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Institut Curie & PEP-Therapy initiate a Phase I clinical trial for the treatment of advanced solid tumors

Institut Curie
03/11/2021
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Institut Curie & its spin-off PEP-Therapy, have been granted approval from the ANSM to proceed with the first-in-human clinical trial of PEP-Therapy’s lead drug candidate, for the treatment of advanced solid tumors.
IC & PEP-Therapy

Institut Curie & PEP-Therapy, have been granted approval from the French National Agency for Medicines and Health Products (ANSM) to proceed with the first-in-human clinical trial of PEP-Therapy’s lead drug candidate, PEP-010. Spin-off from Institut Curie founded in 2014, PEP-Therapy is a biotech company developing cell penetrating peptides as targeted therapies in oncology.

 

PEP-010 is a first-in-class therapeutic peptide based on PEP-Therapy’s innovative Cell Penetrating and Interfering Peptides technology. These innovative molecules penetrate cells and specifically block relevant intracellular protein-protein interactions, leading to the inhibition of key pathological mechanisms, without altering physiological ones. PEP-010 is a pro-apoptotic agent which has demonstrated anti-tumor efficacy in a number of pre-clinical models and a good safety profile.

Sponsored by Institut Curie, the clinical trial of PEP-010 is an open-label, non-controlled, multicenter, dose escalation, first-in-human Phase I clinical trial with an expansion Phase. This Phase Ia/b study has been designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of intravenous PEP-010, administered as a single agent and in combination with paclitaxel in patients with recurrent and/or metastatic solid tumors, and in particular in Triple Negative Breast Cancer (TNBC) and Ovarian Cancer (OC). The study will be led by Pr. Christophe Le Tourneau, Medical Oncologist and Head of Department of Drug Development and Innovation (D3i) at Institut Curie. He declares:

This exciting step has been achieved through a strong collaboration between PEP-Therapy and Institut Curie since its inception, demonstrating the ability to develop innovative therapeutics emerging from French institutional research. I am very pleased to involve the D3i - Department of Drug Development and Innovation - in this clinical trial.

Antoine Prestat, CEO and co-founder of PEP-Therapy adds:

We are pleased to have been granted approval by ANSM to start this first-in-human clinical trial of PEP-010. This is a major milestone for PEP-Therapy and our partners, amongst which Institut Curie and Sorbonne University where our technology originated from. PEP-010 aims to fight cancers with poor prognosis for which there are only few or no therapeutic alternatives. We look forward to starting this trial in the coming weeks and to generating results that we hope will confirm the promising results seen in preclinical studies.

 

The study will be conducted in three clinical centers in France: Institut Curie, Gustave Roussy and the François Baclesse Center.