– Targeting to initiate dosing of Phase 1 clinical trial in Q1 2024 to evaluate Lenti-HPV-07 in patients having oropharyngeal or cervical cancers induced by HPV16 or 18

– The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of Lenti-HPV-07 in 36 patients

– Lenti-HPV-07 preclinical profile and clinical development carried out by the Pasteur- TheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023

On November 27, 2023, TheraVectys a lentiviral vector immunotherapy company focused on developing vaccine candidates to drive the widespread treatment and prevention of cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its safety review of the Investigational New Drug (IND) application and concluded that TheraVectys’proposed clinical study may proceed to evaluate the onco- therapeutic vaccine Lenti-HPV-07 for the treatment of human papillomavirus (HPV)-induced cancers.

The lentiviral vector-based intramuscular vaccine candidate has already demonstrated 100% preclinical efficacy against HPV-induced cancers. The results of the pre-clinical development work carried out by the Pasteur-TheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023, in an article entitled : “Full eradication of pre-clinical human papilloma virus-induced tumors by a lentiviral vaccine”.
https://www.embopress.org/doi/full/10.15252/emmm.202317723

The clinical trial, scheduled to begin in the first quarter of 2024, will be conducted in the U.S. at four cancer centers, including Florida’s Moffitt Cancer Institute.

The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of Lenti- HPV-07 and determine its immunogenicity profile. It will include 36 patients with oropharyngeal or cervical cancers induced by HPV16 or 18. Group A will consist of patients with recurrent/metastatic cancers who have received multiple lines of treatment, including immunotherapies, and Group B of patients with newly diagnosed, treatment-naïve, locally advanced cancers. Patients in Group B will receive a single intramuscular injection of Lenti-HPV-07, while those in Group A will receive two intramuscular injections one month apart. They will be monitored clinically and immunologically for one year.

Development of an onco-therapeutic vaccine candidate against human papillomavirus (HPV)-induced cancers, based on preclinical results showing 100% efficacy

The Biotech TheraVectys, in collaboration with Institut Pasteur-TheraVectys Joint Laboratory, has just demonstrated the preclinical efficacy of its “Lenti-HPV-07” lentiviral vector-based vaccine candidate, administered intramuscularly, against cervical and oropharyngeal cancers induced by human papillomavirus (HPV).

“ Our vaccine candidate induces a 100% tumor eradication in our preclinical model and a long-term memory immune response that prevents the risk of tumor relapse. This technological advance enables us to expect a major clinical benefit in the treatment of HPV cancer, and offers very promising prospects for other tumor indications. These results are far superior to those obtained in the same pre-clinical model by other vaccine technologies, notably mRNA “.
Pierre Charneau, CSO of TheraVectys

These results were published in EMBO Molecular Medicine journal on September 7, 2023, in an article entitled “Full eradication of pre-clinical human papilloma virusinduced tumors by a lentiviral vaccine”.