Hoth Therapeutics, Inc., (NASDAQ: HOTH) a patient focused biopharmaceutical company, announced today that it has entered into two 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.
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 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.
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
This press release includes forward-looking statements based upon Hoth’s current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth’s business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management’s expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled “Risk Factors” in Hoth’s most recent Annual Report on Form 10-K and Hoth’s other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
SOURCE Hoth Therapeutics, Inc.