Onxeo receives USPTO Notice of Allowance for key AsiDNA™ patent, extending IP protection in the U.S. until 2031

  • Products, including AsiDNA (signal interfering DNA), protected until 2031 with potential extension to 2036
  • Onxeo’s intellectual property for DNA repair signal interfering technology and products protected by 8 patent families worldwide

 Paris (France), Copenhagen (Denmark) Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), an innovative company specialized in the development of orphan oncology therapies, today announced it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) relating to a key patent for its signal interfering DNA product candidate, AsiDNA™.

This new patent significantly strengthens the Company’s AsiDNA intellectual property portfolio by protecting several conjugated nucleic acid molecules as well as AsiDNA’s pharmaceutical composition and related methods for treating cancer. The patent application was filed in October 2015 as a continuation of a first US application (now Pat. No. 9,205,099, granted in February 2016) and allowed today. This patent’s allowance, less than one year after its filing confirms the innovative science behind the technology of Signal Interfering DNA products. Corresponding patent applications have been already granted and/or are currently under examination notably in Europe, Australia, Canada, China, Israel, India and Japan.

The allowed patent has a term expiring in mid-2031, before a possible patent term adjustment (PTA). This term could be further extended to 2036 through the patent term extension (PTE).

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

Strengthening our intellectual property protection is a key  element of our ambitious development plan for AsiDNA and our ability to deliver on its full potential in a large number of indications. We are pleased that the USPTO issued this Notice of Allowance so quickly after the initial application was submitted, which we believe speaks to the unique and innovative nature of the technology,”  commented Judith Greciet, CEO of Onxeo.

Building a strong patent position in the US is an important part of our value-creation strategy across all of our product and platform candidates. The addition of this patent to the AsiDNA IP portfolio will significantly strengthen our position in the DNA repair market and protect our ability to continue developing this novel technology,” added Aude Michel, Head of Corporate Development at Onxeo also in charge of IP.

AsiDNA: a first-in-class DNA repair signal interfering product with blockbuster potential

Onxeo’s first-in-class signal-interfering (siDNA) product candidate, AsiDNA, is a short, double-stranded DNA molecule that  breaks the cycle of tumor DNA repair by interfering at the core of DNA damage, blocking multiple repair pathways, while sparing healthy cells. AsiDNA and its signal-interfering technology offer potential new treatment options for patients suffering from various types of cancer.

The technology has already demonstrated its ability to increase the efficacy of radiotherapy[1], radiofrequency ablation[2], and chemotherapy[3] in a variety of preclinical animal models, positioning it as a promising candidate for both mono- and combination therapy. A first-in-human Phase I trial[4] (DRIIM) for metastatic melanoma further demonstrated that AsiDNA therapy  showed strong tolerance and safety when administered intra-tumorally and subcutaneously around the tumors, with no evidence of inflammatory reaction. Results presented at ASCO 2015[5] showed, based on 23 patients, an objective response rate (ORR) of 59% and a complete response (CR) rate of 30% compared to 10% CR with low-dose radiotherapy alone[6].

[1] Quanz et al., 2009, Berthault et al., 2011, Coquery et al., 2012, Biau et al., 2014

[2] Devun et al., 2014

[3] Devun et al. 2011, Herath et al., 2016

[4] DRIIM Phase 1 trial, “DNA Repair Inhibitor & Irradiation on Melanoma” NCT01469455)

[5] Abstract available at http://meetinglibrary.asco.org/content/143029-156

[6] Based on literature data.