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Hoth Therapeutics Sign API and Drug Product Contracts with WuXi STA to Advance Manufacturing of HT-KIT

Thursday, December 09, 2021

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.

About HT-KIT
HT-KIT is a new molecular entity (NME) under development for treatment of mast cell derived cancers and anaphylaxis. HT-KIT was developed Dr. Glenn Cruse, Assistant Professor at North Carolina State University and shares the same molecular class as Hoth’s current HT-004 drug. The HT-KIT drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem cells. Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and mast cell-derived cancers (mast cell leukemia and mast cell sarcoma). Based on the initial proof-of-concept success, Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis. The same target, KIT, also plays a key role in mast cell-mediated anaphylaxis, a serious allergic reaction that is rapid in onset and may cause death. Anaphylaxis typically occurs after exposure to an external allergen that results in an immediate and severe immune response. Hoth also intends to pursue the anaphylaxis indication for HT-KIT in parallel to cancer treatment and HT-004 development.

About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers & anaphylaxis and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19.  To learn more, please visit https://ir.hoththerapeutics.com/

About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CDMO), WuXi STA offers its worldwide partners efficient, flexible, and high-quality solutions for integrated chemical, manufacturing, and control (CMC) from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com

For media enquiries, please contact:

Abdul Khalifeh or Alex Heeley
De Facto Communications
M: +44 (0) 746 331 7575
T: +44 (0) 203 735 8165
E: a.khalifeh@defacto.co.uk / a.heeley@defacto.co.uk

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