PEP-Therapy and Institut Curie are conducting a first-in-human clinical trial of PEP-010 for the treatment of advanced solid tumors and in particular Platinum-Resistant Ovarian Cancer (PROC) and Pancreatic ductal adenocarcinoma (PDAC). The clinical trial (NCT 04733027) is a dose escalation trial (Phase Ia) with an expansion phase (Phase Ib). The study is also conducted at two other clinical oncology centers, Gustave Roussy and the François Baclesse Center.
The trial 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. Named ‘CleverPeptide’, it is an open-label, non-controlled, multicenter clinical trial.
Our lead product, PEP-010, has completed its Phase Ia clinical study. Results obtained in 34 patients with recurrent and/or metastatic solid tumors, showed good safety profile of PEP-010 in monotherapy, the Recommended Phase 2 Dose (RP2D) being the highest dose level tested. In combination with paclitaxel, preliminary antitumor activity (confirmed Partial Responses) was observed, including in patients who had previously received taxane-based therapies.
PEP-010 clinical development continues with a Phase Ib focusing on two indications, PROC and PDAC, to confirm the RP2Ds and investigate preliminary antitumor signals observed in Phase Ia in these populations.
PEP-010 is a first-in-class therapeutic peptide.
PEP-010, PEP-Therapy’s lead product, dissociates the interaction between Caspase-9 and PP2A, two key proteins in the apoptotic pathway. PP2A and Caspase-9, when released, restore normal apoptosis (physiological cell death) in cancer cells.
PEP-010 comprises two features in a single peptide, based on our innovative and patented CP&IP (Cell Penetrating & Interfering Peptides) technology:
An optimized Cell-Penetrating Peptide (CPP), as a “shuttle” to deliver the active peptide into the cellular cytosol;
A short Interfering Peptide, specifically designed to block Caspase-9/PP2A interaction leading to the inhibition of key pathological mechanisms without altering physiological mechanisms.
PEP-010 demonstrated a good safety profile and anti-tumor efficacy in multiple preclinical models and has shown to inhibit tumor growth in breast and ovary Patient Derived Xenograft (PDX) tumor models by up to 85%. Additive effect of PEP-010 in combination with chemotherapies were also observed. Publications are available upon request, please contact us.
Based on the proof-of-concept and the experience gained on its lead product, PEP-010, PEP-Therapy develops a pipeline of peptide-based products in oncology.