French-based biotechnology firm Transgene has started dosing patients in the Phase II stage of the METROmaJX clinical trial of Pexa-Vec and metronomic cyclophosphamide combination for the treatment of advanced solid tumours such as breast cancer and soft tissue sarcoma (STS).
Developed by Transgene in collaboration with SillaJen, Pexa-Vec is a GM-CSF expressing vaccinia-derived oncolytic virus.
It is being developed to kill cancer cells, decrease the blood supply to tumours and trigger body's immune response against the tumour cells, while cyclophosphamide is a chemotherapy that will be administered in metronomic low doses at a higher frequency.
Pexa-Vec and cyclophosphamide are combined to target two different steps in immune response against tumour cells.
The Phase I/II METROmaJX trial is designed to assess the tolerability and efficacy of the combination therapy.
The investigator-initiated, open-label Phase II part of the trial will evaluate the anti-tumour efficacy of the combination in STS and HER2 negative-breast cancer patients.
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Supported by French National Cancer Institute (INCa), the trail is being conducted at the Institut Bergonié in Bordeaux.
Transgene chief medical officer Maud Brandely said: “We hope that the Phase II part of the study will demonstrate that this novel oncolytic virus plus chemotherapy regimen can be synergistic resulting in a high response rate, which could translate into improved overall survival.
"Advanced breast cancer and soft tissue sarcoma are two diseases which clearly require better treatment options for the patients.”
The results from Phase I stage of the trial indicated that the combination of Pexa-Vec and low-dose cyclophosphamide has an encouraging tolerability profile.