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SITC

May 30, 2013

SITC Launches New, Online, Open Access Journal!


SITC is pleased to announce the launch of our new official Society journal, the Journal for ImmunoTherapy of Cancer (JITC). For more than a decade, SITC has led discussions and worked with key stakeholders in the field on creating this targeted publication dedicated to advancing the science of tumor immunology and cancer immunotherapy. Available to anyone anywhere, JITC has developed through the evolution of the field, the growth of the Society, and finally with the crystallization of SITC's 2012-2015 Strategic Plan.

This open-access, peer-reviewed journal encompasses all aspects of tumor immunology and cancer immunotherapy, from basic research through to clinical application. Today, more than ever before, the tremendous excitement in the field and the increased momentum brought about by the latest approvals of immunotherapy-based treatments in various cancer types has shown the clear need for the Journal for ImmunoTherapy of Cancer, an outlet devoted to and created by today's leaders in the field.

SITC welcomes you to read and explore our first issue here.

Highlighted in the inaugural issue:

FDA Review in Journal for ImmunoTherapy of Cancer Offers New Insights into Cancer Immunotherapy Product Development & Clinical Evaluation

A picture of what the FDA is looking for in cancer immunotherapy product development appears in an extensive new review article published in the inaugural issue of the Journal for ImmunoTherapy of Cancer. Providing a US regulatory perspective on pre-clinical to first in man studies, the review is described by Nora Disis, Professor of Medicine at the University of Washington/Fred Hutchinson Cancer Center, as a “must-read for anyone interested in immunooncology.” The review was written by members of the FDA’s Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), and Center for Drug Evaluation and Research (CDER).

As mechanisms of tumor immune escape have become better defined, approaches that combine two or more modalities to overcome immune resistance are increasingly being proposed and the FDA provides a plan for such approaches. The FDA recommends that researchers characterize each product individually and provide a strong scientific rationale for the combination. Further, even if the combination regimen uses a standard cytoreductive agent with immunologic effects, dose and timing of administration need to be presented.

“Importantly, the flexible parameters for development and evaluation presented in the document reflect the broader experience now in place and deeper understanding of how immune therapies might be applied in the new generation of trials in development,” said Lisa Butterfield, Associate Professor of Medicine, Surgery and Immunology at the University of Pittsburgh Cancer Institute.

The complexity of cancer immunotherapy products has made issues such as the definition of product potency, purity, and toxicology evaluation difficult. This review and series of recommendations from the FDA, in addition to the cited FDA guidances, provides considerations for product development that will be valuable for cell based and vaccine therapies, along with state of the art data needed for manufacturing, pre-clinical studies, and clinical trial designs of cancer immunotherapies. The review is particularly timely, given the rapid series of important recent advances and refinements of therapeutic approaches, and the significantly positive clinical outcomes achieved.

The document also addresses the issues of only testing immunotherapeutic interventions in advanced and metastatic disease patients, as well as of early tumor progression while in a study. It is now understood that both early and late stage patients can be included in immunotherapy trials, and considerations for both settings are addressed. The potential importance of keeping patients who show signs of early tumor progression on a study from which they may subsequently benefit later is also discussed. These are both important steps forward, based on the lessons learned in the field. In short, the recommendations provided by the FDA should streamline the development of complex biologics in immunooncology today.

Click here to read the full review!

Other issue highlights include:

Visit www.immunotherapyofcancer.org to read these articles in full and for more information.

Submit your research to JITC! The Society is pleased to offer SITC members waived article processing charges for manuscripts accepted through 2013. For more information, visit: www.sitcancer.org/journal.

Now Accepting Submissions in:

  • Basic Tumor Immunology
  • Clinical/Translational Cancer Immunotherapy
  • Immunotherapy Biomarkers
  • Reviews/Editorials