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    TNG   FR0005175080

TRANSGENE

(TNG)
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Transgene Presents Data from Phase I Clinical Trial Confirming the Potential of the Oncolytic Virus TG6002

09/16/2021 | 02:30am EDT

Transgene announced 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 VVcopTK-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 USEDTO 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. 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. 5-FU and its final metabolite F-BAL were detected in tumor tissue and in peripheral blood at days 5, 7 and 14 in most of the evaluable patients across the three dose-level cohorts. Interestingly, patients with the highest levels of 5-FU in blood and tumor were patients for which there was direct evidence of TG6002 in the tumor. As of today, dose escalation has been completed. The trial is currently enrolling patients in additional cohorts assessing several administration schedules. Title of the poster: “Bioavailability and activity of oncolytic virus TG6002 after intravenous administration in patients with advanced gastrointestinal carcinomas” Authors: Philippe Cassier, Victor Moreno, Bernard Doger, Emiliano Calvo, Maria De Miguel, Christiane Jungels, Kaïdre Bendjama, Philippe Erbs, Damien Carpentier, and Alain Sadoun. Detailed results: Direct evidence of TG6002 in the tumor, after intravenous administration, which remains active and effectively express FCU1 gene selectively in tumor tissue; Detection of 5-FU and its final metabolite F-BAL in tumor tissue and in peripheral blood in most of the evaluable patients across the three dose-level cohorts; Replication of TG6002 is concentrated in tumor cells as suggested by the absence of widespread virus distribution in the body and the clear association of FCU1 activity with high virus concentration in tumor tissue; TG6002 is well tolerated and no major toxicities limiting the dose escalation process were observed. About the trial (NCT03724071): This trial is a single-arm open-label Phase I/II trial evaluating the safety and tolerability of multiple ascending doses of TG6002 administered intravenously in combination with oral 5-FC, a non-cytotoxic pro-drug that can be converted in 5-FU, its active metabolite. Based on the safety profile of TG6002, several dose levels and administration schedules have been added to the initial Phase I clinical protocol. At the end of this Phase I part, Phase II patients will receive the recommended dose of TG6002. The trial has safety as primary endpoint for the Phase I part and efficacy for the Phase II part. The trial also evaluates pharmacokinetic properties and biodistribution of TG6002, along with immune modulation of the tumor micro-environment. This European study will enroll up to 40 patients suffering from advanced gastrointestinal carcinomas who have failed and/or are intolerant to standard therapeutic options in the Phase I part. Patients with colon cancer and liver metastases will be enrolled in the Phase II part.


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Sales 2021 11,1 M 12,9 M 12,9 M
Net income 2021 -27,0 M -31,3 M -31,3 M
Net cash 2021 44,7 M 51,8 M 51,8 M
P/E ratio 2021 -8,50x
Yield 2021 -
Capitalization 232 M 269 M 269 M
EV / Sales 2021 16,9x
EV / Sales 2022 27,1x
Nbr of Employees 133
Free-Float 44,0%
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Hedi Ben Brahim Chairman & Chief Executive Officer
Jean-Philippe Del Chief Financial Officer
Eric Quéméneur Chief Scientific Officer & Executive VP
Hemanshu Shah VP-Medical Affairs & International Development
Maud Brandely VP-Clinical Operations & Regulatory Affairs
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