Dextramers are superior reagents for the detection of antigen-specific T cells, having the ability to interact simultaneously with multiple receptors on a single T cell with unsurpassed avidity. The increased avidity of Dextramers compared to conventional MHC multimer reagents enhances resolution and signal-to-noise ratio providing a more accurate assessment of the T cell response, and clearly identifying responses previous generation technologies might miss.

In compliance with cGLP quality standards, IST specializes in incorporating antigen-specific responses in assay solutions to evaluate the safety and efficacy of vaccines and biologics.  IST offers expertise in confirming the validity of processes involved in such studies. Together with Immudex’s Dextramer™ technology, IST now offers enhanced capabilities to validate the effectiveness of potential vaccines and biologics, and thereby significantly improve the efficiency and cost-effectiveness of drug development and production.

Through the partnership, IST can refer clients that need to gauge T cell response to Immudex, and Immudex can refer clients that have other immune monitoring needs to IST. IST immune monitoring services include custom assay design, optimization, automation and validation; cell mediated immunity; functional immune monitoring and much more. This alliance adds to the capabilities of both companies while streamlining processes – providing for faster, more accurate results for customers. By accurately gauging the effect of an immunotherapy, researchers can reduce a study’s timeline by weeks or even months, and more importantly, can avoid wrong and costly decisions based on weak and inaccurate data. This can prove invaluable during all phases of clinical trials, driving significant cost savings and productivity.

“If you’ve ever been on a conference call with eight separate vendors trying to figure out if a pharmaceutical is working, then you’ll understand why this partnership is beneficial to our industry,” said Wade Bolton, Ph.D., President of IST. “Immudex offers a technology that is superior in gauging T cell responses and we’re honored to call them partners.”

“IST’s standardization, validation and automation of custom assays are the best in the industry,” said Stephen Haley, Ph.D., Vice President and Director of U.S. Operations for Immudex. “This partnership greatly increases our offering capabilities and is poised to be a great asset to our current and future clients.”

The alliance is not an exclusive partnership. IST still has the ability to use other technologies when deemed more appropriate or to meet a client’s request.

For more information on ImmunoSite Technologies, please visit http://immunositetechnologies.com/; follow IST on Twitter at http://twitter.com/ImmunoSite; or follow on Facebook at http://www.facebook.com/pages/ImmunoSite-Technologies-LLC/167604859950599. For more information on Immudex, visit http://www.immudex.com/.

About ImmunoSite Technologies

Based in Ft. Lauderdale, FL, ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) immune monitoring services to leading biotechnology, pharmaceutical, and academic organizations around the world to provide products and services that span all stages of drug discovery and development. IST is rapidly building a worldwide reputation for services related to qualifying, standardizing, and when appropriate, automating assays associated with cell-mediated immunity. By using qualified reagents, controls, standards and processes, IST-developed functional assays perform within tight specifications and yield reproducible results, helping pharmaceutical and biotechnology companies to accelerate drug discovery, document clinical relevance and reduce costs. The IST team has been distinguished by their ongoing partnerships with best-in-class clinical trial organizations such as: the Immune Tolerance Network, the Immune Tolerance Institute, and the Imperial College of London-managed CD4 Initiative. This extensive cell analysis R&D experience qualifies IST scientists to comply with complex and demanding international scientific and governmental regulations.

About Immudex

Based in Copenhagen, Denmark with North American operations based in Fairfax, Virginia, Immudex is the sole proprietor of the MHC Dextramer technology. Immudex develops and commercializes products for the quantitation, characterization, and generation of antigen-specific T-cell responses for life science research, in vitro diagnostics and vaccine development. Immudex has a number of Research Use Only (RUO) products on the market, two products under development for in vitro diagnostic use, as well as a vaccine candidate in development for one of the most deadly of human diseases.

Press Contact:

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Kyle E. Glass, Public Relations/Marketing Manager

Ph: 502-409-5953

Email: kyle@marketingmatters.net

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As Immunologists, we are encouraged by the fact that the FDA approved the biotech drug known chemically as ipilimumab, even though it only worked in a small segment of patients studied, and on average they lived just four months longer than patients given older medications. Ipilimumab is part of a group of targeted cancer medicines that harness the body’s immune system to fight off cancer, rather than attacking the disease with outside chemicals like chemotherapy. The drug works by blocking a molecule linked to immune cell response called CTLA-4, and maintaining activity of white blood cells. When the molecule is blocked, the cells maintain an “activated phenotype” and are able to fight off cancer.

