HT-KIT is an mRNA frame-shifting therapeutic designed to specifically target the receptor tyrosine kinase KIT, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem cells. Mutations in the KIT pathway have been associated with several human cancers, such as mast cell-derived cancers, systemic mastocytosis with associated hematologic neoplasm, or mast cell leukemia, gastrointestinal stromal tumors, and acute myeloid leukemia.The preclinical animal trials were conducted using humanized mast cell neoplasm models, representative in vitro and in vivo models for aggressive, mast cell-derived cancers, such as mast cell leukemia and mast cell sarcoma. Key findings of the mouse models found that HT-KIT:
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- Reduces KIT expression and induces apoptosis of neoplastic human mast cells
- Inhibits tumor growth in humanized xenograft mast cell neoplasia models
- Reduces liver infiltration of neoplastic mast cells
- Reduces tumor growth in isograft models of mast cell neoplasia
- Reduces signs of mast cell leukemia in an isograft model of mutant mast cell neoplasia
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