OncoArendi Therapeutics at the 2019 BIO International Convention in USA

From June 3 to 6, 2019, OncoArendi Therapeutics will present and promote its programs during the 2019 BIO International Convention in Philadelphia, USA, recognized as one of the world’s most important events in the biotechnology and pharmaceutical industry. Over 16,000 participants from 67 countries will attend the conference.

OncoArendi represented by: Marcin Szumowski, CEO, Nicolas Beuzen, Director of Business Development and Pawel Dobrzanski, Senior Scientific Director has over 40 formally accepted meetings, during which two of the Company’s most advanced assets will be presented:

  • OATD-01, a drug developed in inflammation-driven fibrotic diseases currently completing phase Ib of clinical development, as well as
  • OATD-02, an arginase inhibitor for cancer treatment, currently completing IND-enabling studies.

– During this event we will meet new prospects potentially interested in global or regional (i.e. Asian) rights, and continue ongoing discussions, initiated at previous events, some already under confidentiality agreements. At the same time scouting will be conducted to identify novel molecules that could complement our portfolio of early stage programssays Marcin Szumowski, CEO OncoArendi Therapeutics.

We are keeping our eye on the global biotechnology market that grows at an increasing pace. Many new innovative ideas appear in areas directly related to research projects currently pursued by OncoArendi. Inhibitors of deubiquitinases, a family of proteins representing potential targets in cancer therapy is just one example. These targets have been recently pursued by several mid-size biotech companies, confirming the attractiveness of these new molecular targets in treatment of various diseases.

More information about the 2019 BIO International Convention at: https://convention.bio.org/2019/

Magda KućmaOncoArendi Therapeutics at the 2019 BIO International Convention in USA
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OncoArendi at the conference “WSE Innovation Day”

We welcome you to the presentation of OncoArendi Therapeutics, which will take place on April 2, 2019 at the “WSE Innovation Day” conference

“WSE Innovation Day” is a free conference, during which representatives of companies from the new technologies, games or biotechnology sectors will meet with institutional investors, while at the same time meeting with individual investors. The organizers of this year’s edition of the conference are the Warsaw Stock Exchange and Vestor Dom Maklerski.

Details of the conference can be found at https://bit.ly/2HvnZ7L

The conference will be held at the head office of the Warsaw Stock Exchange, ul. Książęca 4.

Admission to the event is free, but requires registration.

Registration form: https://www.gpw.pl/innovationday

 

Magda KućmaOncoArendi at the conference “WSE Innovation Day”
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OncoArendi Therapeutics wins the award of the Stock Exchange “Company of the Year” competition 2018

In the ranking of the Listed Company of the Year, organized by Puls Biznesu and Bankier.pl, OncoArendi Therapeutics took second place in the category “Innovation in products and services”.

“We are pleased with the distinction and recognition by the capital market of OncoArendi Therapeutics’ innovative research and development of new drugs. This is a great success for a company which has been listed on the stock exchange for less than a year, and yet has overtaken many larger companies in the ranking, with much longer stock exchange experience. This is the reward of the whole OncoArendi team, whose passion and commitment and daily, hard work brings us closer to the goal set “- says Marcin Szumowski, president and significant shareholder of OncoArendi Therapeutics.

The ranking was based on surveys sent to nearly 100 analysts, managers and brokers, who selected and evaluated the best companies listed on the Warsaw Stock Exchange on five categories: board competence, investor relations, success in 2018, development prospects and innovation of products and services.

In the overall ranking, OncoArendi Therapeutics has been ranked 21st out of the top 30 rated companies from the WSE main market.

Information on the ranking on the website: https://www.pb.pl/gsr/o-rankingu

Magda KućmaOncoArendi Therapeutics wins the award of the Stock Exchange “Company of the Year” competition 2018
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Clinical trials of the OATD-01 molecule will enter the next phase

OncoArendi Therapeutics S.A., an innovative biotechnology company specializing in the quest, development and commercialization of new drugs used in the treatment of inflammatory and cancer diseases, on January 9 2019 received from the German National Institute for Medicines and Medical Devices (BfArM) permission to conduct a 1b phase of clinical trial for the OATD-01 compound.

The phase 1a clinical trials of the OATD-01 molecule, which was first given to humans (First-in Human), were successfully completed last year. The tests were conducted at a specialized center in Germany.

The permission to conduct the study was forwarded by BfArM to the Bavarian Ethics Committee, from which OncoArendi Therapeutics now expects a separate authorization to start phase 1b clinical trials.

