Reyobiq (rhenium Re186 obisbemeda) / NanoTx Therap, Cerenome - LARVOL DELTA

Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Cerenome | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2027 ➔ Mar 2028 | Trial primary completion date: Mar 2027 ➔ Mar 2028

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • Ependymoma • Glioma • High Grade Glioma • Oligodendroglioma • Oncology • Pediatrics • Solid Tumor

CA2024-LM-001: Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Cerenome | Phase classification: P1 ➔ P1/2

Phase classification • Oncology • Solid Tumor

The ReSPECT-GBM™ phase I/IIa trial of rhenium-186 nanoliposome (186RNL) in recurrent glioma via convection enhanced delivery (CED) and planned phase IIb trial (ESMO 2022) - "A RP2D of 22.3mCi/8.8mL was selected for patients with tumors of up to 15mL in the PIIb trial planned for 2022. The PIIb trial design and comparative survival data (synthetic control arm) will also be presented."

P1/2 data • P2b data • Brain Cancer • Glioma • Oncology • Solid Tumor

Radiation Absorbed Dose to Spinal Cord: Therapy of Leptomeningeal Metastasis Using Beta-Emission Radiopharmaceuticals (SNMMI 2024) - "In recent years, the beta-emission radiopharmaceuticals, for example, 131I-antibody and 186Re-nanoliposomes (186RNL), have been studied for the treatment of this disease... The radiation dosimetry study has shown that beta-emission radiopharmaceuticals with lower beta-energies are optimal for the treatment of LM. The dosimetry study results provide the guidance for the possible doses to be applied for the safe treatment of LM, including patients with previous external beam radiation therapy to the spine. While large radiation absorbed dose can be used, a multidose treatment strategy may be applied for long term effective tumor control."

Breast Cancer • Melanoma • Oncology • Solid Tumor

Phase 1 Study of WBRT or PCSI With REYOBIQ for Leptomeningeal Metastases (clinicaltrials.gov) - P1 | N=29 | Not yet recruiting | Sponsor: NYU Langone Health

New P1 trial • Oncology • CTCs

PSTV Gains FDA Orphan Status for Malignant Glioma Treatment (Gurufocus) - "The company is working on a range of potential products, with its main programs targeting recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). One of its key candidates, rhenium (186Re) obisbemeda, is specifically designed to treat central nervous system (CNS) cancers such as GBM, LM, and pediatric brain cancers (PBC)."

Orphan drug • Glioblastoma

Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ for Leptomeningeal Metastases (GlobeNewswire) - "Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year....FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint....FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application."

Clinical protocol • FDA event • Brain Cancer • CNS Tumor

Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Phase 1 dose escalation study results (SABCS 2025) - "Reyobiq shows excellent safety and promising activity for LM. A single dose for patients with LM was well-tolerated up to the RP2D of 44.10 mCi, with high absorbed doses to the treatment area, acceptable organ doses, and encouraging response and reductions in tumor cell count. Within the breast cancer patients, response rate and survival were also promising."

P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer • ER • HER-2 • PGR

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 (WFNOS 2025) - "Rhenium (186Re) Obisbemeda (186RNL; Reyobiq), a novel radiotherapeutic consisting of 186Re encapsulated in nanoliposomes, is under investigation for convection enhanced delivery in recurrent glioblastoma (GBM) in the Phase 1/2 ReSPECT-GBM trial (IND 116117)...Preliminary efficacy data from Phase 1 cohorts 1 to 6 (N=21) showed a median overall survival (mOS) of 17.0 months (95% CI 8.0–35.0) for patients receiving ≥100 Gy (n=12), compared to 6.0 months (95% CI 1.0–11.0) for those receiving <100 Gy (N=9), surpassing historical bevacizumab monotherapy outcomes (mOS ~7.4–9.2 months)...SPECT/CT imaging confirms high tumor-specific radiation retention, with minimal systemic exposure. These results support Reyobiq’s promising safety and efficacy profile, warranting further investigation as a novel therapeutic for recurrent GBM, addressing a critical unmet medical need."

