with IIMCB of a licensing agreement (License Execution Agreement) for the rights to a unique bioinformatics software (the Bioinformatics Platform)

The agreement signed between OncoArendi and IIMCB launches a new, strategic area of research cooperation. It focuses on the development of the SMR Platform, i.e. the platform of small molecules targeting RNA. Discovery and development of small molecule drugs modulating RNA function with the use of innovative bioinformatic tools is one of the three key R&D areas of the Company’s strategy for growth in 2021-2025.

· On June 16 2021, the Company signed a scientific cooperation agreement with the International Institute of Molecular and Cell Biology in Warsaw (IIMCB) in the field of discovery and development of small molecule drugs modulating the function of RNA

· OncoArendi also entered exclusive negotiations with IIMCB of a licensing agreement (License Execution Agreement) for the rights to a unique bioinformatics software (the Bioinformatics Platform)

The agreement signed between OncoArendi and IIMCB launches a new, strategic area of research cooperation. It focuses on the development of the SMR Platform, i.e. the platform of small molecules targeting RNA. Discovery and development of small molecule drugs modulating RNA function with the use of innovative bioinformatic tools is one of the three key R&D areas of the Company’s strategy for growth in 2021-2025.

This cooperative research will include enhancement and optimization of the Bioinformatics Platform and the embedded computer programs, which will be used to discover new small molecules. Under this agreement OncoArendi will finance research at IIMCB in the net amount of 2.5 million PLN. The agreement also stipulates that OncoArendi will spend at least 2 million PLN covering its internal R&D expenses.

– The mRNA technology has the potential to become a breakthrough therapeutic approach in the treatment of previously incurable diseases. It will open access to new biological targets hidden in the sequence of human RNA, which were previously inaccessible to conventional medicines – we are talking about thousands of new possible interactions for drugs of the future, which we plan to develop. Moreover, by interfering with the RNA function, we can obtain a therapeutic effect at an early stage of the disease, before the synthesis of pathogenic proteins occurs. Therefore, we will strike directly at the source of the disease, before its irreversible consequences occur – says Rafał Kamiński, Member of the Board, Scientific Director (CSO) of OncoArendi Therapeutics S.A.

At the same time, OncoArendi and IIMCB entered into exclusive negotiations to in-license the Bioinformatics Platform, which will enhance and accelerate the process of screening for and designing new drugs in the Company’s SMR Platform. A six-month period of exclusivity has been agreed by the parties until the signing the License Execution Agreement.

During this period of exclusive negotiations, due diligence will be conducted on the scope of the licensed IP and know-how and the functionality of the Bioinformatics Platform will be validated for in silico predictions of the binding of small molecules to RNA fragments. IIMCB will receive from OncoArendi a one-off, non-refundable exclusivity fee in the net amount of 100.000 PLN.

The solutions and software subject to licensing were developed by the Laboratory of Bioinformatics and Protein Engineering (LBIB), headed by prof. Janusz Bujnicki at IIMCB. LBIB will also be responsible for the execution of the research tasks assigned to IIMCB under the cooperation agreement. Prof. Janusz Bujnicki is one of the pioneers and leaders of bioinformatics in Poland and an outstanding scientist exploring the structure of RNA and its interactions with other molecules. The scientific group of prof. Bujnicki has created globally unique algorithms and bioinformatics software, which are an important element in the discovery of new drugs targeting RNA. The innovativeness of the Bioinformatics Platform and the extensive RNA structure and function knowledge of prof. Bujnicki’s team offer a technological competitive advantage over other international companies developing small molecule drugs modulating RNA function.

– A key element of our cooperation with OncoArendi is to apply computer methods developed by my team to study the interaction of small chemical molecules with RNA. We have a unique software and appropriate know-how to find the right molecules that bind to the desired targets in RNA and to study the influence of this binding on the RNA structure. Together with OncoArendi, we aim to identify molecules binding to RNA and exerting an appropriate functional effect – says prof. Janusz Bujnicki, head of the Laboratory of Bioinformatics and Protein Engineering at the International Institute of Molecular and Cell Biology in Warsaw.

