Hoth and WuXi sign API process development agreement

14-Dec-2021

The companies intend to develop the therapy as a parenteral formulation for injection

Hoth Therapeutics, a biopharmaceutical company, has entered an agreement with STA Pharmaceutical, a subsidiary of WuXi AppTec, for process development and manufacturing of the API and formulation of drug product for HT-KIT. HT-KIT is a morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers and anaphylaxis.

The agreements between Hoth and WuXi are hoped to accelerate the development of this therapy with PMO manufacturing scale-up from feasibility batches to GMP material. Wuxi is able to provide an end-to-end platform for oligonucleotide, peptide as well as their conjugates for both API and formulation under one roof, the company claims.

API process development for manufacturing is already underway, and is expected to yield small-scale material in early 2022, which will be immediately followed by initiation of formulation development. The companies intend to develop the therapy 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, CSO 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."

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"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.

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