PEP07 / PharmaEngine, Sentinel Oncology - LARVOL DELTA

A multicenter phase I study of PEP07 (Chk1i) to evaluate safety, tolerability, and pharmacokinetics in patients with advanced or metastatic solid tumors (ESMO 2025) - P1 | "Legal entity responsible for the study PharmaEngine Inc. Funding PharmaEngine Inc."

Clinical • Metastases • P1 data • PK/PD data • Brain Cancer • Oncology • Solid Tumor • ATR • CHEK1 • GNRP • RASGRF1

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: PharmaEngine | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

Preclinical and clinical studies of PEP07, a novel brain penetrating Chk1 inhibitor, on solid tumor treatments (AACR 2025) - P1 | "Patient-derived tumor cells (PDCs) were used to validate the prediction of sensitive cells by ANN models.PEP07 is currently being evaluated in clinical studies for both hematologic and solid cancers. PEP07-102 (NCT05983523), a Phase 1, open-label, multi-center PK/PD and dose-escalation study employs an accelerated titration design combined with a traditional 3+3 approach assessing PEP07 as monotherapy in patients with advanced or metastatic solid tumors."

Preclinical • Brain Cancer • Oncology • Solid Tumor

Preclinical and clinical studies of PEP07, a novel brain penetrating oral Chk1 inhibitor, on AML and MCL treatments (AACR 2025) - P1 | "It also showed enhanced tumor growth inhibition in the cytarabine-resistant AML xenograft model when combined with cytarabine.PEP07 is currently being evaluated in clinical studies for both hematologic and solid cancers. This study is ongoing in multiple countries and evaluates oral PEP07 as monotherapy for AML and MCL. With its ability to penetrate the blood-brain barrier (BBB), PEP07 is also being considered for investigating treatment options for brain cancer in clinical settings."

Preclinical • Acute Myelogenous Leukemia • Brain Cancer • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CCND1 • CDK1

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: PharmaEngine | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Aug 2027 | Trial primary completion date: Jul 2026 ➔ Feb 2027

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: PharmaEngine | Phase classification: P1b ➔ P1

Metastases • Phase classification • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: PharmaEngine

Metastases • New P1 trial • Oncology • Solid Tumor

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer (clinicaltrials.gov) - P1b | N=32 | Recruiting | Sponsor: PharmaEngine | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer (clinicaltrials.gov) - P1b | N=32 | Not yet recruiting | Sponsor: PharmaEngine

New P1 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

PharmaEngine, Inc. and Sentinel Oncology Limited Enter into an Exclusive Collaboration and License Agreement for SOL-578, a Chk1 inhibitor (PRNewswire) - “PharmaEngine, Inc…announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578, a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578….Under the terms of the Agreement, Sentinel Oncology will receive an exclusivity payment and PharmaEngine will obtain an option to receive the exclusive rights to develop and commercialize SOL-578 worldwide.”

Licensing / partnership • Oncology