TheraVectys, a biotechnology firm focused on creating lentiviral vector-based vaccines and immunotherapies for infectious diseases and cancers, has announced the enrollment of the first patient in a Phase I/IIa clinical trial for its onco-therapeutic vaccine, Lenti-HPV-07. This trial aims to evaluate the vaccine’s effectiveness in treating human papillomavirus (HPV)-induced cancers.
TheraVectys has announced the enrollment of the first patient in a Phase I/IIa clinical trial for its onco-therapeutic vaccine, Lenti-HPV-07, targeting human papillomavirus (HPV)-induced cancers. This study will include 36 patients in a dose-escalation protocol at various cancer centers across the U.S., with patient selection already in progress.
Lenti-HPV-07 is built on a lentiviral vector technology platform developed through a collaboration with the Pasteur-TheraVectys Joint Laboratory. Promising preclinical results published in EMBO Molecular Medicine and NPJ Vaccines indicated that the vaccine induced strong immune responses against the E6 and E7 antigens of HPV16 and HPV18, leading to:
- Complete tumor elimination in 100% of cases, regardless of tumor size
- Long-lasting immune memory primarily through anti-tumor cytotoxic CD8+ T cells
- Significant remodeling of the tumor microenvironment
- Complete elimination of metastases
- Enhanced synergy with anti-PD1 treatments, even at sub-optimal doses
Trial Design and Methodology
The open-label Phase I/IIa trial aims to assess the safety, immunogenicity, and preliminary efficacy of Lenti-HPV-07. It will include two patient groups:
- Group A: Patients with recurrent/metastatic cancers unresponsive to multiple treatments, who will receive two injections one month apart.
- Group B: Newly diagnosed, treatment-naïve patients with locally advanced cancers, receiving a single injection.
The trial consists of a dose escalation phase, where participants receive increasing doses of Lenti-HPV-07, and a subsequent dose expansion phase for patients at the Optimal Biological Dose, totaling 72 patients.
TheraVectys has previously completed a Phase I trial for a therapeutic HIV-1 vaccine without notable side effects. The current trial uses a non-integrative lentiviral vector, enhancing safety.
Group B patients, being newly diagnosed, will begin standard care, often including anti-PD1 treatments, one month post-injection. Preclinical studies have shown that Lenti-HPV-07 synergizes with anti-PD1, significantly increasing efficacy.
Key Milestones and Future Expectations
Professor Christian Bréchot, TheraVectys’ Medical Director, noted that this patient enrollment marks a significant milestone after over 2.5 years of preparation, including FDA interactions and vaccine production. Pierre Charneau, head of the Pasteur-TheraVectys Joint Laboratory, expressed pride in advancing the product to a new development phase, with preliminary safety and immunogenicity results expected shortly after completing the final injections in one patient group.
HPV is responsible for almost all cervical cancers, as well as many oropharyngeal and anogenital cancers. Current HPV vaccines primarily prevent infection but do not address existing chronic infections or tumors. In contrast, Lenti-HPV-07 has demonstrated efficacy against larger tumors, offering a potential breakthrough in HPV-related cancer treatment.
About TheraVectys and Lentiviral Vector Technology
TheraVectys specializes in immunotherapy, leveraging over 20 years of lentiviral vector research. Its technology stimulates the body’s immune defenses more effectively than other vaccine strategies, particularly by engaging dendritic cells to enhance T cell responses against tumors.
TheraVectys aims to address unmet medical needs in cancer and infectious diseases, striving to make significant improvements in global health through strategic industrial partnerships and innovative vaccine candidates.
