Onxeo Strengthens AsiDNATM Patent Protection in Europe

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 having received communication from the European Patent Office (EPO) informing its intention to grant a new patent covering especially the particular nucleic acid molecule comprised within AsiDNA^TM, Onxeo’s first-in-class signal-interfering (siDNA) product candidate in the European countries.

"With the addition of this patent, AsiDNA^TM’s patent family will include 8 complementary patents worldwide, increasing the drugs patent protection further. The grant is another step in bringing AsiDNA^TM to the patients in need and we look forward to initiating the Phase I study, which is planned for 2017,” said Judith Greciet, CEO of Onxeo.

This new patent will considerably strengthen the industrial property around AsiDNA^TM, by protecting the particular double-stranded DNA molecule of the drug. By covering any products conjugated or including said DNA molecule, this new patent protects AsiDNA^TM as such but also derivatives thereof sharing the same DNA sequence.

The IP estate related to AsiDNA^TM consists of eight worldwide patent families, covering its technology platform, its products conjugated or not, and their therapeutic utilization as a monotherapy or in combination with radiotherapy, hyperthermia or chemotherapy as well as their method of administration and the potential biomarkers predicting the response to a therapy with AsiDNA^TM and/or other related products offering a protection on the product AsiDNA^TM as such until 2031.

About AsiDNA
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.

About Onxeo
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); Livatag is also under exploratory preclinical development to assess interest of its combination with other anti cancer agents.
• 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 a oral formulation is under development.
• AsiDNA: first-in-class siDNA (signal-interfering DNA) which has successfully undergone a proof-of-concept Phase I trial in metastatic melanoma via local administration
• 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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Disclaimer
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).

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