On November 21, 2024 CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), reported it will present data demonstrating the utility of the CNSide CSF Assay Platform in identifying mutations of key biomarkers in the CSF and their implications in treatment selection for LM (Press release, Plus Therapeutics, NOV 21, 2024, View Source [SID1234648555]). The data will be presented at the 2024 Society for NeuroOncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
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"The data from CNSide suggests that biomarker mutation profiles in LM are dynamic, offering valuable insights for treatment strategies," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "The genetic drift observed in LM suggests an important role for radiotherapeutics such as Rhenium (186Re) Obisbemeda in addressing this challenging disease."
Key highlights:
CNSide CSF Assay evaluated 258 CSF samples across 66 patients with LM to analyze clinically relevant biomarkers
Fourteen biomarkers were assessed, including 11 by fluorescent in situ hybridization (FISH) and 3 by immunocytochemistry (ICC); 12 of the 14 biomarkers demonstrated at least one change during treatment
CNSide CSF FISH analysis detected biomarker changes in 88% (58/66) of patients, with newly identified actionable biomarkers in 26 cases
CNSide CSF ICC analysis revealed biomarker changes in 20% (13/66) of patients, with newly identified actionable biomarkers in 7 cases
The data will be presented on Friday, November 22, at 7:30 p.m. CST in a session titled, "The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor," by Arushi Tripathy, M.D., from University of Michigan Department of Neurosurgery.
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary clinical diagnostic laboratory assays, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the clinical management of patients with leptomeningeal metastases. The Company is planning to commercialize CNSide in the U.S. in 2025.
About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint and is currently anticipated to become commercially available in 2025.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).