– Collaboration in the area of the SMR Platform gives us a unique opportunity to discover and develop breakthrough therapies of the future, which, by interacting directly with RNA structures, can be used to cure numerous diseases. This is a new hot trend in the biopharmaceutical industry, with many companies seeing an opportunity for breakthrough in the pharmacological treatment of millions of patients with uncurable diseases. By expanding our collaboration in this area, we capitalize on the synergy between the unique knowledge and groundbreaking results of the Institute’s basic research, the know-how of the bioinformatics laboratory of Prof. Bujnicki and our years of experience and proven commercial success in the development of small molecules that interact with new biological targets. The International Institute of Molecular and Cell Biology in Warsaw is one of the leaders, not only in Poland but also worldwide, when it comes to research and publications on RNA biology. Our collaboration will be very significant in the long-term development of OncoArendi and we are convinced that it will contribute to the discovery and development of innovative drugs that interact with RNA – says Marcin Szumowski, President of the Management Board and Chief Executive Officer of OncoArendi Therapeutics S.A.

– The mission of IIMCB is to conduct basic research aimed at understanding the basis of human diseases at the molecular and cellular level. This knowledge can be applied to create innovative therapeutic and diagnostic methods. Studies of structure and functions of various types of RNA are the main area of activity of several research groups at the Institute, and our scientists are among world leaders in this field. To ensure that the results of our research are translated into clinical applications, IIMCB’s long-term priority is to cooperate with the pharmaceutical and biotechnology industry to strengthen the potential of Polish companies by sharing resources and expertise. Thus, the current cooperation with OncoArendi is in line with the IIMCB mission and development strategy – says prof. Marta Miączyńska, Director of the International Institute of Molecular and Cell Biology in Warsaw.

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The International Institute of Molecular and Cell Biology in Warsaw (IIMCB) is one of the most modern and highest rated (category A +) Polish research institutes in the field of life sciences. In accordance with the mission of the Institute, its scientists conduct the highest quality basic research in the field of molecular and cell biology as well as biomedical research on the pathogenesis of civilization diseases in order to search for new therapeutic strategies. In recent years, the research on RNA, its structure and functions in the human body has become the area of special interest at the International Institute of Molecular and Cell Biology in Warsaw. In addition, IIMCB has gained an international reputation also thanks to research in the areas of structural biology, protein engineering, bioinformatics, genomics, cell biology, neurobiology and neurodegeneration. Importantly, research at IIMCB is carried out at all levels of biological organization, i.e. from atoms and molecules, through cells and tissues, to entire organisms. IIMCB implements a long-term strategy of scientific development, which includes groundbreaking research directions and assumes the maximum use of the existing expertise also for cooperation with biotechnology companies.

More information at: www.iimcb.gov.pl

Media contact:

Michał Wierzchowski, cc group

tel. +48 531 613 067

e-mail: michal.wierzchowski@ccgroup.pl

Investor contact:

Katarzyna Mucha, cc group

tel. +48 697 613 712

e-mail: katarzyna.mucha@ccgroup.pl

Mechelen, Belgium and Warsaw, Poland, 5 November 2020, 22:15 CET – Galapagos NV (Euronext & NASDAQ: GLPG) and OncoArendi Therapeutics SA (WSE: OAT), announced that they have signed an exclusive collaboration and license agreement 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.  

Lung diseases like IPF are associated with an increased chitinase activity, which strongly correlates with disease stage, progression and prognosis. Chitinases (predominantly CHIT1) are involved in macrophage activation. Inhibition of chitinase activity translates into a potential therapeutic benefit, as shown in a range of preclinical models. OATD-01 has shown robust anti-fibrotic activity in multiple animal models, when compared with the standard of care.

Mechelen, Belgium and Warsaw, Poland, 5 November 2020, 22:15 CET – Galapagos NV (Euronext & NASDAQ: GLPG) and OncoArendi Therapeutics SA (WSE: OAT), announced that they have signed an exclusive collaboration and license agreement 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.

Lung diseases like IPF are associated with an increased chitinase activity, which strongly correlates with disease stage, progression and prognosis. Chitinases (predominantly CHIT1) are involved in macrophage activation. Inhibition of chitinase activity translates into a potential therapeutic benefit, as shown in a range of preclinical models. OATD-01 has shown robust anti-fibrotic activity in multiple animal models, when compared with the standard of care.

