Turning Point Therapeutics Granted FDA Orphan Drug Designation for TPX-0022 in Gastric Cancer
June 17 2021 - 8:30AM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision
oncology company developing next-generation therapies that target
genetic drivers of cancer, today announced that TPX-0022, the
company’s inhibitor of MET and the associated cancer signaling
pathways of SRC and CSF1R, has been granted orphan drug designation
by the Food and Drug Administration (FDA) for the treatment of
patients with gastric cancer, including gastroesophageal junction
adenocarcinoma.
“Aberrant signaling and genomic alterations in MET-driven
gastric cancers are associated with a poor prognosis for patients,
creating a high unmet need for therapies to target the molecular
drivers of the disease,” said Mohammad Hirmand, M.D., chief medical
officer. “We are pleased to receive this designation for TPX-0022
as we work to develop it as a potentially differentiated option for
patients affected by MET-driven gastric cancer.”
There are currently no approved MET inhibitors for the treatment
of gastric cancer and gastroesophageal junction adenocarcinoma.
TPX-0022 is a potent inhibitor of the MET tyrosine kinase and
has the potential to modulate the tumor microenvironment to augment
its therapeutic effect. Initial clinical data presented from the
ongoing Phase 1 SHIELD-1 study in October 2020 showed TPX-0022 has
been generally well-tolerated and demonstrated clinical activity in
patients with MET-amplified gastric cancer.
Orphan Drug Designation is granted by the FDA to assist in the
development of drug candidates that may offer therapeutic benefits
for diseases with a prevalence of fewer than 200,000 patients
annually. Benefits of the designation may include the opportunity
for accelerated approval, discounts on registration fees, tax
credits for qualified clinical trials and eligibility for 7 years
of market exclusivity post-regulatory approval.
About Turning Point Therapeutics Inc.Turning
Point Therapeutics is a clinical-stage precision oncology
company with a pipeline of internally discovered investigational
drugs designed to address key limitations of existing cancer
therapies. The company’s lead drug candidate, repotrectinib, is a
next-generation kinase inhibitor targeting the ROS1 and TRK
oncogenic drivers of non-small cell lung cancer and advanced solid
tumors. Repotrectinib, which is being studied in a registrational
Phase 2 study in adults and a Phase 1/2 study in pediatric
patients, has shown antitumor activity and durable responses among
kinase inhibitor treatment-naïve and pre-treated patients. The
company’s pipeline of drug candidates also includes TPX-0022,
targeting MET, CSF1R and SRC, which is being studied in a Phase 1
trial of patients with advanced or metastatic solid tumors
harboring genetic alterations in MET; TPX-0046, targeting RET,
which is being studied in a Phase 1/2 trial of patients with
advanced or metastatic solid tumors harboring genetic alterations
in RET; and TPX-0131, a next-generation ALK inhibitor, which is
being studied in a Phase 1/2 trial of previously treated patients
with ALK-positive advanced or metastatic non-small cell lung
cancer. Turning Point’s next-generation kinase inhibitors are
designed to bind to their targets with greater precision and
affinity than existing therapies, with a novel, compact structure
that has demonstrated an ability to potentially overcome treatment
resistance common with other kinase inhibitors. The company is
driven to develop therapies that mark a turning point for patients
in their cancer treatment. For more information, visit
www.tptherapeutics.com.
Forward Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Words such as “plans”, “will”,
“believes,” “anticipates,” “expects,” “intends,” “goal,”
“potential” and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements in this
press release include statements regarding, among other things, the
efficacy, safety and therapeutic potential of TPX-0022, the results
of the SHIELD-1 clinical study, and the potential benefits of
Orphan Drug Designation. These forward-looking statements are based
upon Turning Point Therapeutics’ current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with Turning Point Therapeutics’
business in general, risks and uncertainties related to the impact
of the COVID-19 pandemic to Turning Point’s business and the other
risks described in Turning Point Therapeutics’ filings with the
SEC, including its quarterly report on Form 10-Q filed with the SEC
on May 5, 2021. All forward-looking statements contained in this
press release speak only as of the date on which they were made.
Turning Point Therapeutics undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Contact: Jim
Mazzolajim.mazzola@tptherapeutics.com858-342-8272
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