TheraVectys, a biotechnology company specializing in lentiviral vector-based vaccines and immunotherapies, has begun enrolling patients in a Phase I/IIa clinical trial to evaluate the efficacy and safety of Lenti-HPV-07, a therapeutic vaccine targeting human papillomavirus (HPV)-induced cancers.
The trial employs a dose-escalation protocol and will involve 36 patients with HPV-16 or HPV-18-induced oropharyngeal or cervical cancers. Group A will include patients with recurrent/metastatic cancers, while Group B will consist of newly diagnosed, treatment-naïve patients.
Lenti-HPV-07 is based on the lentiviral vector technology developed by Pasteur-TheraVectys Joint Laboratory. Preclinical studies have demonstrated its ability to induce a robust cellular immune response against HPV16 and HPV18 antigens.
The Phase I/IIa trial will assess the safety and immunogenicity of Lenti-HPV-07, as well as its preliminary efficacy through the Objective Response Rate. Patients will be followed clinically and immunologically for one year.
The trial is divided into two parts: dose escalation and dose expansion. In the dose escalation portion, participants will receive increasing doses of Lenti-HPV-07, with safety monitoring preceding each dose increase. Upon reaching a satisfactory safety profile, a dose-expansion portion will treat 18 additional patients at the Optimal Biological Dose.
TheraVectys has previously conducted a Phase I clinical trial with a therapeutic HIV-1 vaccine using an integrative lentiviral vector, demonstrating no significant side effects or genotoxicity. The current Lenti-HPV-07 trial employs a non-integrative lentiviral vector, further enhancing safety.
The initiation of this trial marks a significant step in the development of Lenti-HPV-07 as a potential therapeutic option for HPV-induced cancers. The trial data is expected to provide insights into its safety, immunogenicity, and efficacy in this patient population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
