On October 17, 2018 Transgene (Paris: TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops viral vector-based immunotherapies, reported the treatment of the first patient in the TG6002 Phase 1/2 trial in patients with advanced gastrointestinal tumors such as colon cancer, in the Léon Bérard center (Lyon) (Press release, Transgene, OCT 17, 2018, View Source [SID1234529952]). This multicenter trial is authorized in France, Belgium and Spain. It will include up to 59 patients.

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TG6002 is a new generation multi-functional oncolytic virus that can be administered intravenously and combines several mechanisms of action . It was designed to combine the mechanism of oncolysis (destruction of the cancer cell) with local production of chemotherapy (5-FU), directly into the tumor. Induction of an immune response against tumor cells is another expected effect. TG6002 expresses the patented FCU1 gene in tumor cells that it has infected, leading to the local conversion of 5-FC (administered orally) to 5-FU. This is particularly important because of the sensitivity of most gastrointestinal tumors to 5-FU.

TG6002 has demonstrated in preclinical its ability to induce a response in the primary tumor as well as a distant effect on metastases by causing immunogenic cell death.

Dr. Philippe Cassier, PhD, principal investigator of the trial and head of the early phase trial unit at the Léon Bérard Center, explains: "Despite the improved prognosis of patients over the last 20 years, the median survival of metastatic colorectal cancer (CRC) patients remains below three years. Patients receive up to four successive treatment lines, which can be associated with significant side effects. In addition, the majority of these do not respond to immune checkpoint inhibitors. For this reason, 5-FU-based chemotherapy remains the standard treatment for this disease. TG6002, an oncolytic virus that destroys cancer cells and produces 5-FU at the heart of the tumor, is a promising therapy with the potential to be more effective and better tolerated by patients. "

Dr. Maud Brandely, PhD, Director, Clinical Development, Clinical Operations & Regulatory Affairs at Transgene, adds, "With its multiple mechanisms of action, TG6002 is an extremely promising oncolytic virus that is administered intravenously in this trial. The destruction of cancer cells, the production of chemotherapy in the tumor and the induction of a targeted immune response are all complementary approaches to better attack this disease. We look forward to the results that the oncolytic virus TG6002 will generate in this clinical trial. "

This half-open, single-arm trial is being conducted in Europe. It evaluates the safety and tolerability of multiple and increasing doses of intravenously administered TG6002 in combination with orally administered 5-FC. 5-FC is a non-cytotoxic precursor that can be converted to 5-FU. The primary endpoint of the Phase 1 part of the trial is safety; that of Phase 2 is efficiency. This trial will also evaluate the pharmacokinetic properties and biodistribution of TG6002, as well as the immune modulation of the tumor microenvironment.

About TG6002 A
new generation of oncolytic immunotherapy, TG6002 has been designed to induce the destruction of cancer cells (oncolysis) and to allow the production of 5-FU directly in the tumor. TG6002 is a modified, double-deleted Vaccinia virus (TK-RR-), expressing the patented FCU1 gene in tumor cells that it has infected in order to locally convert 5-FC (flucytosine), into 5-FU, a chemotherapy commonly used. Oncolytic virus TG6002 has shown its efficacy and good tolerability profile in several preclinical models. For Transgene, TG6002 represents a new therapeutic option for patients with recurrent solid tumors.
Another trial of TG6002 is underway in France in recurrent glioblastoma.

About gastrointestinal tumors
Gastrointestinal cancers include several forms of cancers of the digestive system. They include cancers of the esophagus, gall bladder, liver, pancreas, stomach, small bowel, colon, rectum and anus. Colorectal cancer (CRC) is the second most frequently diagnosed cancer in Europe and one of the leading causes of death in Europe and worldwide. In 2012, 447,000 new cases of CRC were reported in Europe, with 215,000 deaths. Worldwide, this represented 1.4 million new cases and 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Over the last decade, the prognosis of patients with metastatic CRC has improved