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Patent US10753935

Prognostic Method And Kits Useful In Said Method

The invention generally relates to diagnostic, prognostic, and monitoring methods and assays for breast cancer and kits that may be used in such methods. More particularly, the invention relates to a method of prognosis of a patient afflicted with breast cancer, including determining the level of HER2/CB.sub.2 heteromer expression in a biological sample obtained from the patient.

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1 Independent Claims

  • Claim 1. A method comprising: providing a test sample comprising a biological sample from a subjectcontacting the test sample with a HER2/CB.sub.2 heteromer binding compositioncomprising one or more antibodies that specifically bind to a HER2/CB.sub.2 heteromer, wherein the one or more antibodies comprise anti-HER2 antibodies, anti-CB.sub.2 antibodies, or both, or one or more antigen-binding fragments of the one or moreantibodies to form a mixtureincubating the mixture for a time sufficient to permit bindingdetermining from the mixture a level of HER2/CB.sub.2 heteromer in the biological samplecomparing the level of HER2/CB.sub.2 heteromer in the biologicalsample to a standard level of HER2/CB.sub.2 heteromer obtained from normal or cancer-free tissue or from an archived pathology sample containing a known level of HER2/CB.sub.2 heteromer protein expressionclassifying the level of HER2/CB.sub.2heteromer in the biological sample as not detectable, low, or elevated based on the comparisonand treating the subject classified as having an elevated level of HER2/CB.sub.2 heteromer by administering a pharmaceutical agent capable of disrupting aHER2/CB.sub.2 heteromer, wherein the pharmaceutical agent capable of disrupting the HER2/CB.sub.2 heteromer is .DELTA..sup.9-tetrahydrocannabinol.

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