अमूर्त

Detection and evaluation of ELISA analysis for the circulating cancers sera antigens by monoclonal antibody UNIVmAB and pembrolizumAB.

D Manjunath, Vishal V Immanuel, Naveen Puttaswamy, Sashidhara AV, Anil Thomas, Shib D Banerjee

Detection and diagnosis of multiple human blood cancers sera remain a challenge, Recently we have reported a research note on a common sera biomarker for various cancers sera. However, a highly sensitive assay is required for the early and late cancers detections. We have developed an ELISA for an antigen detected by a specific monoclonal antibody, named UNIVmAb and with pembrolizumAb for comparison in all human cancers of different grades.
This first method is based on the UNIVmAb antibody reaction, which is highly accurate and reproducible for serum antigen present in sera of different grades of cancer patients compared to the normal subjects. In this report, human sera from >90 cancer patients with known TNM classification along with sera from 72 normal healthy individuals were analyzed by UNIVmAb/PembrolizumAb for blood cancers sera antigen. This ELISA using UNIVmAb has identified the antigen from human sera as a complex hyaluronan binding protein composed mainly of multiple unknown proteins, including human serum albumin. The limit of detection for the antigen ELISA with UNIVmAb is 4ng to 12ng, giing>80%-85% higher values than the healthy donors. However, anti PD 1(PembrolizumAb) is 30%-40% higher the healthy donors in most of the cancer patients. We validate enzyme-linked immunosorbent assay (ELISA) for quantification of human sera specific antigen in various cancers sera samples and to compare the protein levels in normal subjects to cancer patients. Such results indicate that this ELISA value may be useful as a diagnostic marker for various cancer patients with UNIVmAb than with anti PD 1 antibody. Even though the use of immune checkpoint inhibitors have provided a breakthrough in immunotherapy for malignant tumors, PembrolizumAb or Nivolumab has significantly improved the survival of patients with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and classic Hodgkin lymphoma . Biomarkers that predict the treatment response to immune checkpoint inhibitors have also been explored. PD-1 expression in tumor cells was associated with objective response rates (ORRs) to nivolumab in some studies.
Clinically approved immune checkpoint inhibitors such as anti-PD1 or anti-CTLA 4 demonstrate clinical efficacy in only a small proportion of cancer patients. The majority of cancer patients either show primary resistance or develop acquired resistance. The present data with ELISA indicate that the UNIVmAb is more applicable in detecting all primary or progressive cancers in circulating human sera and potentially can be used as a common cancer biomarker.