Hoth Therapeutics mRNA Frame-Shifting Therapeutic, HT-KIT, Proves Effective Against Aggressive Cancer Cells

Rhea-AI Summary

Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced significant progress on its cancer therapeutic, HT-KIT. This innovative treatment showed effectiveness in preventing cancer cell growth and inducing cell death in mast cell leukemia models. HT-KIT has been granted Orphan Drug status and successfully completed API manufacturing feasibility. The therapy targets the proto-oncogene KIT, aimed at treating rare cancers such as systemic mastocytosis and acute myeloid leukemia. Hoth is preparing for a Pre-IND meeting with the FDA and pursuing various patent applications to safeguard its intellectual property.

Positive

• HT-KIT demonstrated effectiveness in inhibiting cancer cell growth and inducing cell death in aggressive cancers.
• HT-KIT received Orphan Drug designation, providing regulatory and financial incentives.
• Successful completion of API manufacturing feasibility indicates readiness for further development.
• Initial results open pathways for FDA interactions and potential future approvals.

Negative

• None.

Treatment with HT-KIT prevented cancer cell growth and induced death in neoplastic mast cells over 72 hours

HT-KIT inhibits tumor growth and systemic organ infiltration using both an allograft mastocytosis model and a humanized xenograft MC tumor model.

Orphan Drug status granted, successfully completed API manufacturing feasibility

NEW YORK, April 11, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced a development updates for its novel cancer therapeutic, HT-KIT.

Hoth's innovative approach, which employs a chemically-stable antisense oligonucleotide to target the proto-oncogene KIT through by frameshifting KIT mRNA transcripts, has potential as a KIT-targeted therapeutic alone, or in combination with agents that target KIT signaling, in the treatment of KIT-associated malignancies.

Through a sponsored scientific research agreement with North Carolina State University, the team used the HT-KIT mRNA frame-shifting approach on mast cell leukemia cells in vitro and found that KIT protein expression, signaling and function were reduced. Treatment with HT-KIT prevented cancer cell growth and induced cell death over 72 hours. In a humanized mast cell leukemia mouse model, tumor growth and infiltration of other organs were reduced and tumor cell death increased when HT-KIT induced frameshifted c-KIT mRNA. 

Hoth has filed several patent applications to protect this IP throughout the world.  

"With our HT-KIT drug, we are flipping off a key cancer signal that's involved in multiple aggressive cancers, such as systemic mastocytosis, mast cell leukemia, gastrointestinal stromal tumors and acute myeloid leukemia. Our approach avoids pitfalls related to KIT mutations by targeting mRNA. Our next round of preclinical studies are underway and we are excited to utilize the results for our planned Pre-IND meeting with FDA later this year," stated Robb Knie, Chief Executive Officer of Hoth.

HT-KIT, a new molecular entity, was designated as an Orphan Drug for the treatment of mastocytosis earlier in 2022. HT-KIT Hoth has successfully completed manufacturing feasibility of the HT-KIT drug substance in collaboration with WuXi STA. 

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 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.

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 skin toxicities associated with cancer therapy, mast-cell derived cancers and anaphylaxis, Alzheimer's Disease, atopic dermatitis and other indications. 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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What is HT-KIT and its significance for Hoth Therapeutics?

HT-KIT is a novel cancer therapeutic developed by Hoth Therapeutics targeting the proto-oncogene KIT, showing promise in treating aggressive cancers.

What recent developments have occurred regarding HT-KIT?

Recent developments include HT-KIT's effectiveness in preclinical models, Orphan Drug designation, and completion of API manufacturing feasibility.

What is the next step for Hoth Therapeutics with HT-KIT?

Hoth Therapeutics plans to conduct preclinical studies and prepare for a Pre-IND meeting with the FDA later this year.

What types of cancer could HT-KIT help treat?

HT-KIT is aimed at treating KIT-associated malignancies, including systemic mastocytosis, mast cell leukemia, and gastrointestinal stromal tumors.

How does Orphan Drug status benefit Hoth Therapeutics?

Orphan Drug status provides benefits such as tax credits for clinical costs, assistance in the drug development process, and seven years of post-approval marketing exclusivity.