SEATTLE, Sept. 13, 2013 /PRNewswire/ -- Adaptive Biotechnologies announced today that it received a $2.53 million Phase II Small Business Innovation Research award from the National Heart, Lung, and Blood Institute, a division of the NIH, to commercialize a test to measure the ability of a cancer patient's adaptive immune system to fight infection after a cord blood transplant. The phase II study follows promising phase I results presented at ASCO 2012 showing a statistical correlation between low diversity of infection-fighting immune cells (T-cells) and high likelihood of death from complications, including infection, during the first year after transplant.
It is widely recognized that the ability for a cord blood transplant recipient to reconstitute a healthy immune system is critical for overall survival. However, the existing standard of care only measures absolute T-cell counts, which did not show a correlation to the risk of infection in the phase I study.
"We are delighted to be the recipients of this important grant which aims to provide clinicians with a test to reliably identify patients who are not reconstituting a healthy, diverse immune system after transplant," said Chad Robins, CEO and Founder of Adaptive Biotechnologies.
"Identifying patients at risk for infection early after transplant is something that we strive to do in the clinic, but the current standard of using total T-cell counts seems to be suboptimal," said Dr. Colleen Delany, Cord Blood Transplant Program Director at The Fred Hutchinson Cancer Center. "We are pleased to be leading this effort to identify a better way to measure immunity and ultimately increase overall survival for our transplant patients."
Adaptive's Next-Generation Sequencing platform, immunoSEQ, will be used in the phase II study to measure T-cell and B-cell diversity. The study will be conducted prospectively over a three-year period on approximately 400 cord blood transplant recipients from five of the top transplant centers in the United States. Patients' blood will be drawn at several time points after transplant and shipped to Adaptive's CLIA-certified centralized laboratory in Seattle. The company's immunosequencing platform and accompanying bioinformatics tools will be used to calculate a precise measure of diversity for each patient at each time point. While cord blood transplant serves as an ideal model to confirm the importance of immune reconstitution because of the higher incidence of infectious morbidity and mortality compared to other tissue sources used for stem cell transplants, the results should apply to all stem cell transplantation procedures.
This test of immunocompetence will add to Adaptive's portfolio of products that use immunosequencing for prognosis, diagnosis, and monitoring of cancer patients. The company's first clinical application, clonoSEQ,is for monitoring Minimal Residual Disease ("MRD") in blood-based cancers.
About Adaptive Biotechnologies
Adaptive Biotechnologies Corporation ("Adaptive" or the "Company") is a development stage biotechnology company that utilizes its proprietary immune profiling technology to discover, develop, and commercialize oncology diagnostics. The Company leverages advances in next generation sequencing ("NGS") to profile T-Cell and B-Cell Receptors ("TCRs" and "BCRs"). This breakthrough enables in-depth characterization of the immune system, which is the primary defense against cancer. By incorporating immunosequencing into clinical care, Adaptive can enhance the diagnosis, prognosis, and monitoring of cancer patients. The Company's first clinical application, clonoSEQ, is for monitoring Minimal Residual Disease ("MRD") in blood-based cancers. The Company recently launched clonoSEQTM as a CLIA certified Laboratory Developed Test ("LDT") in the second quarter of 2013. Improving the ability to accurately detect and track residual disease at a molecular level affords clinicians the potential to detect relapse earlier and improve patient care. Adaptive is currently validating additional oncology diagnostics to quantify the presence and clonality of Tumor Infiltrating Lymphocytes ("TIL") and to create a reliable measure of "immunocompetency" to predict or monitor response to cancer treatments that directly alter the host immune system. Adaptive incubates and validates potential clinical products by offering fee-for-service access to its proprietary immune profiling sequencing technology under the brand name immunoSEQ.
SOURCE Adaptive Biotechnologies Corporation