Transgene Presents Data From Phase I Clinical Trial Confirming the Potential of the Oncolytic Virus TG6002

Regulatory News:

Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, today announces the presentation of data from a Phase I study combining intravenous (IV) oncolytic virus TG6002 and oral 5-FC in patients with advanced gastrointestinal carcinomas at the European Society for Medical Oncology (ESMO) virtual meeting taking place from September 16-21, 2021.

These important data further confirm that Transgene’s double deleted VV_copTK^-RR^- patented virus backbone, which forms the basis of the company’s Invir.IO platform, has the potential to be given intravenously. After IV administration, TG6002 is able to selectively replicate and persist in tumor cells leading to the local expression of its functional payload (the FCU1 gene).

INTRAVENOUS ADMINISTRATION COULD ALLOW ONCOLYTIC VIRUSES FROM TRANSGENE’S INVIR.IO PLATFORM TO BE USED TO TREAT A BROAD RANGE OF SOLID TUMORS

To date, the only oncolytic virus to have received regulatory approval has to be given via intra-tumoral administration, restricting its use to superficial lesions. Transgene’s ambition is to significantly enlarge the number of solid tumors, such as gastro-intestinal tumors, that could be addressed by an oncolytic virus, by developing oncolytics administered intravenously.

TG6002 has been designed to combine multiple mechanisms of action: the lysis of tumor cells, the production of a chemotherapy agent 5-FU directly in the tumor and the induction of an immune response against cancer cells. This concept is presented in a short video available by clicking here.

The Phase I data that will be presented at the ESMO congress further demonstrate that TG6002 persists selectively in cancer cells while expressing its transgene of interest. This finding supports the potential of IV administration of Invir.IO-based oncolytic virus, extending the use of these therapies to a broad range of solid tumors.

DATA CONFIRM THE PERSISTENCE OF THE CHEMOTHERAPY AGENT 5-FU IN PATIENTS’ TUMORS AFTER INTRAVENOUS ADMINISTRATION

The data also demonstrate that the chemotherapy agent 5-FU is produced in the tumor across the three dose-level cohorts (3x10⁸ pfu, 1x10⁹ pfu and 3x10⁹ pfu). 5-FU results from the local conversion of the pro-drug 5-FC (administered orally) allowed by the in-tumor expression of the proprietary FCU1 gene that has been integrated within the genome of TG6002.