Hoth Therapeutics, Inc., a patient focused biopharmaceutical company, announced today that it has entered into contracts with STA Pharmaceutical, a subsidiary of WuXi AppTec (WuXi STA), 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 (NME) morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers (aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)) and anaphylaxis.
These 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 Q1 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.
"Initiation of API and drug formulation development is a huge leap towards getting HT-KIT into clinical trials, which is a large focus for Hoth Therapeutics in the next year,” said Dr. Stefanie Johns, PhD, Chief Scientific Officer of Hoth Therapeutics. "We are confident in WuXi STA’s experience in manufacturing morpholino oligonucleotides for clinical and commercial applications to help expedite our program for HT-KIT."
"We are excited to collaborate with Hoth Therapeutics on this exciting next-generation therapy with far-reaching potential in oncology and beyond. This signing of this contract demonstrates our integrated new modality CRMDO platform is highly trusted by the customers. We are looking forward to accelerating this innovative therapy for the benefit of global patients." said Dr. Minzhang Chen, Co-CEO of WuXi AppTec.
After completion of formulation development, Hoth intends to pursue a Pre-IND meeting with the US FDA.
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