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Highlights
- ReSPECT-LM Phase 1 trial shows favorable safety profile and clinical benefit across multiple measures.
- REYOBIQ demonstrated tumor cell reduction with no dose-limiting toxicities up to recommended Phase 2 dose.
- Data to be presented at SITC Annual Meeting and MRF Brain Metastases Summit 4.0 on Nov. 9, 2025.
Plus Therapeutics, Inc. (NASDAQ:PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, will present clinical trial data for REYOBIQ and ReSPECT-LM at the 40th Society for Immunotherapy of Cancer Annual Meeting and Melanoma Research Foundation Brain Metastases Summit 4.0 on November 9, 2025, in Alexandria, VA. Dr. Andrew Brenner, Professor of Medicine at The University of Texas Health Science Center at San Antonio, will highlight the results in the leptomeningeal metastases (LM) session.
Phase 1 Trial Outcomes
The ReSPECT-LM Phase 1 single-dose escalation trial, previously reported at the 2025 SNO/ASCO CNS Metastases conference, demonstrated:
- Clinical benefit rate exceeding 75% across three key outcome measures.
- Evidence of tumor cell death through RNA sequencing and circulating tumor cell reduction.
- No dose-limiting toxicities, with a favorable safety profile at doses up to the recommended Phase 2 dose of 44.1 mCi.
Dr. Brenner commented:
"Given the growing incidence and unmet need, with no approved therapies for LM, we are encouraged by the continued interest in the ReSPECT-LM data, which demonstrated excellent tolerance of REYOBIQ at much higher doses than current standard, which we believe supports its broad therapeutic range. REYOBIQ has been granted FDA Fast Track and Orphan Drug Designation, with enrollment in the ReSPECT-LM Dose Optimization Trial ongoing."
About Leptomeningeal Metastases
LM is a rare but severe complication of advanced cancer affecting the cerebrospinal fluid–lined structures of the CNS. It occurs in roughly 5% of patients with metastatic cancer, most commonly from breast cancer, lung cancer, and melanoma. Median survival ranges from 2–6 months, and treatment options are limited.
REYOBIQ Overview
REYOBIQ (rhenium Re186 obisbemeda) is a radiotherapeutic designed to deliver high-dose, targeted radiation to CNS tumors. Its formulation aims to reduce off-target effects while enabling imaging via gamma energy, supporting treatment of recurrent glioblastoma, LM, and pediatric brain cancer. ReSPECT-LM is funded by a 17.6M USD grant from the Cancer Prevention & Research Institute of Texas, and other studies, including ReSPECT-GBM and ReSPECT-PBC, are supported by NCI and the U.S. Department of Defense, respectively.
CNSide Diagnostics and Plus Therapeutics
CNSide Diagnostics, a wholly owned subsidiary, develops laboratory assays such as CNSide® for detecting CNS metastases. Plus Therapeutics combines image-guided beta radiation with targeted delivery to advance therapies for difficult-to-treat CNS cancers, leveraging strategic partnerships for development, manufacturing, and potential commercialization.
