35 research outputs found
A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"
The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document
Emerging concepts in biomarker discovery; The US-Japan workshop on immunological molecular markers in oncology
Supported by the Office of International Affairs, National Cancer Institute (NCI), the "US-Japan Workshop on Immunological Biomarkers in Oncology" was held in March 2009. The workshop was related to a task force launched by the International Society for the Biological Therapy of Cancer (iSBTc) and the United States Food and Drug Administration (FDA) to identify strategies for biomarker discovery and validation in the field of biotherapy. The effort will culminate on October 28th 2009 in the "iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer", which will be held in Washington DC in association with the Annual Meeting. The purposes of the US-Japan workshop were a) to discuss novel approaches to enhance the discovery of predictive and/or prognostic markers in cancer immunotherapy; b) to define the state of the science in biomarker discovery and validation. The participation of Japanese and US scientists provided the opportunity to identify shared or discordant themes across the distinct immune genetic background and the diverse prevalence of disease between the two Nations
Real-time PCR analysis of genes encoding tumor antigens in esophageal tumors and a cancer vaccine
Tumor antigens are the primary target of therapeutic
cancer vaccines. We set out to define and compare the expression
pattern of tumor antigen genes in esophagus carcinoma biopsies and
in an allogeneic tumor lysate-based cancer vaccine, MelCancerVac®.
Cells used for vaccine production were treated with the DNA methyltransferase
inhibitor 5-aza-2'-deoxycytidine (5-aza-CdR) to determine whether
this treatment could improve the profile of tumor antigen genes
expressed in these cells. In addition, the presence of MAGE-A tumor
antigen protein was evaluated in the purified tumor cell lysate
used in the production of the vaccine. Quantitative PCR was used
to assay 74 tumor antigen genes in patients with squamous cell carcinoma
of the esophagus. 81% (13/16) of tumors expressed more
than five cancer/testis (CT) antigens. A total of 96 genes
were assayed in the tumor cell clone (DDM1.7) used to make tumor
cell lysate for vaccine preparation. Gene expression in DDM1.7 cells
was compared with three normal tissues; 16 tumor antigen genes were induced
more than ten-fold relative to normal tissues. Treatment with 5-aza-CdR
induced expression of an additional 15 tumor antigens to a total
of 31. MAGE-A protein was detected in cell lysate by Western blot
at an estimated concentration of 0.2 µg/ml or
0.01% of the total protein