Delving into the Latest Updates on Esperance Pharmaceuticals, Inc. with Synapse

Overview

Tags

Neoplasms

Skin and Musculoskeletal Diseases

Antibody drug conjugate (ADC)

Recombinant polypeptide

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	2

Top 5 Drug Type	Count

Antibody drug conjugate (ADC)	1
Recombinant polypeptide	1

Top 5 Target	Count

NCL(Nucleolin)	1

Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.

Start Date01 Feb 2012

Sponsor / Collaborator

Esperance Pharmaceuticals, Inc.

NCT00949559 / CompletedPhase 1

A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of EP-100 Given Intravenously 3 Out of 4 Weeks in Subjects With Advanced Solid Tumors

This study is being done to:
Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
Find the highest dose of EP-100 that can be given without causing bad side effects;
Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it;
Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.

Start Date01 Jul 2009

Sponsor / Collaborator

Esperance Pharmaceuticals, Inc.

100 Clinical Results associated with Esperance Pharmaceuticals, Inc.

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0 Patents (Medical) associated with Esperance Pharmaceuticals, Inc.

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10

Literatures (Medical) associated with Esperance Pharmaceuticals, Inc.

01 Feb 2021·Gynecologic OncologyQ2 · MEDICINE

A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer

Q2 · MEDICINE

Article

Author: Gordinier, Mary ; Leuschner, Carola ; Chelariu-Raicu, Anca ; Bavisotto, Linda ; Nick, Alpa ; Molin, Graziela Zibetti Dal ; Coleman, Robert L ; Urban, Renata ; Whisnant, John K

OBJECTIVEThis randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor.METHODSIn a limited "run-in" dose escalation phase for EP-100, six patients were treated with ascending dose levels (13 mg/m², 20 mg/m², 30 mg/m²). In the randomized phase, patients received weekly paclitaxel (80 mg/m² intravenously) plus twice weekly EP-100 (30 mg/m² intravenously; combination arm) or weekly paclitaxel alone (80 mg/m² intravenously; paclitaxel arm). The primary study endpoint was overall response rate (ORR).RESULTSForty-four patients were then randomized to either the experimental combination arm (n = 23) or the standard of care paclitaxel monotherapy arm (n = 21). The ORR was 35% (95%CI 16%-57%) for the combination arm and 33% (95% CI 15%-57%) for the paclitaxel arm. An interesting observation from an unplanned analysis was that a subset of patients with target liver lesions showed a greater overall response rate to the combination (69%) compared to paclitaxel alone (16%). The frequency of treatment-related grade 3-4 adverse events was similar between treatment arms: 48% vs 43% for the combination and paclitaxel arms, respectively.CONCLUSIONSORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone; however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-100 did not appear to augment the adverse event profile of paclitaxel and was well tolerated.

01 May 2019·Molecular Cancer TherapeuticsQ2 · MEDICINE

GnRH-R–Targeted Lytic Peptide SensitizesBRCAWild-type Ovarian Cancer to PARP Inhibition

Q2 · MEDICINE

Article

Author: Rodriguez-Aguayo, Cristian ; Wu, Sherry Y. ; Leuschner, Carola ; Schlacher, Katharina ; Sood, Anil K. ; Liang, Xiaoyan ; Pradeep, Sunila ; Ram, Prahlad T. ; Hu, Wei ; Villar-Prados, Alejandro ; Bayraktar, Emine ; Kim, Mark Seungwook ; Ma, Shaolin ; Mangala, Lingegowda S. ; Coleman, Robert L. ; Wen, Yunfei

AbstractEP-100 is a synthetic lytic peptide that specifically targets the gonadotropin-releasing hormone receptor on cancer cells. To extend the utility of EP-100, we aimed to identify effective combination therapies with EP-100 for ovarian cancer and explore potential mechanisms of this combination. A series of in vitro (MTT assay, immunoblot analysis, reverse-phase protein array, comet assay, and immunofluorescence staining) and in vivo experiments were carried out to determine the biological effects of EP-100 alone and in combination with standard-of-care drugs. EP-100 decreased the viability of ovarian cancer cells and reduced tumor growth in orthotopic mouse models. Of five standard drugs tested (cisplatin, paclitaxel, doxorubicin, topotecan, and olaparib), we found that the combination of EP-100 and olaparib was synergistic in ovarian cancer cell lines. Further experiments revealed that combined treatment of EP-100 and olaparib significantly increased the number of nuclear foci of phosphorylated histone H2AX. In addition, the extent of DNA damage was significantly increased after treatment with EP-100 and olaparib in comet assay. We performed reverse-phase protein array analyses and identified that the PI3K/AKT pathway was inhibited by EP-100, which we validated with in vitro experiments. In vivo experiment using the HeyA8 mouse model demonstrated that mice treated with EP-100 and olaparib had lower tumor weights (0.06 ± 0.13 g) than those treated with a vehicle (1.19 ± 1.09 g), EP-100 alone (0.62 ± 0.78 g), or olaparib alone (0.50 ± 0.63 g). Our findings indicate that combining EP-100 with olaparib is a promising therapeutic strategy for ovarian cancer.

20 May 2015·Journal of Clinical Oncology

EP-100 + paclitaxel to overcome taxane resistance in patients with recurrent LHRH-receptor expressing ovarian cancer.

Author: Rado, Thomas ; Bavisotto, Linda M. ; Gordinier, Mary E ; Urban, Renata ; Leuschner, Carola ; Whisnant, John ; Nick, Alpa Manchandia ; Coleman, Robert L.

5582 Background: EP-100 (E) is a synthetic cytolytic peptide conjugated to Luteinizing Hormone Releasing Hormone (LHRH). It targets cells that overexpress LHRH receptors and kills by membrane disru...

100 Deals associated with Esperance Pharmaceuticals, Inc.

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100 Translational Medicine associated with Esperance Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 20 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

2

6

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

EP-302 ( NCL )	Neoplasms More	Preclinical
EP-400	Neoplasms More	Preclinical
EP-300	Solid tumor More	Pending
EP-4XX	Hematologic Neoplasms More	Pending
EP-342	Neoplasms More	Pending