We expect that, with the admission from BfArM, the decision of the Ethics Committee will be positive and we will be able to initiate study soon. Phase 1b clinical trials of the OATD-01 molecule will involve repeated administration of increasing doses to healthy volunteers to confirm its safety and lack of significant side effects.  The study will be carried out in Germany in the same center where we carried out phase 1a study. Our goal is to complete and summarize the results of Phase 1b research at the turn of the second and third quarter of 2019says Marcin Szumowski, president and significant shareholder of OncoArendi Therapeutics.

After successful completion of phase 1b for the OATD-01, the next phase of clinical trials is the phase 2 – the administration of the molecule to patients.Its initiation is possible this year. At this stage, we would be in a good position to start project commercialization, i.e. to sign a partnership agreement with a large pharmaceutical company. It is possible, however, that in order to increase project value project, we will decide to sign the license agreement at the time when we have test results confirming the initial therapeutic effect in patients, because it will increase the value of the programsays Marcin Szumowski.

OATD-01 is a new, non-steroidal drug developed by OncoArendi Therapeutics to treat asthma, sarcoidosis and spontaneous pulmonary fibrosis.

Potential therapeutic applications of OATD-01 are rare diseases that are unmet medical needs in the world, such as sarcoidosis and idiopathic pulmonary fibrosis, as well as selected groups of patients suffering from steroid-resistant bronchial asthma. The OATD-01 compound can inhibit the inflammatory process in the airways and the process of tissue changes leading to their fibrosis. Thanks to this, it can be a chance for treatment for those patients in whom previous therapies have been ineffective or for which drugs have not been developed so far.

More details are available from:

PR contact:

Michał Wierzchowski, cc group

phone +48 531 613 067

e-mail: michal.wierzchowski@ccgroup.pl **

Contact for investors:

Katarzyna Mucha, cc group

tel. +48 697 613 712

e-mail: katarzyna.mucha@ccgroup.pl

 

Magda KućmaClinical trials of the OATD-01 molecule will enter the next phase
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Submission of the application for the approval to initiate Phase 1b clinical trial for OATD-01

On October 30, 2018, OncoArendi Therapeutics has requested the German State Institute for Medicines and Medical Devices [BfArM] to start a phase 1b clinical trial for the OATD-01 compound, which will consist of repeated administration of the candidate drug to healthy volunteers in order to evaluate the safety and pharmacokinetics of the compound.

The transition to phase 1b is the next planned step of  OATD-01 compound development. The previous part of clinical trials – phase 1a was finally completed in September 2018.

Phase 1b involves safety and tolerability study of the drug administered repeatedly to healthy volunteers in order to determine the range of acceptable doses that can be used in Phase II clinical trials.

Successful completion of the first phase will confirm the safety of the drug and the possibility of transition to the second phase of clinical trials with patients, with the aim of preliminary demonstration of the therapeutic efficacy of the drug candidate.

The company assumes that 36 healthy volunteers will take part in the entire phase 1b study and its predictable duration will be several months.

The clinical part (phase 1a and 1b) of the OATD-01 compound development is carried out as part of the project “Pre-clinical and clinical trials of the candidate for an innovative drug in the therapy of asthma and inflammatory bowel diseases” co-financed by the National Center for Research and Development under the Intelligent Development Operational Program 2014 -2020.

The initiation of the phase 1b clinical trial for the OATD-01 compound also requires the parallel approval of the Bavarian Ethics Committee. A proposal in this regard will be sent to this Ethical Committee today.

Magda KućmaSubmission of the application for the approval to initiate Phase 1b clinical trial for OATD-01
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OncoArendi Therapeutics Gets Listed

Warsaw, 18 December 2017

Press Release

 

OncoArendi Therapeutics Gets Listed

 

OncoArendi Therapeutics S.A., an innovative, clinical stage, biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics for cancer and respiratory diseases, has filed documents with the Financial Supervision Authority, initiating the process aiming for the initial public offering (IPO) of its shares on the Warsaw Stock Exchange’s regulated (parallel) market.

‘We have decided to issue shares in an initial public offering and have them listed on the Warsaw Stock exchange in order to raise funds needed for the execution of our ongoing research and development projects and for launching new drug discovery projects. Our strategic aim is to advance our projects to the commercialization stage sufficient for entering into a partnership agreement or for licensing the technologies and associated intellectual property to global pharmaceutical companies. I hope that we will be ready for the IPO in the first half of next year, but the final decision if and when the IPO takes place depends, among other things, on the condition of the capital market,’ says Marcin Szumowski, CEO, president of the Board and significant shareholder of OncoArendi Therapeutics S.A.

