SOUTH SAN FRANCISCO, Calif. OCTOBER 20, 2014 – Sequenta, Inc., a biotechnology company developing clinical diagnostics based on immune cell receptor genes, today announced an equity investment by Celgene Corporation and other strategic investors. This financing, in addition to funding secured from several other strategic investors, will support incorporation of the ClonoSIGHT™ minimal residual disease (MRD) test into clinical trials of medicines in development for various hematological malignancies (blood cancers) and development of new clinical diagnostics based on Sequenta’s revolutionary LymphoSIGHT™ platform.
MRD refers to the small numbers of cancer cells that remain in a patient’s body during or after treatment that can be reliably detected only by using sensitive molecular technologies. Testing for MRD can help determine whether cancer treatment has been successful, provide important information about patient prognosis and help guide additional treatment decisions.
“The ability to measure depth and quality of responses using MRD assays will enable scientists to monitor the clinical impact of existing and novel emerging therapies in hematological and other cancers. Sequenta’s technology also has potential applications in the study of immune therapy approaches in solid tumors and immune inflammatory diseases,” said Rajesh Chopra, M.B.B.S., Ph.D., Corporate Vice President, Translational Development at Celgene Corporation. “This investment in Sequenta is reflective of our belief in Sequenta’s approach and part of our broader commitment to play a leading role in immunotherapy across a number of therapeutic concepts.”
“The ClonoSIGHT MRD test has been validated across multiple blood cancers, and is used as a clinical decision-making tool by physicians at major cancer centers throughout the United States,” said Tom Willis, CEO of Sequenta. “Celgene’s investment in Sequenta, along with the other strategic investors, will further support adoption of our powerful minimal residual disease detection and quantification technology as the emerging standard for response assessment and disease monitoring in clinical trials of medicines for blood cancers, as well as the development of new applications of our LymphoSIGHT platform.”
About the ClonoSIGHT™ Process
Sequenta’s ClonoSIGHT process enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as a clinical decision-making tool for patients with lymphoid cancers (blood cancers). Clinical validation studies have shown that this process, which utilizes Sequenta’s LymphoSIGHT™ platform, offers significant improvements in sensitivity and performance over other MRD detection methods.
MRD detection and quantification using the ClonoSIGHT process involves two steps that are easily integrated into patient care. In the first step, the ClonoSIGHT ID test, cancer cell DNA sequences are identified in a diagnostic sample. In the second step, the ClonoSIGHT MRD test, follow-up samples are screened for the previously identified sequences in order to detect residual disease. ClonoSIGHT test results are generated in seven days using Sequenta’s CLIA-certified, CAP-accredited laboratory. These results are provided to the ordering physician in a simple, actionable report that shows a patient’s MRD status and level, as well as MRD trends over time via a secure online portal. The ClonoSIGHT process has been validated in diffuse large B-cell lymphoma, multiple myeloma, acute lymphoblastic leukemia, chronic lymphocytic leukemia and mantle cell lymphoma. For more information, please visit clonosight.com.
About the LymphoSIGHT™ Platform
Sequenta’s LymphoSIGHT platform is a simple and scalable laboratory process that allows each of the several million B and T cells (lymphocytes) in a blood or tissue sample to be characterized and enumerated. Individual cells can be detected at levels as low as one cell per million white blood cells. The LymphoSIGHT platform combines proprietary multiplexed PCR assays for the universal amplification of rearranged immunoglobulin and T-cell receptor genes with powerful algorithms for the analysis of next-generation sequencing data.
Sequenta has commercialized the LymphoSIGHT platform for clinical use in minimal residual disease (MRD) detection in lymphoid cancers as the ClonoSIGHT™ process. The company is also investigating the use of the LymphoSIGHT platform in a diverse set of immune-mediated diseases and as a method for evaluating the efficacy of therapies based on immune system modulation.
Sequenta is a biotechnology company dedicated to improving patient care in diseases mediated by immune cells through the discovery and development of novel clinical diagnostics. The company, located in South San Francisco, was founded in 2008 and has received venture funding from Mohr Davidow Ventures, Index Ventures and Foresite Capital. For more information, please visit sequenta.com.