JBZ-001 / Jabez Biosciences - LARVOL DELTA

Jabez Biosciences, Inc. Opens Second Clinical Site in Phase 1 Oncology Clinical Study of JBZ-001 (GlobeNewswire) - "The Phase 1 study is now open and enrolling patients at a second site, START Mountain Region....The phase 1 study is evaluating the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma (NHL)."

Trial status • Non-Hodgkin’s Lymphoma • Solid Tumor

Multi-institutional team awarded NCI grant to open novel AML trial (Eurekalert) - "The University of Cincinnati Cancer Center (UC), The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James) and Jabez Biosciences are partnering to open a new phase 1 clinical trial studying JBZ-001, a potential new treatment for acute myeloid leukemia (AML). The trial is supported by a more than $3.4 million grant from the National Institutes of Health’s National Cancer Institute awarded to UC and OSUCCC - James....The Phase 1 clinical study in AML will open at UC and OSU in 2026. This study aims to assess the safety, tolerability and preliminary efficacy of JBZ-001 in patients with AML."

Financing • New P1 trial • Acute Myelogenous Leukemia

Jabez Biosciences, Inc. Announced Phase 1 Clinical Trial of JBZ-001 at AACR 2025 (ACCESSWIRE) - "Jabez Biosciences...proudly shared the progress of its Phase 1 clinical trial for JBZ-001 (HOSU-53), a novel dihydroorotate dehydrogenase (DHODH) inhibitor, at the American Association for Cancer Research (AACR) Annual Meeting held April 25-30, 2025, in Chicago, IL....The Phase 1 study, underway at OSUCCC - James, aims to assess the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma. The trial's open-label design allows for real-time evaluation of the drug's effects, paving the way for future clinical development."

Trial status • Non-Hodgkin’s Lymphoma • Solid Tumor

Translational Pharmacokinetic-Pharmacodynamic Modeling of a Novel Oral Dihydroorotate Dehydrogenase (DHODH) Inhibitor, HOSU-53 (JBZ-001). (PubMed, Pharmaceutics) - "Additionally, predicted human hepatocellular HOSU-53 concentrations were obtained from a physiologically based PK model constructed in PK-Sim. A first-in-human starting dose of 5 mg once daily was established from the model approaches and will be utilized in the upcoming FIH clinical study."

Journal • PK/PD data • Oncology

An open-label phase 1 study to investigate JBZ001 in adults with advanced solid tumors and non-Hodjkin lymphoma (JBZ001, trial in progress) (AACR 2025) - "Safety and antitumor activity endpoints will be summarized using descriptive statistics. Recruitment is ongoing for Part 1 at The Ohio State University Comprehensive Cancer Center (WCG IRB 20245148)."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastric Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Small Cell Lung Cancer • Solid Tumor

AACR 2025: Colon Cancer Risk Reduction, Predicting Melanoma Spread and New Drug Therapies Among Ohio State Findings (Newswise) - "The study focuses on a new drug called JBZ-001 (HOSU-53 when in preclinical testing), which was developed and then moved to commercialization at the OSUCCC - James. The trial represents the first human testing of a best-in-class DHODH inhibitor for stopping growth of various cancers, including certain lymphomas. This clinical trial is now enrolling patients with advanced solid tumors or lymphomas that have not responded to other treatments....When tested in preclinical models, HOSU-53 helped slow the growth of cancer cells. Study findings suggest a new possible way to treat small cell lung cancer and have led to starting human trials to see if HOSU-53 works well in people and if it is safe to use."

Preclinical • Trial status • Lymphoma • Solid Tumor

Jabez Biosciences, Inc. Announces First Patient Dosed in Phase 1 Oncology Clinical Study of JBZ-001 (ACCESSWIRE) - "Jabez Biosciences...announced that the first patient has been successfully dosed in its Phase 1 clinical study of JBZ-001, a next-generation small molecule inhibitor targeting dihydroorotate dehydrogenase (DHODH). This milestone marks a significant step forward in the company's mission to develop innovative treatments that improve and extend the lives of patients battling cancer....The Phase 1 study, conducted at The Ohio State University Comprehensive Cancer Center...is evaluating the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma (NHL)."

Trial status • Non-Hodgkin’s Lymphoma • Solid Tumor

Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Jabez Bioscience, Inc

New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor