On September 8, 2023 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products, and services, reported the signing of a non-exclusive licensing agreement for CNSide with Plus Therapeutics, Inc. (Nasdaq: PSTV) (Plus), which expands the comprehensive laboratory services agreement between the two companies that was announced in June 2022 (Press release, Biocept, SEP 8, 2023, View Source [SID1234635038]). Plus is using CNSide in a clinical trial with their targeted radiotherapeutic to treat patients with carcinomas and/or melanomas with suspected leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord. CNSide is Biocept’s proprietary cerebrospinal fluid (CSF)-based tumor cell capture and enumeration platform used in detecting, quantifying, and monitoring tumor status in LM.
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This new agreement allows for Plus to perform CNSide testing during its clinical trials and commercially, subject to regulatory approval. Biocept will provide expertise, including consulting on equipment and materials sourcing, as well as providing the necessary technology and training to perform CNSide. Plus will pay Biocept an upfront fee of $150,000 in stock, plus $6,000 per CSF tumor cell enumeration analysis performed in Biocept’s CLIA-certified and CAP-accredited laboratory prior to the completion of the technology transfer. Once the technology transfer is complete, Plus will pay Biocept $300,000 plus fees on a sliding scale starting at $2,800 for each CNSide test they perform. The license agreement also gives Plus the option to negotiate for third-party exclusivity with a $1,000,000 payment to Biocept.
"We are gratified that Plus continues to recognize the value of CNSide in leptomeningeal metastases disease management. We share their commitment to improving the lives of patients suffering from cancer of the central nervous system (CNS)," said Antonino Morales, Biocept President and CEO. "We view this agreement as further validation of the clinical utility of CNSide and the important role it plays in diagnosing and monitoring patients with LM. It also sets the stage for future agreements with other companies developing treatments for cancer of the CNS and provides Biocept with non-dilutive funding to support our goal of establishing CNSide as standard of care under the National Comprehensive Cancer Network (NCCN) guidelines.
"Importantly, Plus will reimburse Biocept for CNSide testing performed prior to completion of the technology transfer at $6,000 per enumeration," he added. "This amount more than covers our costs and potentially sets the stage for reimbursement at a similar level in future arrangements."
Plus is using CNSide in its ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium 186 Obisbemeda for the treatment of patients with LM. Plus recently announced completion of Phase 1/Part A of the trial and presented favorable preliminary safety and efficacy results. Plus has received U.S. Food and Drug Administration (FDA) approval to move to Phase 1/Part B of the ReSPECT-LM clinical trial. For more information on Plus, please visit www.plustherapeutics.com.
"The CNSide test is the emerging gold standard for the definitive diagnosis and follow up of patients with LM," said Marc H. Hedrick, M.D., President and CEO of Plus Therapeutics. "The CNSide technology may, in the near future, supplement or replace existing diagnostic technology for cerebrospinal fluid malignancies. We view CNSide as an important complement to our novel radiotherapeutic technology, Rhenium 186 Obisbemeda, now in clinical development for leptomeningeal metastases in our actively enrolling ReSPECT-LM trial."
About CNSide
CNSide is a laboratory developed test (LDT) based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.