Biocept, Inc. (Nasdaq: BIOC), a prominent provider of molecular diagnostic assays, products, and services, has announced the signing of a non-exclusive licensing agreement for CNSide™ with Plus Therapeutics, Inc. (Nasdaq: PSTV) (Plus). This agreement expands upon the comprehensive laboratory services agreement between the two companies that was initially revealed in June 2022. Plus is utilizing CNSide in a clinical trial involving their targeted radiotherapeutic treatment for patients with carcinomas and melanomas suspected of having leptomeningeal metastases (LM), a condition characterized by cancer in the membranes surrounding the brain and spinal cord. CNSide is a proprietary platform developed by Biocept for capturing and enumerating tumor cells in cerebrospinal fluid (CSF), used to detect, quantify, and monitor tumor status in LM.

Under this new agreement, Plus gains the capability to conduct CNSide testing during its clinical trials and for commercial purposes, subject to regulatory approval. Biocept will provide expertise, including consultation on equipment and material procurement, as well as the necessary technology and training for CNSide testing. Plus will compensate Biocept with an upfront fee of $150,000 in stock, in addition to $6,000 for each CSF tumor cell enumeration analysis performed in Biocept's CLIA-certified and CAP-accredited laboratory before the technology transfer is completed. Once the technology transfer is finalized, 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 grants Plus the option to negotiate for third-party exclusivity, contingent upon a $1,000,000 payment to Biocept.

Antonino Morales, President and CEO of Biocept, expressed satisfaction in Plus's continued recognition of the value of CNSide in managing leptomeningeal metastases. He highlighted their shared commitment to enhancing the lives of patients with central nervous system (CNS) cancer. Morales also emphasized the agreement's importance in validating the clinical utility of CNSide and its role in diagnosing and monitoring LM patients. Furthermore, it sets the stage for potential agreements with other companies developing treatments for CNS cancer and provides Biocept with non-dilutive funding to advance the establishment of CNSide as the standard of care, following the guidelines of the National Comprehensive Cancer Network® (NCCN®).

Morales added, "Plus will reimburse Biocept for CNSide testing performed before the completion of the technology transfer at $6,000 per enumeration. This amount more than covers our costs and potentially sets the stage for reimbursement at a similar level in future arrangements."

Plus is utilizing CNSide in its ReSPECT-LM Phase 1/2a dose-escalation clinical trial involving Rhenium 186 Obisbemeda for the treatment of LM patients. Plus recently announced the completion of Phase 1/Part A of the trial and presented promising preliminary safety and efficacy results. Plus has received approval from the U.S. Food and Drug Administration (FDA) to proceed to Phase 1/Part B of the ReSPECT-LM clinical trial.

Marc H. Hedrick, M.D., President and CEO of Plus Therapeutics, emphasized the significance of the CNSide test as an emerging gold standard for the definitive diagnosis and follow-up of LM patients. He noted that CNSide technology may, in the near future, complement or replace existing diagnostic methods for cerebrospinal fluid malignancies. CNSide is seen as a valuable addition to their novel radiotherapeutic technology, Rhenium 186 Obisbemeda, which is currently undergoing clinical development for leptomeningeal metastases in their actively enrolling ReSPECT-LM trial.

 

Source: businesswire.com

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