OncoArendi has developed a portfolio of CHIT1/AMCase inhibitors, of which OATD-01 is the first-in-class frontrunner. OATD-01 is a novel, small molecule CHIT1/AMCase inhibitor targeting a key pathway in tissue remodeling. It has shown compelling translational data, a favorable profile in animal studies at expected therapeutic doses and it has successfully completed Phase 1 studies in healthy volunteers. Galapagos aims to bring OATD-01 to a Phase 2 clinical trial for the treatment of IPF and possibly other diseases with a fibrotic component.

Walid Abi-Saab, Chief Medical Officer of Galapagos said: “Galapagos is very excited to gain access to OATD-01 and OncoArendi’s innovative pipeline of novel chitinase inhibitors, further strengthening and complementing our existing fibrosis portfolio. Bringing OATD-01 to our pipeline supports our ambition to lead the advancement of treatments  in fibrosis and continues to show our commitment to push boundaries in the fight against IPF, a debilitating and fatal disease”.

“Converging human biology and preclinical data indicate that chitinases are highly relevant therapeutic targets for a range of inflammatory and fibrotic diseases. This unique area of disease biology enables development of novel therapies in biomarker-driven patient populations. OncoArendi is excited about the ability to tap into the scientific and clinical development expertise of Galapagos and we enthusiastically look forward to this long-term strategic collaboration in maximizing the potential of chitinase and chitinase-like proteins in treatment of severe human diseases involving organ fibrosis” said Marcin Szumowski, CEO of OncoArendi.

In exchange for global research, development and commercialization rights, OncoArendi will receive an upfront payment of €25 million and will be eligible to receive development, regulatory and commercial milestones on licensed products, for a total potential deal value of €320 million. OncoArendi is also eligible to receive tiered royalties ranging up to low double-digits, based on future net sales. 

Additionally, under the terms of the agreement, Galapagos will pay OncoArendi €2 million for the right of first negotiation on all other earlier stage programs on its chitinase platform. OncoArendi remains responsible for all research activity until preclinical candidate selection, after which Galapagos can exercise the option to initiate negotiations to obtain development or commercialization rights for the selected molecules. Any such transaction will be subject to a separate set of payments.

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. The company’s pipeline comprises early discovery through to Phase 3 programs in inflammation, fibrosis, and other indications. Galapagos’ ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

About OncoArendi: 

OncoArendi Therapeutics SA (WSE:OAT) is a Polish innovative biotechnology company specializing in research, development and commercialization of innovative small molecule drugs for treatment of respiratory diseases and cancer. Researchers at OncoArendi study the role of chitinases and chitinase-like-proteins that provide multiple opportunities for therapeutic interventions. OncoArendi currently has a platform of distinct small molecule programs targeting this classes of proteins, which may have potential utility in diverse inflammatory and fibrotic diseases of high unmet medical need. OncoArendi is also focusing on the development of small molecule immune-modulators targeting a key enzyme involved in amino acid metabolism that allows tumor cells to hamper anti-tumor immunity and to avoid immune surveillance. OncoArendi Therapeutics’ business model is based on the discovery and development of first-in class or best-in-class small molecules, and then outlicensing its assets to larger pharmaceutical and biotechnology companies. The company has been listed on the WSE main market since April 2018. More information at www.oncoarendi.com. 

Investors:Elizabeth GoodwinVP Investor Relations +1 781 460 1784Sofie Van GijselSenior Director Investor Relations+32 485 19 14 15ir@glpg.com

Media:Carmen VroonenGlobal Head of Communications & Public Affairs+32 473 824 874Anna GibbinsSenior Director Therapeutic Areas Communications+44 7717 801900communications@glpg.com

Contacts Galapagos

Contacts OncoArendi 

Investors: Media:

Nicolas Beuzen Marta Borkowska

Director Business Development Director Operations and Communications  +48 786 811 090 +48 728 728 143

n.beuzen@oncoarendi.com m.borkowska@oncoarendi.com

Forward-looking statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with OATD-01 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of OATD-01 due to safety, efficacy or other reasons), and that Galapagos’ estimations regarding its ability to bring OATD-01 to a Phase 2 clinical trial for the treatment of IPF and possibly other fibrotic and inflammatory diseases, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

A new publication about the discovery and preclinical characterization of OATD-01, authored by the scientists from OncoArendi Therapeutics, has just been accepted by the Journal of Medicinal Chemistry (J. Med. Chem). OATD-01 is a first-in-class chitinase inhibitor, which had recently completed Phase I studies and continues its development as a clinical candidate for the treatment of sarcoidosis, idiopathic pulmonary fibrosis (IPF), and possibly other fibrotic and inflammatory diseases.

