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.