• Gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT.
• HT-KIT Shows Positive Results in AML
• Positive Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University

NEW YORK, Sept. 13, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM) achieved positive preclinical results in a study sponsored by Hoth. HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.

The sponsored preclinical research was conducted at NC State University ("NCSU") over the past two years. The aim of the initial studies was to assess how long HT-KIT was functional in cancerous and non-cancerous mast cells, and to determine whether the cells could develop resistance to HT-KIT. Key findings from initial studies in the mouse model show:

• HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive.
• The effects of a single dose of HT-KIT lasted for about 2 weeks.
• HT-KIT efficacy at reducing KIT expression lasted for 7 days

Additional studies were then performed to assess whether HT-KIT had potential applications further to the mastocytosis indication. Gastrointestinal stromal tumors (GISTs) are also associated with activating KIT mutations. Key findings from these studies show:

• HT-KIT potently reduced KIT expression using GIST cells and that GIST cells rapidly died between 48 and 72 hours after exposure to HT-KIT.
• Further, we also examined the effects of HT-KIT on a cell line that represents acute myeloid leukemia (AML) cells, and found KIT expression was lower in the AML cells compared to either the mastocytosis or GIST cells, but was effectively and dose-dependently reduced with HT-KIT treatment over 72 hours.

Overall, these data provide strong support for potential applications of HT-KIT outside of mastocytosis and mast cell leukemia where KIT may be expressed and could play a role in disease aggression. Further in vivo and mechanistic studies are underway at NCSU in these diseases.

"The results from our HT-KIT preclinical trial further reinforces our belief that targeting mutations in the KIT pathway could be the answer for patients living with mast cell-derived cancers and related conditions," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to leveraging these results in our program development as we prepare to meet with the FDA before year end."

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. HT-KIT has Orphan Drug Designation from the FDA. FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

About Hoth Therapeutics, Inc. 

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/ .

Forward-Looking Statement 

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.

Investor Contact: 
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