DNA Therapeutics is a clinical stage French biopharmaceutical company focused on the development of 1st-in-class targeted drugs for sensitizing resistant cancer to conventional cancer therapy. It is based on an original concept of “signal interfering DNA” (siDNA) to jam DNA damage sensing and signaling – the upstream common step of all DNA repair pathways, thus inhibit efficiently DNA repair activities despite the redundancy of pathways.
In preclinical studies, Dbait combined with various cancer treatments such as radiotherapy and chemotherapy, showed better tumor growth control in a dose dependent manner, and complete cure at high dose without relapse in many tumor models. Dbait is also active as a standalone treatment in the tumors with genetic instability, a hallmark of all cancers at the advanced stage. In addition, tumor metastasis was delayed when treated by Dbait in several animal models. Predictive biomarkers of Dbait have been identified and under development.
DRIIM, the 1st-in-human trial of DT01 (the clinical form of Dbait) combined with palliative radiotherapy in patients suffering from metastatic melanoma has been carried out in France and shows (in 23 patients):
– Good local, systemic, and immune tolerance and safety of DT01
– Remarkable tumor response correlated with systemic exposure of DT01
These early clinical results consolidate the proof of concept of Dbait/DT01, and warrant further clinical development.
DRIIM trial results have been presented at the ASCO 2015 (on Saturday the 30th of May, poster #271, abstract #2555).
French Competent Authority (ANSM) and the local Ethic Committee (CPP) cleared the amendment of DRIIM trial for up to 2 additional doses.