French biopharmaceutical firm Transgene is planning to start a Phase Ib/II trial with Pexa-Vec for the treatment of advanced solid tumours.

The study will be funded by the Institut National du Cancer (INCa) under a programme called CLIP, which facilitates patient access to new treatments and promotes global exchanges in cutting-edge research that involve academic-initiated research and novel therapies being developed by biotechnology and pharmaceutical companies.

Under the trial, Pexa-Vec will be evaluated in combination with metronomic cyclophosphamide, a drug used in combination with other therapies to treat variety of cancers.

Sponsored by Bergonié Institute (Bordeaux, France), the Phase Ib/II study is scheduled to be started later this year.

Transgene chairman and chief executive officer Philippe Archinard said: "It is noteworthy that Transgene will be one of the first biotechnology companies to have a trial funded by INCa."

"This trial complements the development plan we are finalising with our partners, which is expected to include a global Phase 3 trial in advanced liver cancer, as well as exploratory and supportive Phase 2 studies in a variety of cancer types and with various other therapies.

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"Pexa-Vec is armed with a GM-CSF gene that promotes an anti-tumour immune response."

"We look forward to providing soon a more comprehensive update on our plans for Pexa-Vec once our partner SillaJen’s acquisition of Jennerex has closed."

An engineered oncolytic vaccinia virus, Pexa-Vec (JX594/TG6006) is armed with a GM-CSF gene that promotes an anti-tumour immune response.

It is designed to selectively target and destroy cancer cells via three different mechanisms of action, including the lysis (breakdown) of cancer cells through viral replication, the reduction of the blood supply to tumours through vascular targeting and disruption, and the stimulation of the body’s immune response against cancer cells.

The company said that clinical trials are ongoing or planned in hepatocellular carcinoma (liver cancer), renal cell carcinoma (kidney cancer), colorectal cancer, as well as other tumour types.

In Europe, the Commonwealth of Independent States and the Middle East, the company has exclusive rights to develop and commercialise Pexa-Vec for the treatment of solid tumours.

Image: The US FDA and the European Medicines Agency have granted orphan drug designation for Pexa-Vec for hepatocellular carcinoma. Photo: courtesy of