A new publication about the discovery and preclinical characterization of OATD-01, authored by the scientists from OncoArendi Therapeutics, has just been accepted by the Journal of Medicinal Chemistry (J. Med. Chem). OATD-01 is a first-in-class chitinase inhibitor, which had recently completed Phase I studies and continues its development as a clinical candidate for the treatment of sarcoidosis, idiopathic pulmonary fibrosis (IPF), and possibly other fibrotic and inflammatory diseases.

The publication describes the drug discovery program that led to the identification of OATD-01. The elements of the medicinal chemistry design, pharmacokinetics and pharmacological properties of the compound are further described in more detail, along with preclinical proof-of-concept data in a model of IPF. These experiments have been performed in-house and by a specialized Japanese CRO.

The Journal of Medicinal Chemistry is undoubtedly one of the top scientific periodicals in the field of small molecule drug discovery. The Drug Annotations series launched by the journal is intended to showcase the most important and highly innovative compounds that have the biggest potential to make a significant impact on the treatment of human diseases. Since the inception of The Drug Annotations Series over 15 years ago, only 55 compounds have received such distinction. Therefore, OncoArendi Therapeutics is very proud that the discovery and development of OATD-01 has been selected by editor Wendy Young, PhD (Senior VP, Small Molecule Drug Discovery, Genentech) to this very prestigious and highly esteemed series of articles.

“This publication is a very important milestone for OncoArendi Therapeutics, which documents not only great science, but above all, great drug discovery work with quality that is on par with leading pharma companies. This publication will make OncoArendi an even more established player in the global biotech scene and strongly mark our leadership position in the field of chitinase inhibitors” – said Dr Rafał Kaminski, Chief Scientific Officer, OncoArendi Therapeutics.

“The data published in this article is a result of several years of hard work and dedication of talented scientists and collaborators of OncoArendi. I would like to thank them all for their passion and efforts, which were recognized by the journal Editors who selected our manuscript for such a high-profile series.” – said Dr Adam Gołebiowski, senior corresponding author and one of the co-founders of OncoArendi Therapeutics.

The research that led to this publication has been co-cofinanced by the National Center for Research and Development (NCBR) in grants, POIR.01.01.01-00-0551/15 (“Development of a first-in-class small molecule drug candidate for treatment of idiopathic pulmonary fibrosis through chitotriosidase inhibition”) and by the National Institutes of Health (NIH) in SBIR grant no 1 R44 HL132721-01 – NHLBI/ NIH (“Development of an Oral Acidic Mammalian Chitinase Inhibitor to Treat Asthma”).

Publication is now available at: https://pubs.acs.org/doi/10.1021/acs.jmedchem.0c01179#

OncoArendi Therapeutics S.A. is an innovative biotech company focused on discovery, development and commercialisation of novel medicines to treat patients with pulmonary diseases and neoplasms. OncoArendi’s business model is based on discovery and development of new therapeutic compounds with the intention to out-license the medicines to pharmaceutical companies. The company develops potential first-in-class or best-in-class medicines for the treatment of diseases associated with unmet medical need. For the development of current research projects OncoArendi Therapeutics has obtained funds from private investors as well as from numerous grants co-financed by national funds, EU funds, Horizon 2020 and the US National Health Institute (NIH) following a competitive procedure. In March 2018 OncoArendi Therapeutics successfully conducted the initial public offering (IPO) which resulted in obtaining 58 million PLN for further development of its biotech projects in the future. The company was first listed on the Warsaw Stock Exchange on 19 April 2018.

For more information visit: https://oncoarendi.com/

Twitter: @oncoarendi

Additional information:

Media contact:

Michał Wierzchowski, cc group

tel. +48 531 613 067

e-mail: michal.wierzchowski@ccgroup.pl

Investor contact:

Katarzyna Mucha, cc group

tel. +48 697 613 712

e-mail: katarzyna.mucha@ccgroup.pl