PARIS - Transghne S.A. has embarked on its first Phase I clinical trial of its MVA-HPV-IL2 anti-cancer vaccine, which is being tested in cervical cancer. The trial is being conducted at the Baylor College of Medicine in Houston and is being carried out on patients with a pre-cancerous cervical infection (grade 3 intraepithelial neoplasia).
Further trials of the same vector are about to get under way elsewhere in the U.S. and in Switzerland.
MVA-HPV-IL2 associates a pox virus vector derived from the highly attenuated modified virus ankara (MVA) strain with antigens of the human papilloma virus type 16 (HPV-16), which is responsible for more than 50 percent of cervical cancers. The clinical trials are aimed at evaluating the efficacy of this vaccine for treating and preventing cervical cancers caused by HPV-16.
This is one of two lead products in the Strasbourg-based gene therapy company's specific immunotherapy program for cancer, the other being a vaccinia virus recombinant expressing the tumor antigen MUC1 (for breast, pancreatic and ovarian cancers). Animal studies have shown that immunization with these recombinants, especially when co-expressing interleukin-2 or other immunomodulators, triggers a tumor-specific cytotoxic T-cell response with a strong antitumor effect.
Transghne's work in the field of anticancer vaccines recently received official recognition in the form of a fundamental patent granted by the U.S. Patent Office for the "expression of a specific tumor antigen by a recombinant viral vector and utilization of the latter." It covers methods for treating tumors of viral origin and vectors carrying at least the essential region of a non-structural protein of the HPV-16 papilloma virus.
The clinical trial now under way at Baylor College is the third for which Transghne has obtained FDA approval. Transghne now has six different products in clinical development, four of which are in Phase II trials for the treatment of various types of cancer, including the MUC1-IL2 vector for the treatment of advanced breast cancer. The other main pathology the company is targeting is cystic fibrosis, using an adenoviral vector that delivers the CFTR gene.