The fact that Yervoy (ipilimumab) proved to prolong life for some patients is a good start in finding more effective ways to treat melanoma, which is often unresponsive to therapy.  While some will argue the value of the cost and time involved for this result, experts in immune monitoring and surveillance see promising research progress that may someday soon lead to more significant and meaningful treatments for those suffering from metastatic melanoma.

Two-tiered strategy may improve outcome for treating melanoma

Why is it an important milestone for treating melanoma? “If a single biologic, CTLA4, enhances the outcome, now researchers have the capability of adding in therapeutic strategies that are scientifically relevant to hopefully further improve the outcome”, says Sybil D’Costa, Ph.D., VP of R&D at ImmunoSite Technologies. 

For example, D’Costa suggests a two-tiered strategy that would be immunologically relevant and scientifically sound: possibly a “tickle” of melanoma specific T cells with DCs pulsed with melanoma peptides, and then the CTLA4 therapy to lengthen the timeline of the activation. This would also limit the immune-related side effects by targeting the immune response to the cancer.

In that instance the immune monitoring panels would be:

1. An evaluation of Dendritic cell function pre and post autologous cancer presenting Dendritic cell pulse

2. A determination of downstream effects of the DC pulse by evaluating surface activation and rafting of cancer specific CD4 and CD8 pre and post DC pulse and CTLA4 treatment

3. An evaluation of antigen specific functionality in helper and cytotoxic T cells pre and post CTLA4 treatment

4. An evaluation of shift in T regulatory cell activity

5. An evaluation of Tumor infiltrating lymphocytes in comparison to antigen (cancer) specific circulating lymphocytes

Such combinatorial strategies that are scientifically relevant are already being discussed and evaluated in the literature: 2011 Apr 5. CTLA-4 blockade increases antigen-specific CD8(+) T cells in prevaccinated patients with melanoma: three cases. http://www.ncbi.nlm.nih.gov/pubmed/21465316.

Contract Research Organizations (CROs) like ImmunoSite Technologies (IST) are very involved with pre-clinical and clinical research to assist drug and biologic companies in developing immune monitoring assays to assess the performance of drugs such as this.  While the initial results may be marginal, the progress towards a better drug treatment is clear.  It is significant that the FDA has approved the drug Yervoy for late-stage or metastatic melanoma. It should encourage more drug research approaches such as the two-tiered strategy outlined here.

Progress leads to more questions

Do you agree that the drug Yervoy (ipilimumab) has proven to be a “significant milestone” in treating melanoma?

What are your thoughts on the two-tiered strategy outlined in this post?  How would you amend it?

What are your thoughts on the potential for future cancer medicines that harness the body’s immune system to fight off cancer?  What research would you like to see conducted?

Update:  Two-tiered Strategy Proves Successful at Dana Farber Cancer Institute

In an April 27th announcement (http://www.dana-farber.org/abo/news/press/2011/new-technique-extends-cancer-fighting-cells-potency-in-melanoma-patients.html), the Dana Farber Cancer Institute talks about successful use of a two-tiered or combinational strategy for immune modulation in cancer.  This small study supports the two-tiered strategy suggested in this post.  In the Dana Farber Cancer Institute study, the positive results, five of five patients seemed to respond, indicate that such a combinational strategy would in fact help make a drug like Ipilimumab a scientifically relevant drug for immune modulation in cancer.

IST quite literally helped “write the book” on cell analysis testing.  They were asked to contribute a chapter of a book titled Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, by authors/editors Uma Prabhakar and Marian Kelley (Publisher John Wiley and Sons, 2008, ISBN 0470028769, 9780470028766).  Chapter 8 of this book entitled “Intracellular cytokine detection by flow cytometry” was authored by IST scientists Julie G. Wilkinson, Carlos L. Aparicio, and Wade E. Bolton.

Readers gain an understanding of the details and the high level considerations of assay qualification for difficult cell-based assays.  The level of optimization described for cell-based assays lends itself to biomarker assay automation which can be used for biomarker qualification and validation studies to the satisfaction of the FDA, EMEA, and other regulatory agencies.   Cell-based assay platforms covered are flow cytometry, intracellular cytokine ICS, immunophenotyping, elispot, IHC, cylex, neutralization bioassays, and endpoint assays.