CAMBRIDGE, Mass., Feb. 2, 2022 /PRNewswire/ -- Theseus
Pharmaceuticals, Inc. (Theseus) (NASDAQ: THRX), a clinical-stage
biopharmaceutical company focused on improving the lives of cancer
patients through the discovery, development and commercialization
of transformative targeted therapies, today announced that the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation (ODD) to the company's lead candidate THE-630, a
small-molecule oral pan-variant KIT inhibitor, for the treatment of
patients with advanced gastrointestinal stromal tumors (GIST).
"We are pleased to have received ODD for THE-630 so quickly
after the initiation of the first-in-human trial. This designation
from the FDA emphasizes the need to bring better therapeutic
options to patients with advanced GIST," said David Kerstein, M.D., Chief Medical Officer at
Theseus. "For patients living with GIST, progression through
standard lines of therapy is often associated with the emergence of
resistance mutations in KIT. We look forward to evaluating the
clinical potential of THE-630 to inhibit these resistance mutations
in patients who've exhausted available therapies and when used in
earlier lines of therapy."
The FDA's Office of Orphan Products Development grants ODD
status to drugs and biologics intended for the safe and effective
treatment, diagnosis or prevention of rare diseases or conditions
affecting fewer than 200,000 people in the United States. ODD provides benefits to
drug developers designed to support the development of drugs and
biologics for small patient populations with unmet medical needs.
These benefits include assistance in the drug development process,
tax credits for qualified clinical costs, exemptions from certain
FDA fees and seven years of marketing exclusivity.
GIST is the most common sarcoma of the
gastrointestinal tract with an estimated 4,000 to 6,000 new cases
diagnosed in the United States
each year. Approximately eighty percent of GIST cases are driven by
mutations that activate the kinase activity of the receptor
tyrosine kinase KIT, and up to ninety percent of all cases of
progression are driven by secondary resistance mutations in
About Theseus Pharmaceuticals, Inc.
Theseus is a
clinical-stage biopharmaceutical company focused on improving the
lives of cancer patients through the discovery, development and
commercialization of transformative targeted therapies. Theseus is
working to outsmart cancer resistance by developing pan-variant
tyrosine kinase inhibitors (TKIs) to target all known classes of
cancer-causing and resistance mutations that lead to variants in a
particular protein in a given type of cancer. Theseus' lead product
candidate, THE-630, is a pan-variant KIT inhibitor for the
treatment of patients with advanced gastrointestinal stromal tumors
(GIST), whose cancer has developed resistance to earlier lines of
kinase inhibitor therapy. Theseus is also developing a
fourth-generation, selective epidermal growth factor receptor
(EGFR) inhibitor for C797S-mediated resistance to first- or
later-line osimertinib treatment in patients with non-small cell
lung cancer (NSCLC). For more information, visit
Cautionary Statement Regarding Forward Looking
Certain statements included in this press release
are not historical facts but are forward-looking statements for
purposes of the safe harbor provisions under the United States
Private Securities Litigation Reform Act of 1995. Forward-looking
statements generally are accompanied by words such as "believe,"
"may," "will," "estimate," "continue," "anticipate," "intend,"
"expect," "should," "would," "plan," "predict," "potential,"
"seem," "seek," "future," "outlook," and similar expressions that
predict or indicate future events or trends or that are not
statements of historical matters, but the absence of these words
does not mean that a statement is not forward-looking. These
forward-looking statements include, but are not limited to,
statements regarding Theseus' strategy, future operations,
prospects and plans, the structure and timing of its planned and
ongoing clinical trials and future registrational trials, expected
milestones, market opportunity and sizing and objectives of
management, including in relation to THE-630 and the Phase 1/2 does
escalation and expansion clinical trial and its EGFR and other
Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, such as those described from time to time in the reports
Theseus files with the Securities and Exchange Commission (SEC),
including Theseus' Form 10-Q for the quarter ended September 30, 2021 filed with the SEC on
November 15, 2021. However, new risk
factors and uncertainties may emerge from time to time, and it is
not possible to predict all risk factors and uncertainties.
Accordingly, readers are cautioned not to place undue reliance on
these forward-looking statements. Any forward-looking statements
contained in this press release are based on the current
expectations of Theseus' management team and speak only as of the
date hereof, and Theseus specifically disclaims any obligation to
update any forward-looking statement, whether as a result of new
information, future events or otherwise.
SOURCE Theseus Pharmaceuticals