Natural killer (NK) cells first earned their title as “killers” nearly 40 years ago when researchers observed the rapid immune response of these lymphocytes as they destroyed host cells infected with a virus or tumor cells. It seemed that NK cells could attach spontaneously without prior activation. Over time, researchers have learned more about the molecular mechanisms that regulate their activation and function.
Today, the NK cell assay is used to support specialty immunotoxicology studies for safety assessment. At Covance, we work with clients that often ask us about performing a NK cell functional analysis and the role of standard immunophenotyping to enumerate cells. This article addresses these questions by providing a brief background on the innate immunity of NK cell biology and comparing assay methods. Continue reading
The field of cancer immunology or immuno-oncology (I/O) dates back to the 1890’s with efforts by William Coley to treat malignancies by infection with certain bacterial strains.1 Fast forward 120 years, and we have observed the clinical success of multiple checkpoint inhibitor antibodies against cancer specific T cell negative regulatory pathways in multiple cancer types.2 Because of these clinical successes with antibodies targeting CTLA-4, PD-1, and PD-L1 (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab), vast resources in biotech and large pharma are being directed toward preclinical I/O research in an effort to develop novel immunotherapies.
In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading
No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies.
RA patients in the United States
While the test results are clearly valuable to the requesting physician to inform diagnostic decisions, sponsors can also leverage this information to support patient recruitment in an increasingly competitive space. We recently evaluated how de-identified patient data from these common tests run by LabCorp can support sponsors’ clinical trials in rheumatoid arthritis. Continue reading
Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today’s regulatory environment. Continue reading
Providing integrated services to the global biotech and pharma industry
Covance and Arcinova recently expanded a strategic relationship following the signing of a sales services agreement at the end of 2016. Under the terms of the agreement, Covance is offering Arcinova services alongside its own extensive range of drug development capabilities.
Arcinova is a contract research and development organization based in Alnwick, UK. The Company provides small molecule drug substance, product and analytical support from preclinical through to Phase II. Since its inception in February 2016, Arcinova has built on the legacy customer base developed when it was a Covance site, and is now serving biotechnology and pharmaceutical companies on four continents. Continue reading
Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the mechanisms of immune response to various antigens, thereby aiding them in the development of novel approaches to treat immune-system-related diseases and better design vaccines to combat infectious agents and cancer.
Currently, one of the most sensitive techniques available for the detection, measurement, and functional analysis of immune cells is the enzyme-linked immunospot (ELISPOT) assay. Covance uses the ELISPOT technique in applications such as evaluation of vaccine efficacy and immunogenicity of biological products.