Actualité - Innovation

Ovarian and pancreatic cancers: the first patients treated in a promising clinical trial by Institut Curie and its spin-off PEP-Therapy

04/25/2024

Institut Curie and its spin-off PEP-Therapy, specialized in the development of penetrating peptides as targeted therapies in oncology, announce that PEP-010, PEP-Therapy's drug candidate, has been administered to initial patients in the Phase Ib clinical trial, following encouraging Phase Ia results. This study is being conducted for the treatment of ovarian and pancreatic cancers, by Prof. Christophe Le Tourneau, head of the department of Drug development and innovation (D3i) at Institut Curie.

PEP-010 is a first-in-class bifunctional therapeutic peptide that penetrates cells and specifically disrupts the interaction between Caspase-9 and PP2A, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms. PEP-010 is a pro-apoptotic agent which has demonstrated a good safety and tolerability profile and first signals of efficacy in the CLEVer-PEPtide Phase Ia dose escalation clinical trial.

The two-cohort, open-label, non-controlled, multicenter Phase Ib program will evaluate the safety and tolerability, complete or assess the pharmacokinetics, and evaluate the anti-tumor activity of intravenous PEP-010 when administered in combination with paclitaxel or gemcitabine. The first cohort (expansion cohort) will evaluate the efficacy of PEP-010 at the recommended Phase II dose (RP2D) in combination with paclitaxel in patients with metastatic PDAC. The second cohort (dose escalation) will determine the maximum tolerated dose (MTD) and the RP2D of PEP-010 when administered in combination with gemcitabine in patients with metastatic PDAC or advanced or metastatic OC. Target enrollment is up to 53 patients. Four sites in France are currently recruiting: Institut Curie, Gustave Roussy, Centre François Baclesse and Institut de Cancérologie de l'Ouest.

We are thrilled to see the first patients dosed in this Phase Ib trial. PEP-010 represents a potentially safer and effective new option for patients with few therapeutic alternatives. I am delighted to work with our clinical team and the different centers to determine if PEP-010, when combined with chemotherapies, can provide therapeutic benefits for patients.

said Pr. Christophe Le Tourneau, Medical Oncologist at Institut Curie, Head of the Department of Drug Development and Innovation (D3i), and Principal Investigator of the CLEVer-PEPtide trial.

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

We are delighted with the start of our Phase Ib trial, and we are grateful for the support of the participating cancer centers which has enabled this important new milestone for our company. This study reflects our commitment to provide a new treatment that addresses unmet medical needs and improve patient outcomes in combination with the standard-of-care. Reactivating apoptosis of cancer cells using peptide technology represents a promising and innovative therapeutic modality. We look forward to confirming the potential of PEP-010 in this Phase Ib trial.

Encouraging data from the Phase Ia study were presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics 2023 confirming the safety of PEP-010 with encouraging preliminary signals of antitumoral activity in 13 patients who experienced partial response or stable disease, including 2 confirmed partial responses in combination with paclitaxel in ovarian and pancreatic cancers, along with a good safety profile in patients with recurrent and/or metastatic solid cancers.