OncoArendi Therapeutics to Begin the Phase 1 Clinical Evaluation of its Novel Class of Medicines

Warsaw, 09/10/2017

Healthy volunteers study initiated for OATD-01, an innovative therapy for the treatment of asthma

Warsaw, Poland, October 9, 2017 – OncoArendi Therapeutics announced today that this week the Company will initiate a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of its lead compound, OATD-01. OncoArendi Therapeutics has been granted permission from the German Federal Institute for Drugs and Medical Devices (BfArM) to begin the first-in-human clinical evaluation of its novel drug candidate.

 

OATD-01, a potent dual inhibitor of acidic mammalian chitinase (AMCase) and chitotriosidase (CHIT1), was developed as an innovative, oral therapy for the treatment of asthma. OATD-01 is the first drug candidate targeting members of the chitinase family to enter clinical development. The data obtained from the Phase 1 study will guide the design of the subsequent trial, planned to begin in 2018, where multiple ascending doses will be evaluated.

 

“The initiation of the Phase 1 clinical trial of OATD-01 is a major milestone, not only for the program, but also for the advancement of an entirely new class of drugs. It is also a significant milestone in the development of OncoArendi as it has now become a clinical-stage biotechnology company” said Marcin Szumowski, OncoArendi’s President and CEO.

About the Phase 1 Healthy Volunteers Study

This Phase 1, randomized, double-blind, dose-escalation study will evaluate OATD-01 in placebo-controlled cohorts, enrolling up to 48 subjects. The objective of the study is to investigate safety, tolerability and pharmacokinetics in healthy male volunteers evaluated in several dose cohorts within the single dose-range study. The primary outcome measures will evaluate the safety and tolerability of OATD-01 by assessing the nature and frequency of adverse events (AEs), laboratory assessments and electrocardiogram (ECG). Secondary measures will investigate the pharmacokinetics of OATD-01.

 

“Our first dosing of OATD-01 represents the culmination of years of chemistry and biology discovery as well as chemical and preclinical development work. With the recent discovery of the significant anti-fibrotic activity of OATD-01 we are very excited about the clinical prospects of the chitinase inhibitors in treatment of not only asthma but also other interstitial lung diseases including idiopathic pulmonary fibrosis or sarcoidosis” said Stanislaw Pikul, VP of Development.

About OncoArendi Therapeutics

OncoArendi Therapeutics is an innovative biopharmaceutical company dedicated to developing and commercializing novel therapeutics for inflammatory diseases associated with tissue remodelling and cancer. OncoArendi has a broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs targetting different chitinase family proteins currently in progress. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases with high unmet medical need, such as asthma, idiopathic pulmonary fibrosis (IPF), sarcoidosis, as well as diseases associated with fibrosis of other organs and some types of cancer.

More info: https://oncoarendi.com/en/home/

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OncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA)

Warsaw, 2017/07/07

OncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA) with The Federal Institute for Drugs and Medical Devices (BfArM) to conduct a Phase 1, First-in-Human, study with OATD-01, a potent dual inhibitor of Acidic Mammalian Chitinase (AMCase) and Chitotriosidase (CHIT1). OATD-01 is the first drug candidate targeting members of the chitinase family to enter clinical development. The single dose escalation study is designed to assess the safety, tolerability and pharmacokinetics of OATD-01 in healthy subjects.

OATD-01 is a non-steroidal small molecule inhibitor, which has shown excellent pharmacokinetic properties in three species after oral dosing, and the overall DMPK profile that is consistent with the targeted once-a-day oral dosing in humans. OATD-01 demonstrated significant efficacy in standard mouse models of asthma with anti-inflammatory activity equivalent or superior to montelukast (Singulair), the only approved oral drug for asthma. The results of recently completed GLP toxicology studies fully support further clinical development of OATD-01.

“We are extremely pleased to have completed this significant milestone as we continue to make progress with the development of our novel anti-inflammatory and antifibrotic treatment solutions,” stated Marcin Szumowski, President & CEO of OncoArendi Therapeutics. “We believe that therapies targeting members of the chitinase family have great potential to be transformational medicines in the treatment of several chronic inflammatory diseases.  At OncoArendi, we are dedicated to research and development of innovative therapies that could significantly advance our understanding and treatment of serious inflammatory and fibrotic diseases such as asthma, IPF, sarcoidosis, or COPD,” he continued.

