Adaptive Biotechnologies | February 19, 2022
Adaptive Biotechnologies Corporation a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, presented data on T-cell receptor (TCR) sequences associated with Crohn’s disease (CD) during an oral presentation today at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO) being held virtually February 16-19. The study identified and characterized TCR sequences associated with CD utilizing Adaptive’s immunoSEQ® technology, providing fundamental insights into the body’s response to CD at the cellular level.
The immunoSEQ assay uses sequencing technology to decipher the complexity of the adaptive immune system. This multi-national study, which was also recently published in The Journal of Crohns and Colitis, utilized immunoSEQ technology to analyze TCRs from blood samples of 1,738 CD cases and 4,970 healthy donors. Intestinal tissue samples from a subset of 380 cases were also analyzed. Through this analysis, 1,121 CD-associated TCRs were identified in patients’ blood and verified in tissue. The identification of disease-specific TCRs is an important first step in identifying a signal and developing an algorithm to inform development of a diagnostic test for CD.
“The study identified Crohn’s-specific TCRs in both the blood and tissue of patients with Crohn’s disease, including a large subset that are ’public,’ or shared among patients. These findings suggest that blood-based testing for this often-debilitating disease could be used to diagnose and more effectively manage the disease through the identification of these disease specific T-cell receptors.”
Matthieu Allez, MD, PhD, Professor and Head, Department of Gastroenterology, Hospital Saint-Louis, Paris
T cells can have a significant impact on inflammation in CD, but until now, disease-associated TCRs have been largely unknown and underleveraged in diagnostics for the disease.1 These findings show that immunoSEQ can successfully identify TCRs for CD in a blood sample, which is reflective of the TCRs in intestinal tissue. The average length of time from onset of symptoms to diagnosis for a CD patient can be 1-2 years in the US but may be much longer in other countries, so the potential to open a new path to identify the disease earlier is significant.2,3 Furthermore, the amount of Crohn’s-related TCRs can provide insights into disease characteristics such as the phenotype and location of the disease, with possible clinical implications.
In addition to TCR findings, the analysis also studied the possible association between human leukocyte antigens (HLAs) alleles and CD-associated TCRs, which live on most cells in the body, by leveraging the novel immunoSEQ HLA Classifier. HLA alleles are genetic factors that have been found to contribute to a small portion of risk for CD. In this study, nearly 400 CD-associated TCRs were found to be associated with specific HLA alleles. These TCR associations highlight the importance of studying TCRs in the context of HLA type and potentially point to new risk factors and insights for CD such as the involvement of specific antigens that the immune system may be reacting to in people living with CD.
“We’re excited to see these results and their potential to advance the scientific community’s understanding of the immune response to Crohn’s disease. The use of immunoSEQ and characterization of TCRs in the blood have the potential to uncover new knowledge on the development and progression of the disease, with the potential to eventually improve diagnostic options and disease management for people living with Crohn’s,” said Harlan Robins, PhD, Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies. “We look forward to continuing our research and advancing the development of our T-Detect test to include an application in the diagnosis of Crohn’s disease.”
CD is a subtype of inflammatory bowel disease, a group of diseases impacting about 6.8 million adults globally.4 Early treatment with effective medications can prevent disease progression towards complications, surgery and disability. However, CD is difficult to diagnose and treat, with more than half of patients initially misdiagnosed. No single blood test currently exists for diagnosis of CD. Instead, patients often undergo a series of tests – often invasive – in order to reach a conclusive diagnosis.
Based on the results of this study, Adaptive is further investigating specific TCR signatures that are associated with CD related behavior and disease activity to further the development of T-Detect in this indication. Additional research will also focus on signal optimization and clinical validation to explore commercial utility.
About the immunoSEQ® Assay
Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and/or B-cell receptors from a single sample in exquisite detail. The immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures.
About T Detect™
T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is not FDA-cleared or approved, it has received an EUA from the FDA and is available for prescription use only.
About Adaptive Biotechnologies
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in our Immune Medicine and Minimal Residual Disease (MRD) businesses. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases.
CELL AND GENE THERAPY
EXUMA Biotech Corp. | December 22, 2021
EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies and delivery solutions for liquid and solid tumors, announced the completion of a $41 million Series B2 financing. The Series B2 brings the total capital raised since its inception to approximately $130 million.
Proceeds will be used to support further development of EXUMA's autologous subcutaneous rPOC CAR-TaNK platform for hematologic and solid tumors and continued clinical investigation of its Tumor Metabolism Regulated CAR technology targeting solid tumors. New investors in the Series B2 financing included Americo Life, Inc., in addition to existing investors.
"We are pleased to expand our investor base with support from this strategic group of investors who recognize the potential of our technologies to translate into life-changing therapies for cancer patients,"
Gregory Frost, Ph.D., EXUMA Biotech Chairman and Chief Executive Offer
"Dr. Holmes is a renowned cancer specialist who will make an outstanding addition to our board of directors. He has dedicated his life to researching advanced cellular and immunotherapy treatments for hematologic malignancies and to the education of the oncology community about these new modalities," said Frost.
Houston Holmes, M.D., received a BS in medical microbiology from Stanford University School of Medicine, an MD from the University of Texas Southwestern Medical School, and an MBA from the University of Texas at Dallas. He completed an internship and residency in internal medicine at Baylor University Medical Center, and fellowship in medical oncology/hematology at the National Cancer Institute/National Heart, Lung, and Blood Institute. Dr. Holmes has been in practice for over 20 years.
"It's an exciting time for cell and gene therapies. I'm thrilled to be a part of EXUMA and to join the company in its mission to advance innovative therapies towards the clinic and for cancer patients in urgent need of new treatments," said Houston Holmes, M.D.
About EXUMA Biotech
EXUMA Biotech is a clinical-stage biotechnology company pioneering the discovery and development of novel cellular therapies and gene delivery solutions for patients with cancer. The company leverages its global R&D footprint to discover, manufacture and develop gene delivery platforms and gene programs that may overcome the safety, efficacy, and scalability challenges of cellular therapies in solid tumor and hematologic malignancies. The company is headquartered in West Palm Beach.
Bioclean Innovations | October 19, 2020
Bioclean Innovations Inc, a Biotech startup focused on innovative antimicrobial solutions to combat disease outbreaks has partnered with rep-L® Antimicrobials, to launch a powerful but non-toxic bio-based antimicrobial product line. Our rep-L-based disinfectants are designed to create a new methodology for addressing the infection control challenges facing the education and long-term health care sectors today. The SARS-CoV-2 virus responsible for the COVID-19 pandemic is one of an increasing number of pathogens and antibiotic-resistant infections society is facing. Schools, universities, and care homes rely on a frequent cleaning and disinfection process which now requires more cleaning and disinfectant products and more labor while still leaving the risks of microbial transmission from contamination occurring on the surface in between disinfection cycles. Bioclean has developed a range of products, including continuously-active disinfectant, hand sanitizer, and disinfectant wipes that can kill and protect against viruses, bacteria, and fungi for thirty (30) days and longer, eliminating the need for frequent disinfection and providing effective, long-lasting protection on high touch surfaces and hands.