Invectys begins INVAC-1 phase I clinical trial in cancer patients

A new clinical hope in cancer immunotherapy

Invectys announces today that it has initiated a phase I clinical trial of its immunotherapeutic drug candidate INVAC-1.

INVAC-1 is an innovative therapeutic DNA vaccine, which specifically targets the telomerase enzyme (hTERT) that is overexpressed in the vast majority of cancer cells and which plays a critical role in uncontrolled cell growth.

The trial has been initiated in two French major clinical oncology centers affiliated to the Parisian hospital network (AP-HP), Saint Louis and George Pompidou hospitals, for patients with advanced cancer. The main objectives of this study are to evaluate safety, tolerability and specific hTERT immune responses induced by INVAC-1. The secondary objective is to ascertain the efficiency of this novel immunotherapy drug in terms of disease response.

“The effective initiation of this Phase I clinical study is an important step forward for Invectys. In the light of preclinical studies and first encouraging clinical results, we are all confident about the success of this study and the new therapeutic perspectives that open up for patients” said Thierry Huet, PhD, Director of Research and Development of Invectys.

This trial is an open label, dose escalation study in patients with relapsed or refractory solid tumors. A total of 18 patients are scheduled to be included progressively in three cohorts according to three increasing dose-levels of INVAC-1, followed by an extension cohort at the optimum dose in terms of safety, tolerability and efficacy.

The first cohort of patients was treated at the first dose-level with success. INVAC-1 showed a good safety profile and was well tolerated at this initial dose.

Moreover, based on encouraging clinical observations, and on the request of the investigators, the treatment of patients from the first cohort was prolonged beyond the three months initially scheduled in the study protocol.

To date, the treatment of patients of the second cohort at the next dose-level has been initiated.

“The results obtained from patients of the first cohort treated with the initial dose show a good safety profile and an excellent tolerance” explains Rémy Defrance, MD, Invectys Medical Director who added, “first pharmacodynamic results are also very encouraging”.

“We are delighted with these very promising results which show the potential of our therapeutic vaccine INVAC-1 and confirm that our investors were right to have had confidence in our team. The 10 million euros raised by Invectys since 2010 allow us to plan future developments serenely, and we are currently drawing up our strategy for the upcoming Phase II trials” welcomed Pierre Langlade Demoyen, CEO and co-founder of Invectys.

In parallel to the ongoing clinical trial, Invectys has drawn up its global non-clinical program to support the development of INVAC-1towards Marketing Authorization Application (MAA). This program was endorsed by the European Medicines Agency (EMA) upon a Scientific Advice procedure.