Stanisław Pikul, OncoArendi’s VP of Development, commented “We are particularly excited about the therapeutic potential of OATD-01. Initiation of clinical trials is a key step towards bringing this novel drug candidate to the market as quickly as possible. Data from non-clinical studies suggest that our first clinical candidate can offer an alternative or complementary treatment to the corticosteroid-based asthma therapies such as Advair or Symbiocort. OATD-01 has an excellent safety profile and appears suitable for once-a-day oral dosing, with a completely different molecular target and mechanism of action compared to Singulair.”

Based on current projections the initial dosing of OATD-01 is expected to begin in a specialized clinical pharmacology unit in Germany in Q4 this year.

About Chitinase Science

AMCase has been shown to be upregulated during different inflammatory diseases. Its increased levels and activity were reported in airway inflammation induced by allergens in different mouse in vivo models. In humans, patients suffering from allergic diseases, including asthma, have been shown to produce increased amounts of AMCase. The second enzymatically active protein – CHIT1 is involved in development of lung fibrosis. Patients with interstitial lung diseases e.g. IPF or sarcoidosis, and COPD have strongly increased CHIT1 activity that correlates with disease severity. Accumulating evidence indicates that both enzymes are involved in the regulation of pulmonary inflammation and fibrosis-associated airway remodeling during asthma making them attractive therapeutic targets for novel drugs.

About OncoArendi Therapeutics

OncoArendi Therapeutics is an innovative biopharmaceutical company dedicated to developing and commercializing novel therapeutics for inflammatory diseases and cancer. OncoArendi has broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs directed against different chitinase family targets currently in progress. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases with high unmet medical need, such as idiopathic pulmonary fibrosis (IPF), sarcoidosis, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD), as well as tropical diseases and some types of cancer.

Contact information:

Stanislaw Pikul
VP Development
e-mail: s.pikul@oncoarendi.com

Marcin Szumowski
President & CEO
e-mail: m.szumowski@oncoarendi.com

OncoArendi Therapeutics, SA
Zwirki i Wigury 101
02-089 Warsaw
Poland

meatnetadmOncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA)
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OncoArendi Therapeutics Announces Selection of Its Second Clinical Development Candidate: OATD-02 For the Treatment of Multiple Cancers

Warsaw, Poland, June 21, 2017 / B3C newswire / — During the first Company Presentation at the global BIO Conference in San Diego OncoArendi Therapeutics SA announced that it has selected OATD‑02 as its clinical development candidate for cancer immunotherapy. Submission of the Company’s second Investigational New Drug (“IND”) application is expected by the third quarter of 2018.

OATD-02 is a highly potent and selective small molecule inhibitor of two arginase isoforms (Arg-1 and Arg-2) in both biochemical and cell-based-assays. OATD-02 is the second arginase inhibitor to enter development.

OATD-02 has been shown to be effective in vivo in three different mouse models of cancer (colorectal, lung and melanoma) and demonstrated superior antitumor efficacy in combinations with the PD-L1 checkpoint inhibitor and with gemcitabine; resulting in a controlled tumor growth, and, in some cases in a full regression.

Pilot studies  also suggested a therapeutic potential of OATD-02 in glioblastoma multiforme (GBM), the most malignant brain tumor with no effective treatment.

“We believe that small molecule drugs preventing cancer cells from escaping from the immune surveillance have great potential in combination therapies and to be transformational medicines in the treatment of many types of cancer. The increasing number of clinical trials with multiple IDO inhibitors and various check-point inhibitor combinations additionally validate this approach. At OncoArendi, we are dedicated to research and development of the first-in-class or best-in-class small molecule-based therapies that in combination with other modalities, could significantly improve the treatment of unmet medical needs in many solid and hematopoietic cancers ” said Marcin Szumowski, PhD, CEO of OncoArendi Therapeutics. “We are particularly excited about the potential of arginase as an additional new target in cancer immunotherapy and the potential of OATD-02 to become the best-in-class arginase inhibitor on the market. This compound demonstrated a potent extracellular and cellular activity while its pharmacological profile makes it suitable for oral dosing.”

Formal pre-clinical development of OATD-02 will be initiated next month with GLP toxicology studies expected in Q4 of this year and first in human studies anticipated in the third quarter of 2018. OncoArendi Therapeutics’ arginase inhibitors, including OATD-02, are protected by two pending patents covering two structurally different groups of compounds.