Clinical • P1/2 data • P2 data • Brain Cancer • CNS Disorders • Cognitive Disorders • Developmental Disorders • Glioblastoma • Glioma • Oncology • Solid Tumor

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 (WFNOS 2025) - P1/2 | "Rhenium (186Re) Obisbemeda (186RNL; Reyobiq), a novel radiotherapeutic consisting of 186Re encapsulated in nanoliposomes, is under investigation for convection enhanced delivery in recurrent glioblastoma (GBM) in the Phase 1/2 ReSPECT-GBM trial (IND 116117)...Preliminary efficacy data from Phase 1 cohorts 1 to 6 (N=21) showed a median overall survival (mOS) of 17.0 months (95% CI 8.0–35.0) for patients receiving ≥100 Gy (n=12), compared to 6.0 months (95% CI 1.0–11.0) for those receiving <100 Gy (N=9), surpassing historical bevacizumab monotherapy outcomes (mOS ~7.4–9.2 months)...SPECT/CT imaging confirms high tumor-specific radiation retention, with minimal systemic exposure. These results support Reyobiq’s promising safety and efficacy profile, warranting further investigation as a novel therapeutic for recurrent GBM, addressing a critical unmet medical need."

Clinical • P1/2 data • P2 data • Brain Cancer • CNS Disorders • Cognitive Disorders • Developmental Disorders • Glioblastoma • Solid Tumor

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 (SNO 2025) - "Rhenium (186Re) Obisbemeda (186RNL; Reyobiq), a novel radiotherapeutic consisting of 186Re encapsulated in nanoliposomes, is under investigation for convection enhanced delivery in recurrent glioblastoma (GBM) in the Phase 1/2 ReSPECT-GBM trial (IND 116117)...Preliminary efficacy data from Phase 1 cohorts 1 to 6 (N=21) showed a median overall survival (mOS) of 17.0 months (95% CI 8.0–35.0) for patients receiving ≥100 Gy (n=12), compared to 6.0 months (95% CI 1.0–11.0) for those receiving <100 Gy (N=9), surpassing historical bevacizumab monotherapy outcomes (mOS ~7.4–9.2 months)...SPECT/CT imaging confirms high tumor-specific radiation retention, with minimal systemic exposure. These results support Reyobiq's promising safety and efficacy profile, warranting further investigation as a novel therapeutic for recurrent GBM, addressing a critical unmet medical need."

Clinical • P1/2 data • P2 data • Brain Cancer • CNS Disorders • Cognitive Disorders • Developmental Disorders • Glioblastoma • Solid Tumor

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 (SNO 2025) - "Rhenium (186Re) Obisbemeda (186RNL; Reyobiq), a novel radiotherapeutic consisting of 186Re encapsulated in nanoliposomes, is under investigation for convection enhanced delivery in recurrent glioblastoma (GBM) in the Phase 1/2 ReSPECT-GBM trial (IND 116117)...Preliminary efficacy data from Phase 1 cohorts 1 to 6 (N=21) showed a median overall survival (mOS) of 17.0 months (95% CI 8.0–35.0) for patients receiving ≥100 Gy (n=12), compared to 6.0 months (95% CI 1.0–11.0) for those receiving <100 Gy (N=9), surpassing historical bevacizumab monotherapy outcomes (mOS ~7.4–9.2 months)...SPECT/CT imaging confirms high tumor-specific radiation retention, with minimal systemic exposure. These results support Reyobiq's promising safety and efficacy profile, warranting further investigation as a novel therapeutic for recurrent GBM, addressing a critical unmet medical need."

Clinical • P1/2 data • P2 data • Brain Cancer • CNS Disorders • Cognitive Disorders • Developmental Disorders • Glioblastoma • Solid Tumor

Assessment of rhenium-186 obisbemeda (186RNL) therapy for recurrent glioblastoma (rGBM) using MRI and SPECT imaging biomarkers (SNO 2025) - "These findings support the effectiveness of combining MRI and SPECT imaging to access 186RNL delivery and its therapeutic outcomes in rGBM. Imaging biomarkers such as TCR, MTT and TTP may serve as useful predictors of treatment response and clinical outcomes and could guide future patient-specific treatment planning."

