HT-KIT received Orphan Drug Designation from
FDA for its mRNA Frame Shifting Cancer Therapeutic
Hoth intends to initially target mast cell
neoplasms for development of HT-KIT, which is a rare, aggressive
cancer with poor prognosis
NEW
YORK, Sept. 11, 2023 /PRNewswire/ -- Hoth
Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused
biopharmaceutical company, today announced it has submitted a
request for a Pre-Investigational New Drug (IND) meeting to the
U.S. Food and Drug Administration (FDA) to discuss the proposed
drug development program for HT-KIT, a new molecular entity, for
the treatment of advance systemic mastocytosis (AdvSM). 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.
Currently in the preclinical stage of development of HT-KIT,
Hoth anticipates a meeting with the FDA to be scheduled during the
fourth quarter of 2023. During the pre-IND meeting with the FDA,
Hoth Therapeutics plans to discuss the overall proposed drug
development program for HT-KIT including requirements for
nonclinical, clinical pharmacology, clinical, chemistry, and
manufacturing controls. Hoth also plans to present clinical trial
designs for the IND-opening, phase 1 dose ranging and dose
extension studies as well as a proposed follow-up phase 2 safety
and efficacy study; both studies will be conducted in adult
patients with advanced systemic mastocytosis (AdvSM). AdvSM
includes patients with aggressive systemic mastocytosis (ASM),
systemic mastocytosis with an associated hematological neoplasm
(SMAHN), and mast cell leukemia (MCL).
"Today's FDA submission brings us one step closer to advancing
HT-KIT for patients who are suffering with a rare aggressive form
of cancer," stated Robb Knie,
Chairman and CEO of Hoth Therapeutics. "We look forward to
working closely with the FDA and advancing HT-KIT through the
IND-enabling and clinical phases of development."
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-fda-accepts-pre-investigational-new-drug-pre-ind-submission-for-ht-kit-treatment-for-cancer-patients-301923392.html
SOURCE Hoth Therapeutics, Inc.