NEW YORK – TheraVectys on Friday said it began a Phase I/IIa trial of its Lenti-HPV-07 vaccine candidate as a treatment for human papillomavirus-induced cancers.
In the trial, investigators will assess the safety, immunogenicity, and preliminary efficacy of ascending doses of Lenti-HPV-07 in about 72 patients with oropharyngeal or cervical cancers driven by HPV-16 or HPV-18. The trial will include one group of patients with recurrent or metastatic cancers that have not responded to multiple treatment lines, including immunotherapies, that will received two injections of Lenti-HPV-07 a month apart and another group with newly diagnosed, treatment-naïve, locally advanced cancers that will receive a single injection. Patients in the second group will receive standard treatment for their cancers beginning one month after the Lenti-HPV-07 injection.
Once 18 patients in each group have been safely treated in the dose-escalation part of the trial, it will progress to a dose expansion phase for another 18 patients in each group at the optimal dose.
TheraVectys, which is headquartered in Paris, developed Lenti-HPV-07 using lentiviral vector technology licensed from Institut Pasteur. The vaccine is designed to stimulate an immune response by interacting with dendritic cells. In preclinical studies, a single intramuscular injection of the vaccine induced a strong cellular immune response against the E6 and E7 antigens of HPV-16 and HPV-18 leading to complete elimination of HPV-induced tumors and metastases in 100 percent of animals and a long-lasting immune memory. The company also found that Lenti-HPV-07's activity was synergistic with anti-PD1 therapy.