Transgene Confirms the Potential of the Intravenous Route of its Invir.IO™ Oncolytic Viruses against Solid Tumors with TG6002 Phase I Data Presented at ESMO Congress 2022

Additional positive TG6002 Phase I data show that the oncolytic virus is able to reach the tumor, replicate and express its payload in all patients when administered intravenously

Strasbourg, France, September 12, 2022, 8:00 am CEST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, today announces positive confirmatory data from the Phase I trial evaluating TG6002 administered intravenously (IV) in combination with oral 5-FC in patients with advanced gastrointestinal carcinomas.

TG6002 is based on Transgene’s double deleted VVcopTK-RR- patented virus backbone, which forms the basis of the company’s Invir.IO™ platform, and is generating a pipeline of multi-armed therapeutic OV drug candidates.

These updated data generated on 37 patients treated at the highest dose levels of the Phase I demonstrated that the therapy is well tolerated and confirmed the mechanism of action of TG6002 administered IV. They were presented on September 11, 2022, in a poster presentation at the European Society for Medical Oncology (ESMO) meeting taking place in Paris (France) from September 9-13, 2022.

The findings are as follows:

• TG6002 demonstrated good tolerability when administered weekly or on days 1,3 and 5. No major toxicities limiting the dose escalation process or the intensification of the schedule of administration were observed. Transient fever is the most common adverse event.
• TG6002 is able to reach the tumor, replicate, and express its payload after IV administration.
• Onset of a neutralizing antibody response is not associated with a decreased biological activity of the product.
• These data further confirm the mechanism of action of the Invir.IO™-based oncolytic viruses in humans.
• The two IV administration schedules display different characteristics, that can both be leveraged in upcoming clinical trials. Three doses given once a week resulted in higher levels of expression of the payload than the more intensive schedule (3 injections within 5 days). The intensive schedule allowed for a longer lasting expression of the payload.

These findings support the potential of IV administration of Invir.IO™-based oncolytic viruses, extending the use of these therapies to a broad range of solid tumors.

The overall Phase I program with TG6002 was aimed at establishing the tolerability and the potential different doses and administration schedules for further development. Additional data will be produced from the Phase I program and will be presented at a scientific congress in H1 2023.

• Title of the poster: “Updated data of biodistribution and activity of oncolytic virus TG6002 after intravenous administration in patients with advanced gastrointestinal carcinomas”
• Authors: Victor Moreno, Philippe Cassier, Bernard Doger, Emiliano Calvo, Maria De Miguel, Rocio Garcia-Carbonero, Carlos Gomez-Roca, Christiane Jungels, Sophie Sainte-Croix, Philippe Erbs, Alain Sadoun and Kaïdre Bendjama
• Abstract Number: #4886
• Poster Number: 392P

The abstract and the e-poster are available on the ESMO congress website here and the e-poster can be downloaded on the Transgene website here as well.