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news.Onxeo announced its plan for further development of AsiDNA, its first-in-class signal interfering DNA molecule which breaks the cycle of tumor DNA repair to induce cancer cell death.
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In March 2016, Onxeo successfully completed the acquisition of DNA Therapeutics for its key innovative DNA repair inhibitor technology platform and lead compound AsiDNA.
Following the acquisition, Onxeo has strategically assessed development options and is now accelerating a deep and comprehensive advancement plan for its newest compound both as monotherapy and in combination with anti-cancer agents.
AsiDNA: first-in-class signal interfering DNA repair compound with blockbuster potential
Onxeo’s signal-interfering DNA (siDNA) product candidate, AsiDNA, 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[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 radiotherapy alone[6].
Development plan focused on systemic route administration
Preclinical: Based on these first local positive results as well as promising preclinical experiment outcomes, Onxeo is initating the development of AsiDNA through a systemic administration, enabling its potential as a therapy across a broad range of oncology indications. Preclinical programs have been initiated to further define the pharmacokinetic/pharmacodynamic profile following an intravenous administration. Results are expected in Q3/Q4 2016.
Manufacturing: In parallel, the Company is collaborating with one of the top U.S. manufacturing expert facilities for complex life science products, in order to optimize the manufacturing process of AsiDNA. Overall, the goal is to improve costs and production duration for future large-scale clinical development and industrialization. First results for this process development are expected in Q4 2016.
Clinical: Based on the already deep knowledge generated and the study outcomes set forth above, Onxeo is exploring opportunities to accelerate the clinical development of AsiDNA and is planning to launch the Company’s first clinical trial of AsiDNA as soon as 2017 to assess safety and first indication of anti-cancer activity of AsiDNA as monotherapy via systemic administration.
Judith Greciet, CEO of Onxeo, commented, "We have built an ambitious plan for AsiDNA to demonstrate its value in several types of cancer through a systemic administration. This plan aims at accelerating development with presentation of preclinical data within the next 6 months and a view to entering the clinic shortly therafter. First clinical data of AsiDNA in systemic use represent a major step in our development strategy as these results have the ability to confirm the tremendous potential of the product.
"Signal interfering DNA repair technology is increasingly becoming one of the most innovative research fields and such data, as soon as 2017, could support sound value creation for AsiDNA, for patients and for Onxeo as a company."