PEP-010, first therapeutic product
PEP-Therapy and Institut Curie have been granted approval from ANSM to start first-in-human clinical trial of PEP-010 for the treatment of advanced solid tumors
PEP-Therapy will first focus on the clinical development of PEP-010, its lead product, a first-in-class targeted approach to cancer therapy and a pro-apoptotic agent.
PEP-010 is PEP-Therapy's first CP&IP-based product.
PEP-010 dissociates the interaction between Caspase-9 and PP2A, two key proteins in the apoptotic pathway. Caspase-9, thus released, can be activated, restoring normal apoptosis (physiological cell death) in cancer cells.
PEP-010 in a single linear 30-aa peptide comprises:
A CPP to deliver the active peptide into the cellular cytosol;
An interfering active peptide, blocking caspase-9/PP2A interaction.
PEP-010 has demonstrated preclinical proof of concept in particular in a wide range of patient-derived xenograft (PDX) animal models with proven anti-tumour efficacy. PEP-010 inhibits tumour growth in human breast and ovary primary tumours, from 30 to 85%.
We observed an additive effect of PEP-010 in combination with chemotherapies, taking advantage of their different mechanisms of action.
Repeated GLP-toxicity studies by intravenous route in rat and monkey (4 weeks and 2 weeks of recovery) showed a good systemic tolerance of PEP-010.
The GMP batch is released. Phase Ia/b study is starting in Q2 2021.
Based on the proof-of-concept on lead product, PEP-Therapy will reinforce the product pipeline based on its CP&IP technology.