Onxeo Receives U.S. Patent and Trademark Office Notice of Allowance for New Patent Protecting Combination of AsiDNA™ with Any PARP Inhibitor for Cancer Treatment

Regulatory News:

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo” or "the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO), granting the Company a new patent covering the combination of AsiDNA™, Onxeo’s first-in-class DDR inhibitor, with any PARP inhibitor (PARPi) for cancer treatment, in the United States.

Onxeo was granted a corresponding patent in Europe in December 2018. The new U.S. patent, is valid until 2036. It further expands Onxeo’s intellectual property portfolio for AsiDNA™, which now includes 168 number of patents globally.

"Cancer therapeutic resistance is one of the most significant challenges for successful treatment. Therefore, fighting acquired resistance has become a key focus for researchers and clinicians around the world. Our translational studies of AsiDNA™ have demonstrated its significant potential in combating cancer therapeutic resistance to both DNA-damaging agents and targeted therapies such as PARPi. This new patent, which expands the protection of the combination of AsiDNA™ with any PARP inhibitor to the leading U.S. market, further supports the initiation of a new clinical study in the coming months that is designed to validate this very unique effect of AsiDNA™ on the acquired resistance to a PARPi," said Judith Greciet, Chief Executive Officer of Onxeo.

Onxeo has conducted an extensive preclinical program with AsiDNA™ in combination with various PARPi in several cancer models, such as triple negative breast cancer and small-cell lung cancer. In addition to demonstrating the strong synergistic effect of the combination, even in cancer cells non-sensitive to PARPi alone, the translational studies have shown the ability of AsiDNA™ to prevent the onset of tumor resistance to PARPi and even abrogate an acquired resistance. This property will be further evaluated in the upcoming Phase 1b clinical study of AsiDNA™ in combination with a PARP inhibitor in advanced ovary cancer.

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About Onxeo

Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.

platON™ is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company’s product pipeline.

AsiDNA™, the first compound from platON™, is a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a decoy and agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the distinctive properties of AsiDNA™, notably its ability to abrogate tumor resistance to PARP inhibitors regardless of the genetic mutation status. AsiDNA™ has also shown a strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study has evaluated AsiDNA™ by systemic administration (IV) in advanced solid tumors and confirmed the active doses as well as a favorable human safety profile. The ongoing DRIIV-1b extension study is assessing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin and then with carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.

OX401 is a new drug candidate from platON™, optimized to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. OX401 is undergoing preclinical proof-of-concept studies, alone and in combination with immunotherapies.

Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2^nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).

For further information, please visit www.onxeo.com.

Forward looking statements

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 section 5.7.1.4 "Risk Factors” ("Facteurs de Risque") of the 2018 registration document filed with the Autorité des marchés financiers on April 25, 2019 under number D.19-0282, which is available on the Autorité des marchés financiers website (www.amf-france.org) or on the Company’s website (www.onxeo.com).

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