The European Commission has allocated, through the H2020-EIC-SMEInst-2018-2020-Phase 2 program, a total of 1,085.659€ to the BERMES project of Aromics, the objective of which is to complete the regulatory pre-clinical stage in order to begin studies in humans of the drug NAX035 for malignant mesothelioma, an aggressive and highly resistant cancer linked to asbestos exposure.
- The European Commission has allocated, through the H2020-EIC-SMEInst-2018-2020-Phase 2 program, a total of 1,085.659€ to the BERMES project of Aromics, the objective of which is to complete the regulatory pre-clinical stage in order to begin studies in humans of the drug NAX035 for malignant mesothelioma, an aggressive and highly resistant cancer linked to asbestos exposure.
- NAX035 is a compost with a disruptive action mechanism: it is directed against messenger RNA, the messenger molecule between DNA and proteins.
- BERMES will have a duration of two and a half years and a budget of 1.55 M €, that the biotech will complement with the capital increase of 400,000 euros closed in 2017 and the participative loan of 120,000 euros allocated by the Institut Català de Finances through the IFEM program.
- The use of asbestos will be definitively banned in the European Union in 2005 (in Spain in 2002) but it is a tumour with a long latency period (30 to 40 years from the exposure to the diagnosis), for which a high increase in its incidence in Europe is expected from 2020. The European Economic and Social Committee estimates that more than 300,000 Europeans will die per mesothelioma by 2030.
Barrcelona, 14 February 2019. Aromics, a biotech company located at the Barcelona Science Park (PCB), has been awarded with 1,085.659€ from the European Union – through the SME instrument of the Horizon 2020 (H2020-EIC-SMEInst-2018-2020-Phase 2)– for the development of the BERMES project, whose objective is the completion of the regulatory preclinics of NAX035, an innovative therapy for the treatment of malignant mesothelioma, an aggressive and highly refractory tumor directly related to asbestos exposure.
BERMES, an acronym for “A novel derivative BERberine for Malignant MESothelioma”, started on first November 2018 has a duration of two and a half years and a total budget of 1.55 M €. The contribution from the European Union joins the capital of 400,000 euros already raised by the company in 2017 - with the participation of the current owners, corporative partners and also small investors that were incorporated through the crowdfunding biomedicine platform Capital Cells - and the participative loan of 120.000 € allocated by the Catalan Institute of Finance through the corporate entrepreneurship programme IFEM, which is supported by the Agency for Enterprise Competitiveness (ACC1Ó) under the program of grants in the form of a guarantee for the financing of companies participating in corporate entrepreneurship projects by means of co-investment loans (FINPEC).
Malignant mesothelioma is a tumour that emerges in the mesothelium, a thin layer of tissue that surrounds many organs such as the lung, peritoneal cavity, heart or testicles. It is an aggressive malignancy that is highly resistant to current therapies. “Patients with malignant pleural mesothelioma, the most common type, continue to have a poor prognosis, with a survival of less than 10% at five years after diagnosis. Available therapies include surgery combined with chemotherapy and radiotherapy. Most patients, however, are diagnosed in advanced stages of the disease, when chemotherapy is usually the treatment of choice. A chemotherapy with a low rate of response, despite the significant effort made over the last ten years to find a more effective treatment,” explains Dr. Carmen Plasencia, the co-founder and CEO of Aromics.
El This is the focus of the BERMES project, which seeks to develop a new cure for this devastating cancer, thus meeting an important medical need.
A public health problem not yet solved
The World Health Organization (WHO) has recognized that all forms of mesothelioma are strongly associated with asbestos exposure. Although recognized as a first-level carcinogen, asbestos is still being used daily in alarming quantities in more than 150 countries according to the International Ban Asbestos Secretariat (IBAS). In fact, the WHO estimates that more than 125 million people are daily at risk of exposure, of which approximately 10% will eventually develop mesothelioma.
“Asbestos still represent a great labour, environmental and public health problem that has not been solved. Even in those countries like EU countries where it is forbidden, this material still remain in many buildings and installations. Factors such as the high costs for the safe removal of elements that contain these mineral, increase the risk of appearance of these tumours,” assures Carme Plasencia.
The incidence of this cancer is increasing all over the world, being the countries of the European Union (EU) those that register the highest number of cases despite the use of asbestos was definitively prohibited on 1st January 2005 (Directive 1999/77/EC).
El Notwithstanding, the malignancy has a long latency period (a 44.6 year average from the exposure to the diagnosis) being the incidence peak expected from 2020 onwards. In fact, the European Economic and Social Committee (EESC) estimates that more than 300,000 Europeans will die of mesothelioma by 2030, at that time it is expected that the maximum number of diseases caused by exposure to asbestos will be observed.
A first-in-class drug
The NAX035 compound is one of the most advanced in the Aromics therapy portfolio. It is the first candidate molecule of a new family of antitumour agents (first-in-class) to advance up to the clinical stage.
“It is a pioneering drug, very attractive to the pharmaceutical industry. The Aromics molecule binds to a specific messenger RNA and reduces the levels of a protein that is abnormally expressed in the tumour, and that is causing resistance to current chemotherapy treatments in mesothelioma patients. In this way we aim to address the root cause, stopping the synthesis of this abnormal protein and therefore controlling the disease”, says Dr. Plasencia.
The drug has already demonstrated its effectiveness in reducing the tumour size when administered both, orally or intraperitoneally in experimental animal models, showing a good toxicological and safety profile. At the same time, the biotech is working to achieve the orphan designation for NAX035, which would represent an important milestone for the company.
“This project is a clear example of the company’s activity in the area of translational medicine that leads to a better understanding of the progression of the disease and the identification of specific molecular markers relevant to the treatment response, that allow us to develop more efficient therapeutic solutions for the treatment of complex pathologies such as cancer,” Dr. Plasencia says.
After completing BERMES project, Aromics’ objective is continuing with the development of the compound up to early clinical stage to prove the efficacy in patients. After the clinical proof of concept, the biotechnology foresees a licencing or co-development agreement on the product with the pharmaceutical industry that will be finally the one leading the development up to the market. Aromics is already in contact with some pharmaceutical companies that have shown interest in the drug.
n About Aromics
Applied Research using Omic Sciences S. L. (Aromics), founded in 2005 with its headquarters at the Barcelona Science Park, focuses its activity on the research and development of new therapies and diagnostic products for the treatment of human health related diseases.
The business model of the biotechnology company is oriented towards the development of its own drugs, from the earliest drug discovery and development process up to the earliest clinical stages, to the search for a licensing agreement after the first proof-of-concept in humans.
Since its inception, the company has mobilized close to 8.5 million euros coming from the investment of its own entrepreneurs and various public and private capital contributions.
For further information:
Azucena Berea • Press Officer • Barcelona Science Park• Tel. 93 403 46 62 • aberea@pcb.ub.cat
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the EIC-SMEInst-2018-2020 - SME Instrument phase 2 topic.
