PEP-010 / PEP-Therapy - LARVOL DELTA

The pro-apoptotic peptide PEP-010 triggers apoptosis in pancreatic tumor models in monotherapy and in combination with gemcitabine independently of the KRAS status. (PubMed, Cancer Lett) - No abstract available

Journal • Monotherapy • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

PEP-Therapy receives FDA Orphan Drug Designation for PEP-010 for treatment of Pancreatic Cancer (GlobeNewswire) - "PEP-Therapy...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its flagship product, PEP-010, for the treatment of pancreatic cancer. PEP-010, PEP-Therapy’s first-in-class bifunctional therapeutic peptide is being studied in an ongoing Phase Ib clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary anti-tumor activity, in combination with chemotherapy (paclitaxel or gemcitabine), in particular in patients with pancreatic cancer."

Orphan drug • Pancreatic Cancer

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 | Sponsor: Institut Curie | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jul 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A translational study for biomarker identification of PEP-010, a pro-apoptotic peptide restoring apoptosis in cancer models. (PubMed, Biochim Biophys Acta Mol Basis Dis) - No abstract available

Biomarker • Journal • Preclinical • Review • Breast Cancer • Oncology • Solid Tumor

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."

Combination therapy • Journal • Monotherapy • Colorectal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • ANXA5 • CASP9

The first-in-class proapoptotic peptide PEP-010 is effective in monotherapy and in combination with Paclitaxel on resistant ovarian adenocarcinoma cell models (Front Pharmacol) - "We show here that PEP-010 effectively induces cell death in monotherapy in up to 55% of cells from ovarian adenocarcinoma cell models resistant to different chemotherapies. 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."

Preclinical • Ovarian Cancer

PP2A triggers the cell death signaling cascade after treatment with PEP-010, a first-in-class clinical-stage pro-apoptotic peptide (EACR 2024) - "Moreover, it paves the way to further in vivo studies which could grant for a possible extension of the therapeutic indication in PEP-010 clinical development. If conclusive, PEP-010 could represent a valid therapeutic opportunity for Venetoclax-resistant populations."

Clinical • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • ANXA5 • CASP9

PEP-010, a first-in-class clinical-stage pro-apoptotic peptide is efficient in vitro and in ovo on pancreatic cancer in monotherapy and in combination with different chemotherapies (EACR 2024) - "We also demonstrated through both in vitro and in ovo experiments that combining PEP-010 with standard chemotherapies such as gemcitabine results in an additive effect significantly superior to individual effects of the monotherapies. We have also observed in vitro a beneficial effect of using PEP-010 in combination with paclitaxel.Conclusion These preclinical data together with observed preliminary signal of antitumoral activity in one PC patient in combination with paclitaxel during the clinical trial dose-escalation phase (Phase Ia), support the clinical trial strategy and highlights the therapeutic interest of PEP-010 for this hard-to-treat disease."

Combination therapy • Monotherapy • Preclinical • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • ANXA5 • CASP3 • CASP9

PEP-Therapy and Institut Curie Announce First Patients Dosed in Phase Ib Clinical Trial Evaluating PEP-010 in Ovarian and Pancreatic Cancers (GlobeNewswire) - "PEP-Therapy...announced the dosing of the first patients in a Phase Ib clinical trial evaluating PEP-Therapy’s lead candidate, PEP-010, based on highly encouraging Phase Ia results. This second part ot the Phase I study is evaluating PEP-010 in combination with chemotherapy (paclitaxel or gemcitabine), in advanced or metastatic ovarian cancer (OC) and in metastatic pancreatic ductal adenocarcinoma (PDAC), two indications with high unmet medical need."

Trial status • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma

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 | Sponsor: Institut Curie | Active, not recruiting ➔ Recruiting | N=56 ➔ 87 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Nov 2023 ➔ Dec 2024

Combination therapy • Enrollment change • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

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 | Sponsor: Institut Curie | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Nov 2023

Combination therapy • Enrollment closed • Metastases • Trial primary completion date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A first-in-human Phase 1a/b of PEP-010, a proapoptotic bifunctional peptide, administered as single agent and in combination with paclitaxel in patients with recurrent and/or metastatic solid cancer: results from the dose escalation study. (AACR-NCI-EORTC 2023) - No abstract available

Clinical • Combination therapy • Metastases • P1 data • Oncology • Solid Tumor

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."

Biomarker • Clinical • PK/PD data • Breast Cancer • Oncology • Solid Tumor • ANXA5 • CASP3 • CASP9

PEP-Therapy and Institut Curie announce first patients dosed in Phase I clinical trial of PEP-010 for the treatment of advanced solid tumors (PRNewswire) - "PEP-Therapy...announce that the first patients have been dosed in a Phase Ia/b multicenter clinical trial evaluating PEP-Therapy's lead candidate, PEP-010. In this first-in-human trial, PEP-010 is being administered in patients with advanced solid tumors...'We look forward to announcing the preliminary safety and tolerability data in 2022'...The study will also be conducted at two other clinical oncology centers, Gustave Roussy and the François Baclesse Center, where patients will receive the next dose levels."

P1 data • Trial status • Oncology • Solid Tumor

PEP-Therapy extends Series-A financing, raising a total of €5.4 million to progress the clinical development of its lead candidate PEP-010 (PRNewswire) - "PEP-Therapy...announced today that it raised an additional €2.6 million ($3 million) in an extension of its Series A financing round, bringing the total raised in this round to €5.4 million ($6.4 million). This new funding comprises €1.6 million in equity from Anaxago, i&i Prague and BADGE as well as a €1 million loan from Bpifrance....PEP-Therapy will use the funds to finance the Phase I a/b clinical trial of PEP-010, PEP-Therapy's lead candidate, for the treatment of advanced solid tumors. The first part of the Series A, which closed in April 2021, will finance the Phase Ia dose escalation part of the study, with the additional funds being used for the development of PEP-010 until the end of the expansion cohorts, Phase Ib."

Financing • Oncology • Solid Tumor

First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel (CleverPeptide) (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Institut Curie; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

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; Sponsor: Institut Curie; Not yet recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

PEP-Therapy raises €2.75 million in Series A financing to advance its lead candidate, PEP-010, into the clinic (PRNewswire) - "PEP-Therapy...announces it has raised a €2.75 million in a Series A financing round....The financing round is complemented by a €2.9 million grant from the French state innovation fund - Fonds Unique Interministériel (FUI)...to develop PEP-010 up to the end of Phase Ia/b clinical trials...With this Series A funding, PEP-Therapy expects to generate promising Phase Ia/b clinical data in two indications where patients have a poor prognosis and limited therapeutic alternatives: triple negative breast cancer (TNBC) and the platinum resistant ovarian cancer (OC)."

Financing • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Triple Negative Breast Cancer

PEP-Therapy and Institut Curie granted approval from ANSM to start first-in-human clinical trial of PEP-010 for the treatment of advanced solid tumors (PRNewswire) - "PEP-Therap...announce that they have been granted approval from the French National Agency for Medicines and Health Products (ANSM) to proceed with the first-in-human clinical trial of PEP-Therapy's lead drug candidate, PEP-010...The clinical trial, named 'CleverPeptide', is an open-label, non-controlled, multicenter, dose escalation, Phase I clinical trial with an expansion Phase. This Phase Ia/b study has been designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of intravenous PEP-010, administered as a single agent and in combination with paclitaxel in patients with recurrent and/or metastatic solid tumors, and in particular in Triple Negative Breast Cancer (TNBC) and Ovarian Cancer (OC)."

European regulatory • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel (CleverPeptide) (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: Institut Curie

Clinical • Combination therapy • New P1 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer