PEP-Therapy and Institut Curie are conducting a first-in-human Phase Ia/b clinical trial of PEP-010 for the treatment of advanced solid tumors and in particular:

  • Platinum-Resistant Ovarian Cancer (PROC)
  • Pancreatic ductal adenocarcinoma (PDAC).

The clinical trial (NCT 04733027) is a dose escalation trial with expansion cohorts. The study is also conducted at three other clinical oncology centers, Gustave Roussy, the François Baclesse Center and Institut de Cancérologie de l’Ouest.

institut Marie Curie
Gustave Roussy
Centre de lutte contre le cancer
Centre de lutte contre le cancer
institut Marie Curie
Gustave Roussy
Centre de lutte contre le cancer

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:

  • Favorable safety and tolerability profiles
  • Recommended Phase 2 Dose (RP2D) determined in monotherapy and in combination with paclitaxel
  • Encouraging preliminary signals of antitumor activity:
    • 13 patients have shown Partial Response or Stable Disease,
    • 2 confirmed Partial Responses in combination with paclitaxel in ovarian and pancreatic cancers.

The Phase Ib clinical study is underway, focusing on two indications, PROC and PDAC, to confirm the safety and further investigate preliminary antitumor signals observed in Phase Ia. A new combination of PEP-010 with a standard-of-care in these two indications, gemcitabine, will also be evaluated.

PEP-010 is a first-in-class therapeutic peptide.

Pep-010 illustration

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 made of:

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 disrupt a Protein-Protein Interaction leading to the inhibition of key pathological mechanisms without altering physiological mechanisms. In the case of PEP-010, the interfering peptide disrupts the interaction between Caspase-9 and PP2A.

PEP-010 has shown a good safety profile and anti-tumor activity in several preclinical models with tumor growth inhibition up to 85% in breast and ovary Patient Derived Xenograft (PDX) tumor models. Additive effect of PEP-010 in combination with chemotherapies were also observed. Publications are available upon request, please contact us.


Pep-Therapy pipeline

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.