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Clinical Trials

Date: 2017-09-28

Type of information: Interim results

phase: preclinical

Announcement: interim results

Company: Onxeo (France)

Product: AsiDNA™ and belinostat

Action mechanism:

  • nucleotide/signal interfering DNA molecule/DNA break repair inhibitor/histone deacetylase inhibitorAsiDNA™ is a signal-interfering DNA (siDNA) product candidate. This short, double-stranded DNA molecule breaks the cycle of tumor DNA repair by interfering at the core of DNA damage, blocking multiple repair pathways, while sparing healthy cells.
  • In March 2016, Onxeo successfully completed the acquisition of DNA Therapeutics for its key innovative DNA repair inhibitor technology platform and lead compound AsiDNA. This first-in-class signal interfering DNA repair compound is a short double-stranded DNA molecule which breaks the cycle of tumor DNA repair by interfering at the core of DNA damages, 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. This technology has already demonstrated an increase in the efficacy of radiotherapy , radiofrequency ablation , and chemotherapy in a variety of preclinical animal models, making it a promising candidate for both mono and combination therapy.
  • A first-in-human Phase I/IIa trial (DRIIM) performed in metastatic melanoma further demonstrated that AsiDNA molecules showed good tolerance and safety when administered intra-tumorally and subcutaneously around the tumors, with no evidence of inflammatory phenomena. Results presented at ASCO 2015 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 radiotherapy alone.
  • Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.
  • Beleodaq® (belinostat) has received accelerated approval by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma in July 2014.

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

  • • On September 28, 2017, Onxeo announced compelling results from extensive in-vitro preclinical studies of combinations of AsiDNA™ a first-in-class DNA break repair inhibitor (DBRi) with histone deacetylase inhibitor (HDACi), including belinostat, on various tumor cell lines. These data and potential future applications have been fully protected by a patent application  covering the use of AsiDNA™ in combination with any HDAC inhibitor in any treatment scheme. Based on scientific evidence that HDAC inhibitors increase two-strand DNA breaks in tumor cells, the company has performed combination experiments demonstrating the synergistic effect of the association of AsiDNA™, its first-in-class DBRi, with HDAC inhibitors, including with belinostat.

Is general: Yes