COMPANY:

Biocept

"Company acquired assets for the synergistic leptomeningeal metastases (LM) diagnostic platform, 'CNSide' and discussed potential partnering opportunities....Plus presented topline clinical trial data from the FORESEE trial which met its primary endpoint of clinical utility for the CNSide test in 40 patients with LM due to either breast or non-small cell lung cancer; a presentation of the full analysis is planned for the August 8-10 SNO/ASCO Meeting in Denver, CO."

"Biocept...announces the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123). This trial is evaluating the performance of Biocept’s proprietary CNSide assay in monitoring the response to therapy of LM, a cancer in the membranes that surround the brain and spinal cord, and assessing its impact on treatment decisions made by physicians."

"Biocept, Inc...announces the signing of a non-exclusive licensing agreement for CNSide™ with Plus Therapeutics, Inc...which expands the comprehensive laboratory services agreement between the two companies that was announced in June 2022....This new agreement allows for Plus to perform CNSide testing during its clinical trials and commercially, subject to regulatory approval....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."

"Biocept...announces that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12."

"Biocept...announces a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting underway in Chicago showing the ability of CNSide™ to detect rates of leptomeningeal metastases (LM) compared with standard CSF cytology from lumbar puncture. The poster, titled 'Evaluating the diagnostic performance of leptomeningeal diagnosis with CNSide compared to standard cytology,' was presented by Dr. Haley Appel at the Miami Cancer Institute, Baptist Health South Florida, on Saturday, June 3. The abstract of the poster is available here, including a link to the full poster which is accessible to ASCO registrants."

"Biocept...announces enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay CNSide (NCT05414123). This first patient was seen at the UT Southwestern Medical Center, one of the largest and most respected hospitals in the nation."

"Biocept...announces a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer...Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions."

"Biocept, Inc...announces the expanded commercial availability of CNSide for patients with metastatic melanoma. Previously validated for lung, breast, and all other carcinomas, Biocept’s CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS)...The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics."

"Biocept, Inc...announces an hour-long webinar to be held October 14 at 1 p.m. Eastern time featuring case studies presented by leading neuro-oncologists who have used the company’s CNSide assay in the management of patients with confirmed or suspected central nervous system metastasis."

"Plus Therapeutics, Inc...and Biocept, Inc...announce a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord."

"Biocept, Inc...highlighted the ability of its CNSide™ cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting. The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego."

"Biocept, Inc...presented a study demonstrating the ability of its CNSide™ assay to identify HER2 and other actionable tumor alterations in the cerebrospinal fluid of patients with breast cancer and leptomeningeal disease (LMD). The poster was chosen for a Spotlight Presentation at the San Antonio Breast Cancer Symposium on Dec. 8, 2021."

"Physicians in the United States can now order the liquid biopsy-based Target Selector™ NGS Lung Panel test directly from Quest Diagnostics...Developed by Biocept, Inc...the lab-developed liquid biopsy test aids genomic profiling in patients with advanced non-small cell lung cancer (NSCLC), helping physicians identify potential targeted therapies and monitor the effectiveness of treatment...The Target Selector NGS Lung Panel contributes to better patient outcomes by providing physicians with direction on therapeutic options for those battling NSCLC."

"Biocept...announced the presentation of a multi-institutional case series showing that its CNSide™ cerebrospinal fluid assay helps physicians monitor treatment response and detects actionable mutations in patients with metastatic breast cancer and leptomeningeal disease (LMD). The poster will be presented virtually at the Society for Neuro-Oncology Annual Meeting...At diagnosis, CNSide detected cancer cells in three of three patients, compared with two of three patients for cytology. (The fourth patient was diagnosed before CNSide was available.) CNSide detected CSF tumor cells in all eleven measurements taken, compared to six of eleven using cytology. Throughout treatment, CNSide showed a decrease in CSF tumor cells in all four patients, ranging from 99.7% to 100%, corresponding with an improved clinical response."

"Biocept, Inc...today announced the publication of a study showing that the addition of Switch-Blocker™ technology to common PCR-based liquid biopsy assays significantly increased sensitivity in detecting rare cancer mutations...Results showed that the addition of Switch-Blockers increased the sensitivity of allele-specific primer assays by more than 200 times, from about 1% minor allele frequency (MAF) to better than 0.01%. The sensitivity of multiplex competitive allele-specific TaqMan assays, commonly used with PCR amplification, were increased greater than 1,000 times, from about 10% MAF to 0.01% or better. The ability to significantly increase the sensitivity of conventional mutation assays using Switch-Blocker technology is critical for helping to find rare genetic events in a wide range of applications, including solid tumor cancers, where a majority of biomarkers in blood occur at less than 1% MAF."