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Invikafusp alfa is a first-in-class, selective dual T cell agonist designed in a bi-specific antibody format to selectively engage and activate specific T cell subsets. It targets the Vβ6/Vβ10 regions of the T cell receptor (TCR), leading to expansion and activation of these T cells, which are enriched in tumor-infiltrating lymphocytes. This mechanism aims to enhance anti-tumor immune responses, particularly in patients with solid tumors that are resistant to PD-1/PD-L1 checkpoint inhibitors. Invikafusp alfa has demonstrated clinically meaningful antitumor activity as a monotherapy in heavily pretreated patients with advanced or metastatic solid tumors—including those with high tumor mutational burden (TMB-H) colorectal cancer—who have progressed after prior immunotherapy. The drug is being developed by Marengo Therapeutics and has received FDA Fast Track designation for unresectable, locally advanced or metastatic colorectal cancer with high tumor mutational burden[1][4][5][6][7].
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