Scienza e Tecnologia
PEP-Therapy and Institut Curie announce first patients dosed in Phase I clinical trial of PEP-010 for the treatment of advanced solid tumors
The trial has been initiated at Institut Curie and is led by Professor Christophe Le Tourneau , Medical Oncologist at Institut Curie and Head of the Department of Drug Development and Innovation (D3i), and Principal Investigator of the trial. The main objectives of this Phase Ia/b trial are to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of intravenous PEP-010, administered as a single agent and in combination with paclitaxel, a taxoid chemotherapeutic agent, in patients with recurrent and/or metastatic solid tumors, and in particular in Triple-Negative Breast Cancer (TNBC) and Ovarian Cancer (OC).
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The clinical trial, named 'CleverPeptide' (NCT 04733027), is an open-label, non-controlled, multicenter, dose escalation trial (Phase Ia) with an expansion phase (Phase Ib). It is estimated that a total of 56 adult patients will be recruited gradually, with increasing dose levels of PEP-010 in monotherapy, then in combination with paclitaxel, with a goal of establishing a Maximum Tolerated Dose (MTD). Two expansion cohorts at this MTD will follow to confirm safety data and evaluate preliminary efficacy.
The study will also be conducted at two other clinical oncology centers, Gustave Roussy and the François Baclesse Center, where patients will receive the next dose levels.
PEP-Therapy is a French clinical-stage biotechnology company developing first-in-class peptides as targeted therapies in oncology, based on the Company's innovative ell enetrating and nterfering eptides (CP&IP) 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 mechanisms.
PEP-Therapy, which was founded in 2014 and builds on research from Sorbonne University and Institut Curie, is backed by international investors: Anaxago, i&i Prague , Italian Angels for Growth (IAG), Doorway, Magna Capital Partners (MCP), Business Angels des Grandes Ecoles (BADGE), Seventure Partners (Quadrivium 1 Seed Fund), and Dr. Bernard Majoie (former Chairman and CEO of Laboratoires Fournier, Founding Chairman of Fournier-Majoie Foundation for Innovation).
For more information, please visit www.pep-therapy.com
Institut Curie, France's leading cancer center, combines an internationally-renowned research center with a cutting-edge hospital group that treats all types of cancer, including the rarest. Founded in 1909 by Marie Curie , Institut Curie employs 3,600 researchers, physicians, and health professionals across three sites ( Paris , Saint-Cloud, and Orsay), working on its three missions: treatment, research, and teaching. A private foundation with public utility status, Institut Curie is authorized to receive donations and legacies, and thanks to the support of its donors, is able to make discoveries more quickly, improving treatments and quality of life for patients.
For more information, please visit: www.curie.fr
Antoine Prestat, CEO & co-founder
hello.pep@pep-therapy.com
+33 1 81 70 76 82
Sylvie Berrebi , David Dible
PEP-Therapy@medistrava.com
+44 (0)7714 306525
Elsa Champion , Press Relations Officer
elsa.champion@curie.fr
+ 33 7 64 43 09 28