Invectys publishes positive clinical results for its INVAC-1 Phase I Study in Clinical Cancer Research

 

With an extended Phase I and a new delivery method for INVAC-1, Invectys makes important progress towards new treatments for cancer

 

Paris, December 17th, 2019 – Invectys announces the publication of the results of its extended Phase I clinical study in 26 advanced cancer patients using INVAC-1, its lead product. Targeting the human telomerase enzyme, a universal cancer antigen, INVAC-1 was tested on patients from multiple indications, first through electroporation then through a needle-free delivery device. The article, entitled “A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors”, was published in Clinical Cancer Research on November 19th, 2019 (DOI: 10.1158/1078-0432.CCR-19-1614).

Overall, results demonstrated the potential of INVAC-1, with 58% patients demonstrating disease stabilization, 65% reaching the one-year survival mark, a 2.7 months median Progression-Free Survival and a 15 months median Overall Survival. INVAC-1 was shown to stimulate specific anti‑hTERT CD4 T and cytotoxic CD8 T cell responses. Additionally, the vaccination was well tolerated, and the study did not find any Dose-Limiting Toxicity.
This publication follows communications already made this year at ASCO (Chicago, June 2019) and CICON (Paris, September 2019), in which were disclosed additional supportive results such as combinational efficacy data with immune checkpoint inhibitors (anti-PD1 monoclonal antibodies) and antigen spreading assessment comforting the mechanism of action of INVAC-1.

“Given the severity of our Phase I patients, we see these results as very positive for cancer patients everywhere. The universal range of INVAC-1 could make a difference in the lives of millions of patients, present and future”, says Invectys CEO Pierre Langlade-Demoyen. “These outcomes give us hope to obtain even better results for earlier-stage patients and in studies in combination with other immunotherapies such as immune checkpoint inhibitors”, adds R&D Director Thierry Huet.

INVAC-1 is currently in a Phase II international study (US and EU) in Chronic Lymphocytic Leukemia. Trials in further solid tumor indications are currently planned for 2020.

About Invectys

Founded in 2010 at the Pasteur Institute in Paris, Invectys SA is a biopharmaceutical company focused on the development of innovative immuno-oncology treatments cutting across many cancers. Having raised €38 million, the company has developed a broad pipeline including therapeutic vaccines and immune checkpoint inhibitors. Invectys has two products in Phase II clinical trials in Europe and the US. Both products enlist and restore the natural antitumor efficacy of cancer patients’ immune systems.

About INVAC-1

The company’s lead product, INVAC-1, is a human telomerase DNA-based anti-cancer vaccine. It aims at mobilizing the immune system against the human telomerase complex (named hTERT), which is overexpressed in more than 85% of human tumors, but is virtually absent from normal cells. The vaccine activates the CD8+ Cytotoxic T cells, also called killer T Cells, which are capable of killing cancer cells. It also turns on CD4+ T helper cells, which regulate the immune response and stimulate the cytotoxic T cells.
INVAC-1 has completed its Phase I trial in various advanced cancer indications, demonstrating very encouraging safety, efficacy and immune response results. The Phase II trial in Chronic Lymphocytic Leukemia (CLL) began in August 2018.

Invectys press contact:

Gilles Petitot – Agence Acorelis – gilles.petitot@acorelis.com