Biomarker • Brain Cancer • Glioblastoma • Solid Tumor

Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data (SNO 2025) - P1 | "Cohort 1 data, including safety and preliminary efficacy, will be presented. This study builds on single-dose findings, aiming to optimize dosing regimens to improve outcomes for LM patients, addressing an unmet clinical need with a novel radiotherapeutic approach."

Clinical • P1 data • Hematological Disorders • Solid Tumor • Thrombocytopenia

Plus Therapeutics to Present ReSPECT Phase 1 Dose Escalation Study Results for Leptomeningeal Metastases at the 2025 San Antonio Breast Cancer Symposium (GlobeNewswire) - "Study findings to be featured in a poster spotlight presentation."

P1 data • Brain Cancer • CNS Tumor

Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data (WFNOS 2025) - P1 | "Cohort 1 data, including safety and preliminary efficacy, will be presented. This study builds on single-dose findings, aiming to optimize dosing regimens to improve outcomes for LM patients, addressing an unmet clinical need with a novel radiotherapeutic approach."

Clinical • P1 data • Hematological Disorders • Solid Tumor • Thrombocytopenia

Assessment of rhenium-186 obisbemeda (186RNL) therapy for recurrent glioblastoma (rGBM) using MRI and SPECT imaging biomarkers (WFNOS 2025) - "These findings support the effectiveness of combining MRI and SPECT imaging to access 186RNL delivery and its therapeutic outcomes in rGBM. Imaging biomarkers such as TCR, MTT and TTP may serve as useful predictors of treatment response and clinical outcomes and could guide future patient-specific treatment planning."

Biomarker • Brain Cancer • Glioblastoma • Glioma • Solid Tumor

Plus Therapeutics Highlights ReSPECT-LM Clinical Trial Results at 40th SITC Annual Meeting, Melanoma Research Foundation Brain Metastases Summit 4.0 (The Manila Times)

P1 data • Brain Cancer • CNS Tumor

Q3 2025 FINANCIAL RESULTS (GlobeNewswire) - "Recognized $1.4 million in grant revenue in the third quarter of 2025 compared to $1.5 million in the same quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM."

Commercial • Brain Cancer • CNS Tumor

CA2024-LM-001: Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Plus Therapeutics

New P1 trial • Oncology • Solid Tumor

Plus Therapeutics Presents ReSPECT-LM Clinical Trial Results for REYOBIQ in Patients with Leptomeningeal Metastases (GlobeNewswire) - "Plus Therapeutics...announces the oral presentation of its ReSPECT-LM clinical trial results and a sponsored educational symposium, at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025....'At SNO/ASCO this year, our objective is to present the final clinical trial results and proposed clinical development path forward to clinical leaders in Neuro-oncology and further discuss this in our sponsored symposium'....Plus will also host an educational symposium with leading experts titled, 'Reimagining Your Approach to Leptomeningeal Metastases'....The session will focus on the latest advancements in understanding and managing LM, including a deep dive into REYOBIQ and CNSide and their potential roles in both prolonging life and improving the quality of life in patients with LM."

Clinical data • Brain Cancer • CNS Tumor

Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Plus Therapeutics

New P1 trial • Brain Cancer • Ependymoma • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor

Plus Therapeutics Announces Initial Patients Successfully Treated in ReSPECT-LM Dose Optimization Trial for REYOBIQ in Leptomeningeal Metastases (GlobeNewswire) - "Plus Therapeutics...has announced the successful treatment of initial patients in its ReSPECT-LM dose optimization trial for REYOBIQ (rhenium Re186 obisbemeda) targeting leptomeningeal metastases (LM). The trial follows promising Phase 1 results where 5 out of 7 patients achieved over 80% reduction in LM tumor cells and survived at least one year post-treatment....The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial."

FDA event • P1 data • Trial status • CNS Tumor

Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQ for the Treatment of Childhood Brain Cancer (GlobeNewswire) - "Plus Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQ (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense."

Financing • IND • Ependymoma • High Grade Glioma

Plus Therapeutics Reports First Quarter Financial Results and Recent Business Highlights (GlobeNewswire) - "Q1 2025 FINANCIAL RESULTS:...The Company recognized $1.1 million in grant revenue in the first quarter of 2025 compared to $1.7 million in in the first quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM."

Commercial • CNS Tumor