First Patient Enrolled in Phase I/IIa Trial for TheraVectys' Lenti-HPV-07 Vaccine

TheraVectys, a biotechnology firm specializing in lentiviral vector-based vaccines and immunotherapies for infectious diseases and cancers, has announced the commencement of the Phase I/IIa clinical trial for its vaccine candidate Lenti-HPV-07. This vaccine aims to treat cancers induced by the human papillomavirus (HPV). The inaugural enrolment marks a significant step in evaluating the vaccine's potential to address HPV-related malignancies.

The clinical trial will involve 36 patients following a dose-escalation protocol across several cancer centers in the United States. These patients are being carefully selected and included in the trial. The Lenti-HPV-07 vaccine leverages lentiviral vector technology, a platform developed by the Pasteur-TheraVectys Joint Laboratory, which has been under development for almost two decades. The preclinical studies have shown promising results, indicating that a single intramuscular injection of the vaccine can trigger a robust cellular immune response against the E6 and E7 antigens of HPV16 and HPV18.

The vaccine demonstrated complete tumor elimination in preclinical models, long-lasting immune memory, elimination of metastases, and strong synergy with treatments like anti-PD1 antibodies. The trial aims to evaluate the safety, immunogenicity, and preliminary efficacy of Lenti-HPV-07, particularly focusing on the Objective Response Rate.

The trial will consist of two patient groups, both monitored for one year. Group A will include patients with recurrent or metastatic cancers who have not responded to other treatments. They will receive two intramuscular injections of Lenti-HPV-07 one month apart. Group B will comprise newly diagnosed, treatment-naïve patients with locally advanced cancers, receiving a single injection. The trial has two parts: dose escalation and dose expansion. Participants will receive increasing doses, monitored for safety at each step, before proceeding to higher doses. Once 18 participants in each group have been successfully treated and safety confirmed, an additional 18 patients will be enrolled to receive the Optimal Biological Dose.

TheraVectys has previously completed a Phase I trial for a therapeutic HIV-1 vaccine that revealed no significant side effects over a five-year follow-up. The current trial for Lenti-HPV-07 uses a non-integrative lentiviral vector, enhancing the safety profile. Newly diagnosed patients in Group B, whose immune systems remain unaffected by other treatments, will receive standard care, including anti-PD1 treatments, one month after the Lenti-HPV-07 injection. The vaccine has shown a synergistic effect with anti-PD1 treatments, increasing their efficacy substantially.

Professor Christian Bréchot, Medical Director of TheraVectys, emphasized the significance of enrolling the first patient, marking the culmination of extensive preparation and collaboration. Pierre Charneau, head of the Pasteur-TheraVectys Joint Laboratory and founder of TheraVectys, expressed pride in advancing their product to a new developmental phase, anticipating initial safety and immunogenicity results soon.

HPV is a major cause of various cancers, including almost all cervical cancers and many oropharyngeal and anogenital cancers. Although existing preventive HPV vaccines can induce neutralizing antibodies to prevent infection, they do not affect chronic HPV infections or established tumors. Lenti-HPV-07 has shown superior efficacy in preclinical studies compared to mRNA-based vaccine technologies, which have been less effective against larger, more challenging tumors.

TheraVectys holds an exclusive license from Institut Pasteur for human and animal vaccine applications of lentiviral vectors. This technology, interacting with dendritic cells, stimulates potent T cell responses, crucial for combating tumor cells. The company's work is poised to revolutionize vaccination by addressing unmet medical needs in infectious diseases and cancers. TheraVectys aims to transform global health through strategic industrial partnerships, advancing vaccine candidates from proof of concept to clinical trials and eventually to market.