Drug Candidate OATD-01 may find use in treatment of pulmonary fibrosis in patients who have survived a new coronavirus infection (COVID-19)

  • Potential effectiveness of OATD-01 in the treatment of pulmonary fibrosis is based on a unique mechanism of inhibiting a new biological target – chitotriosidase 1 (CHIT1)
  • Linking COVID-19 infection to pulmonary fibrosis where CHIT1 plays a role will increase the value of OATD-01 and other chitinase inhibitors for potential partners
Magda KućmaDrug Candidate OATD-01 may find use in treatment of pulmonary fibrosis in patients who have survived a new coronavirus infection (COVID-19)
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National Center for Research and Development (NCBR) funds OncoArendi Therapeutics’ new research platform of innovative anticancer drugs targeting deubiquitinase proteins.

A proposal submitted by OncoArendi Therapeutics in the Innovative Development Operational Programme (POIR) call for proposals for funding a research project – “RESEARCH AND DEVELOPMENT OF DEUBIQUITINASE INHIBITORS IN ANTITUMOR IMMUNOTHERAPY”, was recommended for funding in the official list published by the National Center for Research and Development (NCBR). The total budget of the project is approx. 31 million PLN, with the amount of funding over 22 million PLN.

Magda KućmaNational Center for Research and Development (NCBR) funds OncoArendi Therapeutics’ new research platform of innovative anticancer drugs targeting deubiquitinase proteins.
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New Head of Research (Chief Scientific Officer) at OncoArendi

OncoArendi has recently hired dr. Rafał Kamiński for the position of Chief Scientific Officer. He has acquired broad international experience in discovery and development of innovative small molecule drugs and management of scientific teams from previous work for global pharmaceutical companies. Immediately prior to accepting the CSO position at OncoArendi Therapeutics, dr. Kamiński worked for the Roche Group (Basel, Switzerland).

Magda KućmaNew Head of Research (Chief Scientific Officer) at OncoArendi
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First clinical proof-of-concept for arginase inhibitors in cancer immunotherapy

Data presented at the European Society of Medical Oncology (ESMO) in Barcelona by Calithera Biosciences, a biotechnology company from California, USA, add to a growing body of evidence indicating that arginase inhibitors could emerge as novel cancer immunotherapies.

A small molecule drug candidate (INCB001158), licensed by Calithera to Incyte Corporation, is the first arginase inhibitor currently in clinical development. On September 29th Calithera Biosciences presented results of a phase I clinical study of their small molecule drug candidate. In this safety and tolerability study, patients with metastatic or locally advanced cancers, not amendable to available therapies, were treated with INCB001158. Cancer types included lung cancer, colorectal cancer and other solid tumors. INCB1158 was well tolerated and inhibited plasma arginase activity, inducing increased plasma arginine levels at all doses tested.

Magda KućmaFirst clinical proof-of-concept for arginase inhibitors in cancer immunotherapy
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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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