PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)--Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced that Doctor Marie Dutreix has received the Lazorthes Prize, awarded by the prestigious French Academy of Sciences in Paris, for her research on the Dbait technology. AsiDNA™, a molecule derived directly from the Dbait concept, breaks the cycle of tumor DNA repair by inducing the accumulation of damage in the DNA and cell death in tumor cells, while sparing healthy cells.
Since acquiring the Dbait technology in February, Onxeo has initiated an ambitious development program in order to realize the strong potential of AsiDNA™ in monotherapy or in combination with other anti-cancer therapies. A first Phase I clinical trial in patients with metastatic melanoma demonstrated the good tolerance and safety of AsiDNA™ in intra-tumoral and subcutaneous administration combined with radiotherapy. This Phase I study also revealed some very promising signs of efficacy of the molecule used in combination with radiotherapy. Onxeo has decided to continue to develop this drug for systemic administration and evaluate the safety and level of tolerance, in monotherapy or in combination with other treatments, when used in various types of solid tumours. Therefore, a new Phase I clinical trial will begin in 2017 following regulatory toxicology tests.
At the same time, Onxeo has published the results of preclinical research studies in Clinical Cancer Research1, which demonstrate the synergistic effect of AsiDNA™ when combined with several products from the PARP (Poly ADP-Ribose Polymerase) inhibitor class. These new data have confirmed the advantages of AsiDNA™ compared to PARP inhibitors alone, as well as the benefits of combining the two DNA repair inhibitors.
Judith Greciet, CEO of Onxeo, said: "We are delighted that Dr. Dutreix has been recognised and rewarded by the members of the prestigious French Academy of Sciences for her research work in the domain of DNA repair, which generated the breakthrough innovative technology DBAIT and its first application AsiDNA™. Dr. Dutreix is still closely involved as a consultant in the development of AsiDNA™. This technology positions Onxeo at the forefront of medical research with a promising and innovative therapeutic approach for cancer patients, while providing strong value-creation for our shareholders".
1 - « Drug Driven Synthetic Lethality: bypassing tumor cell genetics with a combination of Dbait and PARP inhibitors », published the “Clinical Cancer Research” in September 2016.
AsiDNA is a signal interfering DNA repair pathway inhibitor being developed by Onxeo as an anti-cancer agent. As a short double-stranded DNA molecule, AsiDNA utilizes a unique mechanism of action to break the cycle of tumor DNA repair by interfering at the core of DNA damage, blocking multiple repair pathways, while sparing healthy cells. A first-in-human Phase I clinical trial evaluating AsiDNA in combination with radiotherapy for treatment of patients with metastatic melanoma showed AsiDNA is well tolerated and demonstrated proof of efficacy, with an objective response rate of 59% and a complete response rate of 30% compared to 10% CR with radiotherapy alone. Onxeo is currently accelerating a comprehensive advancement plan for AsiDNA as monotherapy and in combination with anti-cancer agents to offer potential new treatment options for patients suffering from various types of cancer.
Onxeo is a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry. Onxeo’s objective is to become a major international player in the field of rare cancers. Its growth strategy is founded on the development of innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in the treatment of orphan oncology diseases and considerably improve the quality of life of patients affected by rare and aggressive cancers. Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with four independent programs in various stages of clinical development, including Onxeo’s first approved orphan oncology drug, Beleodaq®. The Company is headquartered in Paris, France and has approximately 50 employees. Onxeo is listed on Euronext in Paris, France (Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark (Ticker: ONXEO).
Onxeo’s orphan oncology products are:
- Livatag® (Doxorubicin Transdrug™): Currently being evaluated in a Phase III trial (ReLive) in patients with hepatocellular carcinoma (primary liver cancer); and in combination with other cancer agents in first-line HCC
- Beleodaq® (belinostat): FDA-approved in the US in 2014 under the agency’s accelerated approval program as a second-line treatment for patients with peripheral T-cell lymphoma (PTCL) and currently marketed by Onxeo’s partner in the US, Spectrum Pharmaceuticals; belinostat in combination with other cancer agents is currently in development in first-line treatment for patients with PTCL (BelCHOP) and in other solid tumors
- AsiDNA: The first-in-class siDNA (signal-interfering DNA) which has successfully undergone a proof-of-concept Phase I trial in metastatic melanoma
- Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial in head and neck cancer patients with severe oral mucositis
In addition, Onxeo has successfully developed and registered two non-cancer products, which are currently being commercialized in the U.S. and Europe.
Learn more by visiting www.onxeo.com.
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This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2015 Reference Document filed with the AMF on April 29, 2016, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).