Core Viewpoint - Plus Therapeutics has initiated the ReSPECT-LM dose optimization trial for REYOBIQ™ to determine the optimal dosing schedule for treating leptomeningeal metastases, building on previous trial results and supported by a $17.6 million grant from CPRIT [1][7]. Trial Design and Objectives - The trial aims to optimize treatment dosing for maximum efficacy and safety, focusing on the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter [2]. - Primary objectives include identifying the maximum tolerated dose and minimum effective dose for patients with LM from any primary solid tumor cancer [2]. Enrollment and Study Details - The trial will enroll up to 24 patients, evaluating REYOBIQ at a recommended Phase 2 dose of 44.1 mCi across three dosing intervals [4]. - Key cohorts include dosing intervals of 56 days, 28 days, and 14 days, with up to six patients per cohort [4]. Efficacy and Safety Data - Previous trials showed a clinical benefit rate of 76%, with 29% of patients achieving partial responses and 47% maintaining stable disease [5]. - No dose-limiting toxicities were observed in the first four cohorts, although one Grade 4 DLT occurred in each of Cohorts 5 and 6 [5]. Future Plans - The company plans to present data from the completed single-dose escalation trial at the SNO/ASCO CNS Metastases Conference in August 2025 and will request an End of Phase 1 Type B meeting with the FDA [6]. About Leptomeningeal Metastases - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, with median survival typically ranging from 2 to 6 months, highlighting the urgent need for effective treatment options [8]. About REYOBIQ™ - REYOBIQ™ is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, with potential advantages over currently approved therapies [9]. Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes treatments for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancer [10].

Core Insights - Plus Therapeutics has received FDA clearance for its Investigational New Drug application for REYOBIQ, aimed at treating pediatric patients with high-grade glioma and ependymoma [2][5] - The Phase 1/2a trial, named ReSPECT-PBC, is supported by a $3 million grant from the U.S. Department of Defense and will focus on determining the maximum tolerated dose and safety of REYOBIQ in children aged 6 to 21 [1][4][7] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, specializing in targeted radiotherapeutics for central nervous system cancers [9] - The company is advancing a pipeline that includes treatments for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer [9] Trial Design and Objectives - The ReSPECT-PBC trial is a two-part, single-arm study designed to assess the safety and tolerability of REYOBIQ, with a focus on pediatric patients with rare and aggressive brain tumors [4][7] - The trial will enroll approximately 56 patients, with 24 in Phase 1a for dose escalation and 32 in Phase 2a to assess efficacy [7] Treatment Potential - REYOBIQ is designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue, potentially improving outcomes for patients with limited treatment options [5][8] - The targeted delivery method via convection enhanced delivery (CED) aims to bypass the blood-brain barrier, which is a significant challenge in treating CNS tumors [4][5]

Core Insights - ASP Isotopes Inc. and Isotopia Molecular Imaging Ltd. have formed a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), essential for producing Terbium-161 (Tb-161), a promising medical isotope for targeted radiotherapeutics [1][2] Group 1: Partnership Details - The partnership aims to resolve supply challenges for Gd-160, facilitating the advancement of Tb-161-based therapies for various cancers, including prostate cancer and neuroendocrine tumors [2] - ASP Isotopes will utilize its proprietary Quantum Enrichment technology to provide enriched Gd-160, which is crucial for Tb-161 manufacturing [3] - The collaboration combines ASP Isotopes' large-scale isotope enrichment expertise with Isotopia's capabilities in commercial-scale medical isotope production [3] Group 2: Strategic Importance - The agreement is significant as it eliminates a major bottleneck in the development of Tb-161 therapies, supporting the growing demand for stable isotopes in the radiopharmaceutical industry [4] - Tb-161's dual mechanism of action allows for precise targeting of cancer cells while minimizing damage to healthy tissues, aligning with the oncology field's shift towards targeted radiotherapeutics [4] Group 3: Company Profiles - ASP Isotopes specializes in advanced isotope separation technologies, focusing on producing and commercializing highly enriched isotopes for healthcare and technology [5] - Isotopia is a global leader in medical isotope production, with facilities in Israel, Europe, and the U.S., and collaborates with researchers to develop novel radiopharmaceuticals [6] Group 4: Industry Outlook - This partnership positions both companies at the forefront of the radiopharmaceutical revolution, potentially expanding treatment options for cancer patients globally [7]