About Arginase Science
Arginase has been recently validated as a promising target in immuno-oncology. Arginase is an enzyme that catalyzes the final step in the urea cycle, during which the body disposes of harmful ammonia. However, in cancer, arginase through its capacity to decrease arginine levels, blocks the natural antitumor immunity by suppressing activation and proliferation of T cells. Even a moderate decrease of arginine levels is immunosuppressive. T-cells deprived of arginine do not die – they retain the ability to expand when arginine is replenished. Since the majority of human cancers exhibit a highly increased arginase activity and decreased plasma arginine levels, arginase inhibitors are expected to exhibit a wide clinical utility, in particular in combinations with other therapeutic modalities, such as checkpoints inhibitors and immunogenic therapies.
With a decade-long expertise in the type of chemistry required to synthesize and optimize arginase inhibitors, promising initial data and a strong development team, OncoArendi has laid out a clear strategy to bring to the clinic the best in class arginase inhibitor.

About OncoArendi Therapeutics
OncoArendi Therapeutics SA is an innovative biopharmaceutical company based in Poland, focused exclusively on discovery and development of small molecules to treat patients with unmet medical needs in cancer and respiratory diseases. It currently employs 70 people, the majority of whom hold PhD degrees in biology and chemistry and has raised over 35 million USD to support the progression of four distinct new chemical entities at various stages of development to Phase II clinical trials.

OncoArendi has been developing arginase inhibitors for the past three years and has selected OATD-02 out of the in-house library of over 200 compounds obtained through rational drug design. OncoArendi continues to develop inhibitors against other undisclosed targets in cancer metabolism.

OncoArendi also has broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs directed against different chitinase family targets. Its first clinical candidate OATD-01 is positioned to enter first-in-human Phase I clinical trial this fall. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases such as asthma, idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) and sarcoidosis, as well as fibrotic diseases of other organs and some types of cancer.
Contacts

Nicolas Beuzen
Business Development Director
n.beuzen “at” oncoarendi.com

Marcin Szumowski
President & CEO
m.szumowski “at” oncoarendi.com

OncoArendi Therapeutics S.A.
Zwirki i Wigury 101
02-089 Warsaw
Poland

 

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OncoArendi raises 4.5 mln USD (18 million PLN) in an extension of Series A financing round

As a part of the extension of Series A financing round, OncoArendi Therapeutics S.A. has raised 4.5 mln USD (18 million PLN) for continued development of its small molecule drug discovery programs for treatment of cancer and respiratory diseases. These funds, significantly complemented by the grant funding received from the Natioal Center for Research and Development (NCBR) as well as the European Commission (Horizon2020) will enable the company to progress its four key assets up to Phase II clinical trials for the following indications: cancer (lung, colon, gliaoblastoma multiforme or mylenoma), asthma, idiopathic pulmonary fibrosis or chronic obstructive pulmonary disease. The recent equity financing round sparked high interest from institutional and individual private investors.
meatnetadmOncoArendi raises 4.5 mln USD (18 million PLN) in an extension of Series A financing round
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OncoArendi receives the President’s Economic Award as the best Polish R&D Company in 2016

OncoArendi receives the President’s Economic Award as the best Polish R&D Company in 2016

During the Economic Congress in Rzeszów, OncoArendi Therapeutics has been recognized by the President of the Republic of Poland as the best Polish Company
of 2016 in the R&D category. During the evening gala ceremony attended by over 2000 participants President Andrzej Duda has personally congratulated the laureates of the
XIV edition of the Economic Award of the President of the Republic of Poland in six different categories.

Read More (in Polish) 


(fot. Krzysztof Sitkowski / KPRP)

meatnetadmOncoArendi receives the President’s Economic Award as the best Polish R&D Company in 2016
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OncoArendi Therapeutics has entered into a global license agreement with Yale University

