Plus Therapeutics to Present Multi-Institutional Experience Using the CNSide™ Cerebrospinal Fluid Assay in Patients with Leptomeningeal Metastases
Plus Therapeutics will present data at the 2024 Society for NeuroOncology Annual Meeting showcasing their CNSide CSF Assay Platform's effectiveness in analyzing leptomeningeal metastases (LM). The study examined 258 CSF samples from 66 LM patients across five institutions.
The analysis revealed significant findings: 88% of patients showed biomarker changes through FISH analysis, with 26 new actionable biomarkers identified. Additionally, 20% of patients demonstrated biomarker changes through ICC analysis, discovering 7 new actionable biomarkers. The research evaluated 14 biomarkers total, with 12 showing changes during treatment.
These findings suggest dynamic mutation profiles in LM, highlighting potential implications for treatment strategies, particularly regarding radiotherapeutics like Rhenium Obisbemeda.
Plus Therapeutics presenterà dati al Congresso Annuale della Society for NeuroOncology del 2024, mostrando l'efficacia della loro Piattaforma di Assay del Liquido Cervello-Spinale CNSide nell'analisi delle metastasi leptomeningeali (LM). Lo studio ha esaminato 258 campioni di liquido cerebrospinale da 66 pazienti con LM in cinque istituzioni.
L'analisi ha rivelato risultati significativi: l'88% dei pazienti ha mostrato cambiamenti nei biomarcatori attraverso l'analisi FISH, con 26 nuovi biomarcatori actionable identificati. Inoltre, il 20% dei pazienti ha dimostrato cambiamenti nei biomarcatori tramite l'analisi ICC, scoprendo 7 nuovi biomarcatori actionable. La ricerca ha valutato un totale di 14 biomarcatori, di cui 12 hanno mostrato cambiamenti durante il trattamento.
Questi risultati suggeriscono profili dinamici di mutazione nelle LM, evidenziando potenziali implicazioni per le strategie terapeutiche, in particolare riguardo ai radioterapici come il Rhenium Obisbemeda.
Plus Therapeutics presentará datos en la Reunión Anual 2024 de la Society for NeuroOncology, mostrando la eficacia de su Plataforma de Ensayo de LCR CNSide en el análisis de metástasis leptomeníngeas (LM). El estudio examinó 258 muestras de LCR de 66 pacientes con LM en cinco instituciones.
El análisis reveló hallazgos significativos: el 88% de los pacientes mostró cambios en los biomarcadores a través del análisis FISH, identificándose 26 nuevos biomarcadores accionables. Además, el 20% de los pacientes demostró cambios en los biomarcadores mediante el análisis ICC, descubriendo 7 nuevos biomarcadores accionables. La investigación evaluó un total de 14 biomarcadores, de los cuales 12 mostraron cambios durante el tratamiento.
Estos hallazgos sugieren perfiles de mutación dinámicos en LM, destacando implicaciones potenciales para las estrategias de tratamiento, particularmente en relación con los radioterapéuticos como el Rhenium Obisbemeda.
플러스 테라퓨틱스(Plus Therapeutics)는 2024년 신경종양학회(Society for NeuroOncology) 정기회에서 CNSide 뇌척수액 검사 플랫폼의 뇌수막 전이증(Leptomeningeal Metastases, LM) 분석의 효과를 발표할 예정입니다. 이 연구는 5개 기관에서 66명의 LM 환자로부터 수집된 258개의 뇌척수액 샘플을 분석했습니다.
분석 결과는 중요한 발견을 이끌어냈습니다: 환자의 88%가 FISH 분석을 통해 바이오마커 변화가 있었으며, 26개의 새로운 실행 가능한 바이오마커가 발견되었습니다. 또한, 환자의 20%가 ICC 분석을 통해 바이오마커 변화가 있었고, 7개의 새로운 실행 가능한 바이오마커가 발견되었습니다. 연구는 총 14개의 바이오마커를 평가했으며, 이 중 12개는 치료 중에 변화가 발생했습니다.
이러한 발견은 LM에서 동적인 돌연변이 프로파일이 존재함을 시사하며, 특히 Rhenium Obisbemeda와 같은 방사선치료제와 관련하여 치료 전략에 대한 잠재적 함의를 강조합니다.
Plus Therapeutics présentera des données lors de la Réunion Annuelle 2024 de la Société d'Oncologie Neuro-Oncologique, mettant en évidence l'efficacité de leur Plateforme de Test LCR CNSide pour analyser les métastases leptomeningeales (LM). L'étude a examiné 258 échantillons de LCR provenant de 66 patients LM dans cinq établissements.
L'analyse a révélé des résultats significatifs : 88 % des patients ont montré des changements de biomarqueurs par l'analyse FISH, avec 26 nouveaux biomarqueurs exploitables identifiés. De plus, 20 % des patients ont démontré des changements de biomarqueurs grâce à l'analyse ICC, découvrant 7 nouveaux biomarqueurs exploitables. La recherche a évalué un total de 14 biomarqueurs, dont 12 ont montré des changements au cours du traitement.
Ces résultats suggèrent des profils de mutation dynamiques dans les LM, mettant en avant de potentielles implications pour les stratégies de traitement, notamment en ce qui concerne les radiotherapeutiques comme le Rhenium Obisbemeda.
Plus Therapeutics wird beim Jahrestreffen 2024 der Society for NeuroOncology Daten präsentieren, die die Wirksamkeit ihrer CNSide Liquor-Testplattform zur Analyse leptomeningealer Metastasen (LM) zeigen. Die Studie untersuchte 258 Liquorproben von 66 LM-Patienten an fünf Institutionen.
Die Analyse ergab signifikante Ergebnisse: 88% der Patienten zeigten Veränderungen der Biomarker durch die FISH-Analyse, wobei 26 neue umsetzbare Biomarker identifiziert wurden. Zusätzlich wiesen 20% der Patienten Veränderungen der Biomarker durch die ICC-Analyse auf, wobei 7 neue umsetzbare Biomarker entdeckt wurden. Die Forschung bewertete insgesamt 14 Biomarker, von denen 12 während der Behandlung Veränderungen zeigten.
Diese Ergebnisse deuten auf dynamische Mutationsprofile bei LM hin und heben potenzielle Implikationen für Behandlungsstrategien hervor, insbesondere im Hinblick auf Radiotherapeutika wie Rhenium Obisbemeda.
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CNSide Cerebrospinal Fluid (CSF) Assay analyzed 258 CSF samples across 66 leptomeningeal metastases (LM) patients at five institutions
CNSide identified extensive, actionable mutational changes, and clinically relevant longitudinal biomarkers
AUSTIN, Texas, Nov. 21, 2024 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), 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. The data will be presented at the 2024 Society for NeuroOncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“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
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
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential role of radiotherapeutics, including Rhenium (186Re) Obisbemeda, in addressing challenging diseases, such as Leptomeningeal Metastases, and predicted timeline of commercialization of the CNSide CSF tumor cell enumeration test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: reliance on third parties, including SpectronRx; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
chuang@plustherapeutics.com
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