NEW YORK, Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, today announced development updates for its cancer therapeutic, HT-KIT after receiving Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) on March 11, 2022. HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting.
Preclinical studies have demonstrated that HT-KIT induces apoptosis of neoplastic mast cells and reduces metastasis associated with aggressive mastocytosis.
Hoth has successfully completed manufacturing feasibility of the HT-KIT drug substance in collaboration with WuXi STA. Hoth plans to pursue a Pre-IND meeting with FDA by the end of 2022.
“With this important step now completed, Hoth has moved drug development into the later stage which will yield us our clinical formulation and allow us to hold our Pre-IND meeting with the FDA this year,” stated Robb Knie, Chief Executive Officer of Hoth.
HT-KIT is a new molecular entity (NME) under development for treatment of mast cell derived cancers and anaphylaxis. HT-KIT was developed Dr. Glenn Cruse, Assistant Professor at North Carolina State University and shares the same molecular class as Hoth’s current HT-004 drug. The HT-KIT drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, 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 gastrointestinal stromal tumors and mast cell-derived cancers (mast cell leukemia and mast cell sarcoma). Based on the initial proof-of-concept success, Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. It’s pipeline development is focused to improve the quality of life for patients suffering from skin toxicities associated with cancer therapy, mast-cell derived cancers and anaphylaxis, Alzheimer’s Disease, atopic dermatitis and other indications.
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