Core Viewpoint - Plus Therapeutics, Inc. has received a delinquency notification from Nasdaq due to the delayed filing of its Quarterly Report for the period ended March 31, 2025, but this does not immediately affect its listing status on Nasdaq [1][2]. Group 1: Compliance and Filing Status - The Company must submit a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) by July 21, 2025 [2]. - If the compliance plan is accepted, Nasdaq may grant an extension of up to 180 calendar days, allowing the Company until November 17, 2025, to regain compliance [2]. - The Company is actively working to file the Quarterly Report as soon as possible and aims to return to a normal filing schedule for the remainder of 2025 [2]. Group 2: Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for challenging cancers of the central nervous system [3]. - The Company employs a combination of image-guided local beta radiation and targeted drug delivery methods, with key programs targeting leptomeningeal metastases and recurrent glioblastoma [3]. - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [3].

Core Insights - Plus Therapeutics presented new data on its lead drug REYOBIQ™ at the Nuclear Medicine and Neurooncology Conference, highlighting its potential in treating Leptomeningeal Metastases (LM) [1][2] Group 1: REYOBIQ™ Data Presentation - The data indicates safety and clinical benefits of REYOBIQ in patients with LM, with multiple doses administered under compassionate use contributing to long-term survival [2] - The study titled "Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases" provides additional insights from the completed Phase 1 ReSPECT-LM dose escalation trial [2] Group 2: Leptomeningeal Metastases Overview - LM is a rare but severe complication of cancer, affecting approximately 5% of cancer patients, with a notably low 1-year survival rate of 7% and a 2-year survival rate of 3% [4] - The incidence of LM is increasing, partly due to longer cancer patient lifespans and the ineffectiveness of standard chemotherapies in reaching sufficient concentrations in the cerebrospinal fluid [4] Group 3: REYOBIQ™ Mechanism and Efficacy - REYOBIQ™ is designed to deliver targeted high-dose radiation to CNS tumors, potentially improving outcomes compared to existing therapies [5] - The study reported a dose-dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space, reaching 253 Gy in Cohort 5 [6] - Clinical benefit rates were high, with 76% of patients showing complete response, partial response, or stable disease, and 87% demonstrating clinical response based on physician evaluation [6] Group 4: Clinical Trials and Funding - REYOBIQ™ is being evaluated in clinical trials for recurrent glioblastoma and leptomeningeal metastases, with funding support from the National Cancer Institute and a $17.6 million grant from the Cancer Prevention & Research Institute of Texas [7]

HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. The Company’s common stock will continue to be listed and ...

Core Insights - Rhenium (Re) Obisbemeda shows promising safety and efficacy for glioblastoma patients, with a median overall survival of 17 months for those receiving doses greater than 100 Gy, compared to 8 months with standard care [1][7] - The publication of Phase 1 trial results in a high-impact journal validates the clinical program and supports the ongoing ReSPECT-GBM Phase 2 trial [2] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, particularly recurrent glioblastoma and leptomeningeal metastases [9] - The company utilizes advanced platform technologies to enhance patient outcomes through targeted drug delivery and image-guided local beta radiation [9] Clinical Trial Details - The ReSPECT-GBM trial is currently enrolling patients and aims to provide a much-needed treatment option for recurrent glioblastoma, which has limited existing therapies [2][3] - Rhenium (Re) Obisbemeda is being evaluated in clinical trials, including ReSPECT-GBM and ReSPECT-LM, with significant funding support from the National Cancer Institute and a $17.6 million grant from the Cancer Prevention & Research Institute of Texas [5] Disease Context - Glioblastoma affects approximately 15,000 patients annually in the U.S. and is characterized by a poor prognosis, with an average life expectancy of less than 24 months [4] - Current treatments for recurrent glioblastoma offer marginal survival benefits and are associated with significant side effects, highlighting the need for more effective therapies [4] Treatment Mechanism - Rhenium (Re) Obisbemeda is a novel injectable radiotherapy designed to deliver high doses of targeted radiation directly to CNS tumors, potentially improving outcomes compared to existing therapies [5] - The treatment utilizes Rhenium-186, which has a short half-life and is effective for both destroying cancerous tissue and real-time imaging [5]