On December 12, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it has partnered with K2bio (Houston, Texas) to implement novel analysis for cerebrospinal fluid (CSF) tumor and molecular biomarkers for CNS cancers (Press release, Plus Therapeutics, DEC 12, 2023, View Source [SID1234638505]). Initial clinical specimen processing and testing will begin in Q1 2024 in the Company’s ongoing Phase 1 ReSPECT-LM trial of rhenium (186Re) obisbemeda in patients with leptomeningeal metastases (LM). This trial is currently receiving grant funding through The Cancer Prevention and Research Institute of Texas (CPRIT). The Company expects testing costs to be partially covered under this grant.
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"The initial diagnosis, therapeutic selection and monitoring of patients with CNS cancers such as leptomeningeal metastases are significant problems in everyday clinical practice," said Marc H. Hedrick, M.D., President & Chief Executive Officer of Plus Therapeutics. "To turn these very lethal CNS cancers into treatable diseases, we must ideally address both the diagnostic as well as the therapeutic needs of caregivers and patients. This partnership with K2bio is the next part of our overall strategy to address both needs in parallel."
K2bio is a hybrid contract research organization (CRO) enabling life science companies to develop the next generation of innovative therapies. K2bio is based in Houston and is part of the Texas Medical Center life sciences ecosystem specializing in all aspects of translational cancer diagnostic and therapeutic research and development.
"K2bio is a leader in enabling rapid diagnostic and therapeutic progress for innovative companies such as Plus," said Colby Suire, PhD, acting President and CEO of K2bio. "We have all the necessary capabilities and expertise to accelerate and support Plus’ mission to be a leader in the development of targeted radiotherapeutics and related diagnostics for CNS cancers."
Plus’ tumor cell and molecular biomarker analysis is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in early cohorts. In Phase 1/part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus data showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM, and the ReSPECT-LM Phase 1 program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).