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:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
View original content to download
multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-positive-results-killing-cancer-cells-in-both-gastrointestinal-stromal-tumors-and-acute-myeloid-leukemia-301925746.html
SOURCE Hoth Therapeutics, Inc.