OncoArendi is discovering and developing small molecule drugs in two therapeutic areas. The first one is inflammation-induced diseases that lead to tissue remodelling and fibrosis, in particular in lungs and the respiratory system. OncoArendi has selected its first and most advanced clinical candidate, OATD-01, which has shown both anti-inflammatory and anti-fibrotic effects in animal models of respiratory diseases, with potential utility in treatment of asthma, idiopathic pulmonary fibrosis or sarcoidosis. After OATD-01 has successfully completed preclinical development, last September OncoArendi received the approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate clinical trials. On October 11, the first group of healthy volunteers was administered OATD-01 as part of the first-in-human clinical trial conducted at a German contract research organization specializing in early stage clinical trials.

‘The first administration of OATD-01 in healthy volunteers is a major milestone in the development of a completely new class of medicines. We believe that inhibitors of the chitinase family of proteins have huge potential to become new medicines for the treatment of chronic respiratory diseases. The first administration of OATD-01 in human is also a big milestone in the development of OncoArendi Therapeutics, which is the third company in the history of the Polish biopharmaceutical sector to have initiated clinical development of an innovative drug.’ says Stanisław Pikul, a co-founder and VP of Development.

Another therapeutic area pursued by OncoArendi is oncology. The Company is working on the development of a new cancer immunotherapy, which is a new therapeutic approach with the greatest market potential. OncoArendi’s most advanced molecule is OATD-02, derived from over 200 new arginase inhibitors, which is expected to improve efficacy when used in combination with other therapies for the treatment of patients with colon, lung, skin or even brain cancer.  OATD-02, OncoArendi’s second clinical candidate, was selected in June 2017, and is now in pre-clinical development phase.

OATD-02 is an inhibitor of arginase enzymes, which block natural ability of the human immune system to fight cancer cells. The efficacy of OATD-02 in animal models of cancer is very promising, as we have demonstrated an increased therapeutic effect of the compound in combination with other medications that are already marketed. We are on track to start clinical trials in patients in early 2019.’ says Karolina Dzwonek, OncoArendi Therapeutics VP of Biology.

OncoArendi is also working on several other molecules. The third most advanced program involves selective inhibitors of CHIT1 protein, which could be used for treatment of rare respiratory diseases such as idiopathic pulmonary fibrosis or sarcoidosis. Another program discovering compounds inhibiting YKL-40 chitinase-like-protein has been launched in 2017. These inhibitors have significant potential in the treatment of various types of cancer, in particular glioblastoma multiforme.

For the advancement of the ongoing research projects, OncoArendi has raised funds from private investors and from numerous competitive grants, co-financed from the national funds, the EU funds, the Horizon 2020 programme and the US National Institute of Health (NIH).  The investors, who have believed in OncoArendi’s potential and its ability to develop and commercialize new medicines for respiratory and cancer diseases, include Michał Sołowow.

***

About OncoArendi Therapeutics:

OncoArendi Therapeutics S.A. is an innovative biotechnology company focused on discovering, developing and commercializing new drugs used in the treatment of cancer and respiratory diseases. OncoArendi’s research and development department currently employs nearly 60 researchers, more than half of whom hold a PhD degree.

OncoArendi Therapeutics is focused on discovering and developing molecules with potential to become first-in-class or best-in-class drugs worldwide to treat unmet medical needs. Concentration on first-in-class or best-in-class molecules significantly increases their value and market potential and enhances the probability of achieving a status of a leading therapy compared to competitive solutions.

OncoArendi’s business model is strictly focused on drug discovery and development, with its core strength in high quality medicinal chemistry and preclinical biology, enhanced by scientific collaborations with the key opinion leaders in specific disease areas and prudent use of CROs.

More details: https://oncoarendi.com/pl/o-firmie/

 

More details are available from:

PR contact:

Michał Wierzchowski, cc group

phone +48 531 613 067

e-mail: michal.wierzchowski@ccgroup.pl

This material is intended for promotional purposes only, and should in not be used for decisions on investment and purchase of shares issued by OncoArendi Therapeutics S.A. (‘the Company’). The Prospectus, prepared for offering the Company’s securities to the public in Poland as well as having them admitted to trading on the Warsaw Stock Exchange’s (WSE’s) regulated market, will be the only legally binding document to contain information about the Company and its initial public offering of securities in Poland (‘Offer’). The Company will be able to conduct the Offer in Poland once the Prospectus has been approved by the Financial Supervision Authority and published. Published in connection with the Offer in Poland and the Company’s securities being admitted to trading on the Warsaw Stock Exchange, the Prospectus will be available from the Company’s website (http://www.oncoarendi.com/pl/) and that of the Offering Party, Trigon Dom Maklerski S.A. (http://www.trigon.pl/).

Dissemination of this document may be prohibited in some countries. It is forbidden to distribute this document in Canada, Japan and Australia. The information contained in the attached document does not constitute a sales offer or an invitation to bids for the purchase of the securities in Canada, Japan or Australia.

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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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