acquiring exclusive rights to develop and commercialize a technology entitled “Inhibitors of Acidic Mammalian Chitinase (AMCase)”. Inhibitors of AMCase have been developed based on earlier discoveries of Jack A. Elias, MD, currently Dean of Medicine and Biologic Sciences and Frank L. Day Professor of Biology at Brown University. The results of his pioneering research at Yale (Science, 2004) showed that AMCase is induced during a Th2-mediated response in a mouse model of allergic airway inflammation. The relevance of these findings to the disease was also highlighted by the exaggerated expression of AMCase in human asthma.
OncoArendi Therapeutics in a project co-financed from the European Funds under the Innovative Economy Operational Programme has progressed the earlier work to show in vivo efficacy of AMCase Inhibitors in two different animal models of human asthma. Having secured over $3M in public and private funding for continuing this work, OncoArendi Therapeutics plans to identify a development candidate within the next 6 months and progress its development to IND submission and Phase I clinical trials by early 2017. In its research and development activities OncoArendi continues to collaborate with the groups of Prof. Jack A. Elias at Brown University and of Prof. Jakub Golab at the Medical University of Warsaw.
meatnetadmOncoArendi Therapeutics has entered into a global license agreement with Yale University
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Michał Sołowow invested in OncoArendi Therapeutics Sp. z o.o.

 On January 15, 2015 Michał Sołowow invested in OncoArendi Therapeutics Sp. z o.o. via  the IPOPEMA 112 FIZAN fund.

OncoArendi is a dynamically growing biotechnological company, which develops innovative anti-inflammatory and antitumor drugs with unique mechanisms of actions. Twelve million PLN obtained from Series A investors, with Michał Sołowow as leading investor, will allow the company to work on its key programmes for the next three years: potential asthma therapy and a group of new compounds stimulating the anti-tumour response of the human immune system. About 4 million Poles and 300 million people worldwide suffer from asthma with more and more children developing the disease. Currently used steroid therapies have severe side effects. At the same time every year cancer is diagnosed in more than 14 million patients and it remains the most frequent cause of death worldwide. In Poland both cancer incidents and death rate are the highest among European Union countries.
Apart from the company’s unique research programs and world leading position in the area of inhibitors of proteins called chitinases, investors were attracted to OncoArendi by its team of top medicinal chemists with many years of experience in pharmaceutical and biotechnology companies in the US, outstanding molecular biologists and successful managers with experience leading high-technology companies to IPO. Crucial for the investors was also The financial support, which the Company received from NCBR, was also important for investors, because it significantly lowers the risk of long term investment in scientific research.
OncoArendi is the first biotech investment for Michał Sołowow. This  sector still developing in Poland. Financing research aimed at developing innovative drugs is very risky, but if successful, the potential return on investment may be great. Acquisitions of New drug candidates, which have already entered clinical trials, may be acquired by global pharmaceutical companies for hundreds of  millions of dollars.
Investors and OncoArendi have joined forces to deliver to patients more effective and safer drugs than presently available therapies, along with company growth and substantial economic return.

meatnetadmMichał Sołowow invested in OncoArendi Therapeutics Sp. z o.o.
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Oncoarendi Therapeutics won over 25.5 million zloty

Oncoarendi Therapeutics as the leader of an academic – industrial consortium won over 25.5 million zloty in the second call for proposals of the National Center of Research and Development in the StrategMed program.
The aim of this project is to develop a conceptually novel therapeutic approach in cancer treatment – small molecule immune-modulators to knock-down the ability of tumors to escape immune surveillance.
The project was ranked second among twelve proposals recommended for funding and a total of one hundred and nine evaluated project proposals.

The consortium partners include Medical University of Warsaw, Nencki Institute of Experimental Biology, Institute of Biochemistry and Biophysics, International Institute of Molecular and Cell Biology, commercial partners – Nanovelos Ltd, Scanmed Hospital of St. Rafael, as well as subcontractors – Military Institute of Medicine, Oxford University, Weatherall Institute of Molecular Medicine.

   

meatnetadmOncoarendi Therapeutics won over 25.5 million zloty
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OncoArendi receives a grant of over 7 mln PLN for its lead drug discovery program

 OncoArendi will benefit from over 7 M in public financing within the Innovative Economy Operational Program, Action 1.4: “Support for targeted research projects”. The project, entitled “Selective inhibitors of acidic mammalian chitinase (AMCase) as potential therapy for asthma” will be executed in collaboration with several scientific and commercial contractors, including, among others, Medical University of Warsaw, Brown University, USA, Institute of Biophysics and Biochemistry and the Nencki Institute of Experimental Biology, Polish Academy of Science, the International Institute of Molecular and Cell Biology as well as a synthetic chemistry CRO – TriMen Chemicals SA. The project will result in identification of a clinical candidate to be registered as an investigational new drug for clinical trials.

 

meatnetadmOncoArendi receives a grant of over 7 mln PLN for its lead drug discovery program
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