Transgene has started dosing patients with recurrent glioblastoma in a Phase I/IIa clinical trial conducted to evaluate its oncolytic virus TG6002.
Being developed as an intravenous formulation, TG6002 is said to have various functions and a dual mechanism of action to improve anti-tumour selectivity and activity.
TG6002 is designed to combine oncolysis by tumour-selective viral replication with local delivery through production of 5-FU chemotherapy agent in the tumour.
Additionally, the candidate is expected to trigger an immune response after spreading of the antigen due to breakdown of the cancer cells.
The open-label Phase I/IIa trial will investigate the safety and tolerability of different increasing doses of intravenous TG6002 combined with an oral non-cytotoxic pro-drug, flucytosine called 5-FC.
As TG6002 expresses Fcu1 gene in the targeted cancer cells, it would locally convert the 5-FC into 5-FU.
The firm has started treatment at the La Pitié-Salpêtrière hospital, Greater Paris University Hospitals in Paris, France.
Transgene chief medical officer Maud Brandely said: “Based on our compelling preclinical data, we have established that its replication induces immunogenic cell lysis and the local production of chemotherapy.
“We are excited to see this novel immunotherapy with multiple modes of action enter the clinic and look forward to obtaining results that will allow further development of TG6002 in several solid tumours indications.”
The trial will include patients who have failed standard of care therapy and will monitor anti-tumour activity of TG6002.
Preliminary results from the Phase I/IIa trial are expected to be available in the second half of next year.