On May 26, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) ("Hoth" or the "Company"), a clinical-stage biopharmaceutical company, reported that the U.S. Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for Hoth’s HT-KIT therapeutic.
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The allowed claims cover antisense oligomers of 25 to 50 linked nucleosides directed to splicing-relevant regions of the MS4A6A pre-mRNA, including intron 3, exon 4, and the intron 3/exon 4 junction, together with pharmaceutical compositions and methods for modulating MS4A6A mRNA splicing in cells or tissues. Hybridization of the disclosed oligomers is intended to reduce cell-surface expression of the high-affinity IgE receptor (FcεRI), a central driver of mast cell activation in allergic and inflammatory disease.
Strategic Importance
Foundational IP Position. Allowance establishes composition-of-matter coverage for the Company’s lead antisense oligomer (SEQ ID NO: 22), including modified, morpholino, and pharmaceutical composition embodiments, providing a defensible basis for the underlying chemistry of the platform.
Mechanistic Differentiation. By reducing surface expression of FcεRI via exon-skipping of MS4A6A pre-mRNA, the approach addresses a node upstream of histamine release and IgE-mediated degranulation, distinct from antihistamine, anti-IgE antibody, and small-molecule mast cell inhibitor approaches.
Broad Indication Coverage. Allowed method claims and related disclosures span asthma, atopic dermatitis, chronic rhinitis, allergic conjunctivitis, chronic sinusitis, anaphylaxis prevention, and mast cell–driven diseases including mastocytosis and mast cell tumors.
Reinforces HT-KIT. The allowed claims strengthen the intellectual property foundation underlying HT-KIT, the Company’s orphan drug–designated program for mast cell–driven disease.
Combination Optionality. The application as filed also describes combination approaches with antisense oligomers targeting FcεRIβ (MS4A2) pre-mRNA splicing, supporting future development of dual-target compositions.
Management Commentary
"This Notice of Allowance is a meaningful validation of the science underlying our mast cell platform and an important addition to the intellectual property foundation supporting HT-KIT," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.
About HT-KIT
HT-KIT is Hoth Therapeutics’ orphan drug–designated program directed at mastocytosis and other mast cell–driven diseases. The program is built around antisense oligomer–mediated modulation of pre-mRNA splicing to reduce pathological mast cell signaling. Hoth expects to finalize its IND submission in 2026, followed by first-in-human studies.
Biotechnology Operations Continue Under Subsidiary Structure
The Company ‘s is exploring placing its biotechnology pipeline and therapeutic development programs under a separate, wholly owned subsidiary with dedicated management and operational resources. The restructuring is intended to preserve the value of the biotechnology portfolio for shareholders while enabling the parent company to pursue emerging opportunities in AI semiconductor infrastructure and advanced computing technologies.
(Press release, Hoth Therapeutics, MAY 26, 2026, View Source [SID1234666067])