Hoth Therapeutics, Inc. announced that it has entered into two contracts with STA Pharmaceutical, a subsidiary of WuXi AppTec, for process development and manufacturing of the active pharmaceutical ingredient (API) and formulation of drug product for the continued development and commercialization of HT-KIT. HT-KIT is a new molecular entity morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers (aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia and anaphylaxis. The agreements between Hoth Therapeutics and WuXi STA are expected to accelerate the development of this new modality therapy with rapid and efficient PMO manufacturing scale-up from feasibility batches to GMP material.

WuXi STA's unique integrated CRDMO (Contract Research Development and Manufacturing Organization) new modality platform provides an end to end solution for oligonucleotide peptide as well as their conjugates for both API and formulation under one roof. The HT-KIT API process development for manufacturing is already underway, expecting to yield small scale material in First Quarter 2022. Production of API will be immediately followed by initiation of formulation development for HT-KIT.

Hoth intends to develop HT-KIT as a parenteral formulation for injection. After completion of formulation development, Hoth intends to pursue a Pre-IND meeting with the US FDA.