On March 24, 2024, Hoth Therapeutics, Inc. ("Hoth" or the "Company") entered into a Project Order Agreement (the "Agreement") with OnTargetx R&D Inc. ("OnTargetx") pursuant to the terms of an existing Master Service Agreement originally entered into on November 8, 2024 (Filing, Hoth Therapeutics, MAR 24, 2025, View Source [SID1234651459]).
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Under the Agreement, OnTargetx, in collaboration with ITR Laboratories, will perform a 4-week intravenous injection toxicity study followed by a 14-day recovery period in C57BL/6 mice, referred to as Study No. 701821 (P210614002-B). The study includes dose formulation, toxicokinetic analysis, clinical pathology, necropsy, histopathology, and detailed reporting. A total of 448 main study animals and 44 spares will be used.
The study has been designed to test the Company’s proposed treatment for mast-cell derived cancers (HT-KIT), with respect to which the Company has an exclusive, worldwide, royalty bearing license to certain intellectual property to, among other things, discover, develop, make, have made, use and sell certain licensed products and sell, use and practice certain licensed services with respect to cancer (and anaphylaxis) from North Carolina State University ("NC State").
Recently, the Company, in conjunction with NC State, filed amendments to a pending patent application related to its antisense oligonucleotide (ASO) technology platform. The amended claims broaden and clarify the scope of intellectual property protections around antisense oligomers targeting specific pre-mRNA sequences involved in gene expression and immune response pathways.
The amended claims include compositions and methods involving antisense oligomers designed to modulate splicing of specific genes and reduce expression of immune-related cell surface receptors. The claims also describe potential pharmaceutical compositions and therapeutic uses across various species.
These amendments reflect routine practice and are intended to strengthen the Company’s patent position in anticipation of further preclinical development and potential licensing discussions.