Onxeo encouraged by intermediate results from the first part of the DRIIV-1b study evaluating AsiDNA in combination with chemotherapy

Onxeo said it stabilized disease without tumor progression for two of the three treated patients who are still receiving treatment with AsiDNA™ plus carboplatin, with reaching satisfactory tolerance allowing the continuation of the study to evaluate AsiDNA™ in combination with carboplatin and paclitaxel, a reference treatment protocol for many cancers.

PARIS–(BUSINESS WIRE)–Regulatory News:

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO – FR0010095596), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, today announced positive results from the first group of patients in the DRIIV 1b study, evaluating AsiDNA™, first-in-class inhibitor of tumor DNA repair, in combination with chemotherapy and the start of the second part of the study to evaluate the combination of AsiDNA™ with carboplatin and paclitaxel in patients with solid metastasized tumors who are eligible for this treatment.

In this first part, three patients with metastatic cancer and eligible for carboplatin therapy (non-small cell lung cancer, triple negative breast cancer, gastric cancer), whose disease was progressing at the time of their inclusion in the study, were treated with the combination of a 600mg active dose of AsiDNA™ administered intravenously and a standard carboplatin administration protocol.

No dose-limiting toxicity (DLT) or severe adverse effect was observed in any of these three patients. The tolerance of the combination was considered good and led the independent committee of experts in charge of the monitoring of the study (DSMB) to recommend the continuation of the study aiming at evaluating AsiDNA™ in combination with carboplatin and paclitaxel, a reference protocol for many solid tumors such as lung, breast, ovary or head and neck cancers.

Two of the three treated patients show tumor control (stable disease demonstrated by medical imaging according to the RECIST solid tumor response assessment criteria) since the start of their treatment, i.e. for more than 4 and 5 months. As provided for in the protocol, treatment is continued until the tumor has progressed or in the event of an intolerance to carboplatin.

Olivier de Beaumont, Onxeo Medical Director, said: “We are very satisfied with these initial results. First, AsiDNA™ confirms its good tolerance profile, even in combination with chemotherapy, and also, two of the three patients treated are still assessed as stable, after almost 5 to 6 months of treatment.. These good results make possible the start the second part of the study to evaluate AsiDNA™ in combination with carboplatin and paclitaxel, a standard of treatment used for several solid tumors. Initial results on this combination are expected at the end of the year, and will represent a major proof of concept for AsiDNA™ in combination with chemotherapy.”

The combination of carboplatin, a platinum salt chemotherapy, and paclitaxel is considered a reference protocol treatment, which is widely used to treat many cancers, including breast cancer, ovarian cancer and lung cancer. However, a resumption of tumor progression is frequent, in the more or less short term, thus leaving patients with no therapeutic option.

AsiDNA™ is a first-in-class tumor DNA repair inhibitor that exhausts the repair pathways without causing resistance. Combined with its good tolerance, which is already clinically proven, this highly innovative mechanism of action makes it particularly well suited for combination with treatments such as chemotherapies including carboplatin, which causes DNA breaks. The combination of the two treatments could increase the effectiveness of chemotherapy alone, which is what DRIIV-1b aims to demonstrate.