On February 14, 2023 Quadriga BioSciences, a clinical-stage oncology company developing QBS10072S (QBS72S) for the targeted treatment of cancer, reported the dosing of the first subject with QBS72S in the Phase 2 INSIGhT study, evaluating QBS72S against the standard of care (temozolomide) for the potential treatment of newly diagnosed glioblastoma (Press release, Quadriga BioSciences, FEB 14, 2023, View Source [SID1234627218]).
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"The initiation of QBS72S dosing in the Phase 2 study with Dana-Farber Cancer Institute represents a significant milestone for Quadriga," said Gordon Ringold, Ph.D., Chief Executive Officer of Quadriga BioSciences. "The treatment of glioblastoma is a significant unmet clinical need. QBS72S represents an innovative therapeutic modality in this field that has the potential to overcome current limitations. We look forward to investigating this more closely with our colleagues at Dana-Farber."
Glioblastoma (GBM) is an aggressive form of brain cancer that affects more than 13,000 people annually in the United States. Temozolomide (TMZ), approved by the U.S. Food and Drug Administration (FDA) for the treatment of GBM in 2005, remains the current standard of care. TMZ modifies DNA to trigger cell death; however, an estimated 60% of GBM patients express an enzyme, O-6-methylguanine-DNA methyltransferase (MGMT), that repairs the damaged DNA, leading to TMZ drug resistance and an average survival of 5-6 months from time of diagnosis. QBS72S is designed to treat GBM, even in patients who are resistant to TMZ.
In GBM animal models, QBS72S successfully delayed tumor growth and extended survival. In the completed Phase 1 study, QBS72S showed preliminary evidence of clinical benefit in previously treated/refractory GBM patients.
"Glioblastoma is the most malignant form of brain cancer and there is a desperate need for better treatments," said Patrick Y. Wen, M.D., Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Director of the Division of Cancer Neurology in the Department of Neurology at Brigham and Women’s Hospital and Principal Investigator of the Phase 2 clinical study. "As QBS72S can cross the blood brain barrier and is designed to impact TMZ resistant glioblastomas, we are looking forward to the opportunity to study this agent."
The Phase 2 study is funded by a Small Business Innovation Grant (SBIR).
About QBS72S
QBS72S is a novel, first-in-class chemotherapeutic agent that mimics an aromatic amino acid for cellular uptake by the amino acid transporter LAT1 (L-type amino acid transporter 1) thereby enabling the drug to cross the blood brain barrier (BBB) as well as to selectively target numerous types of rapidly growing cancer cells. Once inside the cell QBS72S causes double-stranded DNA breaks resulting in cell death. Most aggressive cancers express high LAT1, which is commonly associated with poor prognoses.1
About the INSIGhT Trial
The INSIGhT trial is a Phase 2 trial comparing novel agents with standard of care temozolomide in newly diagnosed glioblastoma patients. The current trial includes four investigational agents: abemaciclib, CC115, neratinib and QBS72S. QBS72S will be administered intravenously along with radiation treatment on day 1 of the treatment cycle. Please refer to www.clinicaltrials.gov [NCT02977780] for additional clinical trial details.