Turning Point Therapeutics Provides Regulatory Update for Repotrectinib for the Treatment of ROS1+ Advanced NSCLC
July 27 2022 - 4:05PM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage
precision oncology company designing and developing novel targeted
therapies for cancer treatment, today announced receipt of positive
feedback from the U.S. Food and Drug Administration (FDA) at a
pre-New Drug Application (NDA) meeting completed within the second
quarter. The feedback focused on the planned patient follow-up
within the ROS1+ advanced non-small cell lung cancer (NSCLC)
patient cohorts of the ongoing TRIDENT-1 registrational study of
repotrectinib, the company’s lead drug candidate, which is a
potential best-in-class ROS1 tyrosine kinase inhibitor that has
received two breakthrough therapy designations within ROS1+
advanced NSCLC.
The purpose of the pre-NDA meeting was to discuss the company’s
planned NDA for repotrectinib for the treatment of ROS1+ advanced
NSCLC. The FDA agreed with the company’s plan to provide data for
ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at
least six months of follow-up from the first post-baseline scan at
the time of NDA submission.
“We continue to be encouraged by our collaborative meetings with
the FDA,” said Mohammad Hirmand, M.D., Chief Medical Officer. “The
planned NDA submission represents an important milestone for our
company. The unmet need in ROS1+ advanced NSCLC patients is
significant, and we continue to believe that repotrectinib could
offer a best-in-class profile for the treatment of these
patients.”
About Turning Point Therapeutics
Inc.Turning Point Therapeutics is a clinical-stage
precision oncology company with a pipeline of 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 elzovantinib,
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; 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; and
TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 being studied
in a Phase 1 study in gastrointestinal cancers. 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. Such
forward-looking statements include statements regarding, among
other things, the anticipated timing for completing an NDA
submission for repotrectinib for the treatment of ROS1+ advanced
NSCLC, and the potential best-in-class profile of repotrectinib.
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. 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
Securities and Exchange Commission (SEC), including its quarterly
report on Form 10-Q filed with the SEC on May 10, 2022. 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: Adam D. Levy, PhD,
MBAir@tptherapeutics.com858-867-6366
Turning Point Therapeutics (NASDAQ:TPTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Turning Point Therapeutics (NASDAQ:TPTX)
Historical Stock Chart
From Sep 2023 to Sep 2024