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12 Nov 2021

Hoth Therapeutics and WuXi strike API and drug product deal for cancer therapeutic

WuXi will use its new modality platform to provide an end-to-end solution for oligonucleotide peptide

China's WuXi STA has signed two contracts with Hoth Therapeutics, a clinical-stage biopharmaceutical company, for the process development and manufacturing of the API and formulation of drug product for the continued development and commercialisation of HT-KIT.

HT-KIT is Hoth's a new molecular entity (NME) morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers and anaphylaxis.

Through the agreements, the two companies expect 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 will utilise its integrated CRDMO (contract research development and manufacturing organisation) new modality platform to provide an end-to-end solution for oligonucleotide peptide as well as their conjugates for both API and formulation under one roof.

The company has already begun the HT-KIT API process development for manufacturing and expects to yield small-scale material during the first quarter of 2022.

API manuacturing will be immediately followed by initiation of formulation development for HT-KIT, which Hoth intends to develop as a parenteral formulation for injection.

Hoth has said it intends to pursue a pre-IND meeting with the FDA after completion of formulation development.

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