NEW YORK – Biocept said Friday that it has signed a non-exclusive licensing agreement for its CNSide assay with Plus Therapeutics, expanding the two firms' existing 2022 laboratory services agreement.
Plus is using CNSide in a clinical trial of its targeted radiotherapeutic rhenium 186 obisbemeda in patients with carcinomas aor melanomas with suspected leptomeningeal metastases (LM), a spread of cancer to the membranes that surround the brain and spinal cord. CNSide is a cerebrospinal fluid (CSF)-based liquid biopsy test, based on a cell capture and enumeration platform coupled with assays to identify actionable molecular treatment targets.
The companies' new agreement allows Plus to perform CNSide testing during its clinical trials and potentially commercially, subject to regulatory approval. Plus recently announced completion of Phase 1/Part A of its ReSPECT-LM dose-escalation clinical trial in patients with LM and has received US Food and Drug Administration approval to move to Phase I/Part B.
Under the agreement, San Diego-based Biocept is providing expertise, including consulting on equipment and materials sourcing, as well as the necessary technology and training to perform the assay. Plus, headquartered in Austin, Texas, will pay Biocept an upfront fee of $150,000 in stock, plus $6,000 for each 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 performed. The license agreement also gives Plus the option to negotiate for third-party exclusivity with a $1,000,000 payment to Biocept.
"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," Biocept President and CEO Antonino Morales said in a statement.