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news.Asterand has revealed a new test that may be important in predicting problems before a drug is tested in live human volunteers. The company's scientists believe the test may have been helpful in screening TeGenero's drug candidate that recently caused severe reactions in a group of six men in a clinical trial in the UK.
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The test was developed by a team of five scientists at the US laboratories of Asterand and a summary of their work was recently published in the journal Clinical Cancer Research.
The test utilizes an existing technology known as immunohistochemistry (IHC). Asterand scientists have developed a highly sensitive IHC technique for testing human or humanized antibodies being considered as drug candidates for possible side effects.
The unmodified antibody under consideration is used to stain a range of human tissues – some containing the target protein or tumor as well as normal tissue representing different parts of the body. Some of these tissues may contain the target protein and whether the target is being expressed in diseased or normal tissue can easily be determined.
“These antibodies theoretically bind to a very specific target,” says Dr Alexey Glazyrin, one of the leaders of the Asterand scientific team. “However, no one can guarantee by animal testing that the antibody does not also bind to other cells in the human body. If this happens a type 2 allergic reaction can be triggered with the immunity system launching a massive attack against the cells attached to the antibodies, as possibly happened with the drug in the recent British trial.”
“Until now,” he continued, “tests to detect the reaction to antibody drug candidates have been difficult to interpret because of the background ‘noise’ of other antibodies within the human body; however, the new Asterand assay is highly sensitive and we are able to obtain a clear picture of the reaction of a particular human or humanized antibody.”
The company has used the new procedure to test more than 20 antibodies being considered as drug candidates. According to Dr Glazyrin, many of these antibodies were found to also bind to normal tissue, and the antibody developers were able to review their study plans before human testing began.
“We strongly suspect that a preliminary IHC test on our normal tissue array routinely performed in Asterand could have possibly predicted the unfortunate event in the recent British trial,” Dr Glazyrin added.
Dr Glazyrin also said that he believes the new test will be increasingly valuable because of the ever-growing number of human or humanized antibodies being used as drugs. One example of such a drug is Genentech’s breast cancer therapy Herceptin. Asterand has demonstrated that its new test detects a slightly different subset of patients that may be considered for treatment by the drug compared to the population indicated by current commercially available IHC tests.