CNSide™ assay is the gold standard diagnostic cerebrospinal fluid (CSF) assay for patients with suspected central nervous system (CNS) cancers
As part of the agreement, Plus obtains a nonexclusive license and option for exclusivity for patients receiving CNS radiotherapy
AUSTIN, Texas, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it has expanded its supply agreement with Biocept by acquiring an option to exclusively license Biocept's CNSide, a CSF-based tumor cell capture and enumeration platform, for patients receiving CNS radiotherapy. The option ensures that Plus Therapeutics has ongoing expanded access to the diagnostic CSF assay for patients with CNS cancers and can further develop and improve the assay specifically for patients with CNS cancers receiving radiotherapy.
“Thus far, in our ReSPECT-LM trial, we have had a very positive experience with the CNSide assay and think it has significant diagnostic potential,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The announced agreement is an important building block to ensure Plus Therapeutics remains at the forefront of CNS cancer therapy.”
Under the terms of the agreement, CNSide developer, Biocept, has granted Plus Therapeutics a non-exclusive license to its CNSide cell enumeration assay for Plus’ investigational therapy for leptomeningeal metastases (LM), rhenium (186Re) obisbemeda, and an option for an exclusive license to the assay. In exchange, Plus Therapeutics will provide $150,000 of its common stock to Biocept. Prior to January 1, 2025, Plus Therapeutics will have the option for exclusivity for the field of radiotherapy in exchange for a $1.0 million payment, to be exercised at Plus Therapeutics’ discretion.
“Use of the CNSide assay has the potential to substantially improve the diagnostic paradigm for patients with solid tumor leptomeningeal disease and could provide valuable information for these patients who have limited treatment options but where a targeted therapy may be beneficial,” said Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University’s Feinberg School of Medicine. “Paired with novel investigational therapeutics such as Plus Therapeutics’ rhenium (186Re) obisbemeda, the overall clinical management of these challenging patients could be transformed.”
CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer and melanoma which are leading causes of LM. CNSide provides a sensitive and specific quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or imaging monitoring.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.
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 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly 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 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 live 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 $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
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 robust 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/.
About Biocept, Inc.
Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers. Biocept has developed and is commercializing the CNSide™ cerebrospinal fluid assay that detects cancer cells that have metastasized to the central nervous system. Biocept’s patented technology captures and quantitatively analyzes CSF tumor cells for tumor-associated molecular markers. For more information, visit www.biocept.com.
1The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.
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