Date: 2017-07-05
Type of
information: Results
phase: preclinical
Announcement: results
Company: Onxeo (France)
Product: AsiDNA™
Action
mechanism:
- nucleotide/signal interfering DNA molecule/DNA break repair inhibitor. AsiDNA™ 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. The technology has already demonstrated its ability to increase the efficacy of radiotherapy , radiofrequency ablation , and chemotherapy in a variety of preclinical animal models. A first-in-human Phase I trial (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 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.
Disease:
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On July 5 2017, Onxeo announced positive preclinical proof of concept results confirming the activity via systemic (intravenous, IV) administration of AsiDNA™, the company’s first-in-class DNA repair inhibitor. A first phase I trial (DRIMM1) of AsiDNA™ via local administration in melanoma previously demonstrated good tolerance and a beneficial safety profile, as well as a strong signal of efficacy. The objective of these most recent preclinical studies was to show that AsiDNA™ is also effective when administered via an IV route, which would open a wide potential of tumor types for treatment with AsiDNA™.
- The generated data confirms the activity of AsiDNA™ administered intravenously, alone and in combination, as shown by the prevention of tumor growth in a murine model of triple negative breast cancer. These data also showed a significant synergistic effect of AsiDNA™ when combined with carboplatin. AsiDNA™ via IV administration is therefore an ideal candidate for monotherapy, as well as for combination therapy with genotoxic oncology treatments, such as radio or chemotherapy, or with other DNA repair inhibitors that target a single repair pathway, such as PARP inhibitors.
- Additionally, pharmacodynamics data generated supports AsiDNA™ unique mechanism of action whereby it acts as a decoy that attracts repair enzymes, breaks the cycle of tumor DNA repair activities and interferes with multiple repair pathways, whilst sparing healthy cells. The activity of AsiDNA™ via systemic injection was demonstrated to be related to its ability to sequester and hyperactivate two key DNA repair proteins, DNA-PK and PARP, thus preventing their recruitment at damage sites in tumor cells. Onxeo now intends to file the phase I trial submission dossier to regulatory authorities by the end of 2017.
Is
general: Yes
