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DRUG:

PEP-010

i
Other names: PEP-010, PEP 010, DPT C9h
Associations
Trials
Company:
PEP-Therapy
Drug class:
PP2A inhibitor, CASP9 inhibitor
Associations
Trials
9d
First-in-human Phase I to Evaluate PEP-010 As Single Agent and in Combination with Paclitaxel or with Gemcitabine (CleverPeptide) (clinicaltrials.gov)
P1, N=101, Recruiting, Institut Curie | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
gemcitabine • paclitaxel • PEP-010
4ms
The first-in-class pro-apoptotic peptide PEP-010 is effective in monotherapy and in combination with paclitaxel on resistant ovarian adenocarcinoma cell models. (PubMed, Front Pharmacol)
Moreover, when used in combination with paclitaxel, one of the therapeutic options for recurrent ovarian carcinoma, PEP-010 showed a beneficial effect leading to the reduction of the IC50 of paclitaxel of 2.2 times and to apoptosis in 87% of cells. The described results suggest the potential therapeutic interest for PEP-010 and lead to the choice of ovarian adenocarcinoma as one of the major indications of the ongoing clinical trial.
Journal • Combination therapy
|
CASP9 (Caspase 9) • ANXA5 (Annexin A5)
|
paclitaxel • PEP-010
12ms
First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel or With Gemcitabine (CleverPeptide) (clinicaltrials.gov)
P1, N=87, Recruiting, Institut Curie | Active, not recruiting --> Recruiting | N=56 --> 87 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
gemcitabine • paclitaxel • PEP-010
1year
First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel (CleverPeptide) (clinicaltrials.gov)
P1, N=56, Active, not recruiting, Institut Curie | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Nov 2023
Enrollment closed • Trial primary completion date • Combination therapy • Metastases
|
paclitaxel • PEP-010
almost2years
The proapoptotic peptide PEP-010 is efficient on several models of different tumor origins and it can be monitored by pharmacodynamic biomarker candidates in clinical practice (AACR 2023)
We have compared specific features related to the mechanism-of-action of PEP-010 in sensitive (MDA-MB-231, IGROV1) and not sensitive cell models of different tumor origins and in tissue sections derived from Patient-Derived Xenografts models of breast cancer treated or not with PEP-010. Widely used techniques as immunofluorescent staining and immunohistochemistry were employed, making these results easily transferable in clinical routine.Taken together, our pre-clinical data showed the potential of PEP-010 as an anti-cancer peptide on a wide variety of malignancies and enabled the identification of pharmacodynamic biomarker candidates, important to ease the clinical development.
Clinical • PK/PD data
|
CASP3 (Caspase 3) • CASP9 (Caspase 9) • ANXA5 (Annexin A5)
|
PEP-010