Turning Point Therapeutics Initiates TRIDENT-2 Clinical Study Investigating Repotrectinib-Trametinib Combination in KRAS G12D Mutated Advanced Solid Tumors
August 16 2021 - 9:00AM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision
oncology company developing next-generation therapies that target
genetic drivers of cancer, today announced initiation of the first
cohort of its Phase 1b/2 TRIDENT-2 combination study of lead
investigational drug repotrectinib. The initial cohort will
investigate repotrectinib in combination with MEK-inhibitor
trametinib in KRAS G12D mutated advanced solid tumors.
“We are pleased to initiate the TRIDENT-2 study and explore a
potential new treatment option for patients with KRAS-driven solid
tumors,” said Mohammad Hirmand, executive vice president and chief
medical officer. “With preclinical studies demonstrating
repotrectinib’s ability to inhibit JAK2, SRC and FAK, our goal is
to help improve the effectiveness of KRAS-targeting agents by
suppressing known pathways of tumor resistance.”
The Phase 1b portion of the study will examine the safety,
tolerability, pharmacokinetics, and any early signals of efficacy
of repotrectinib in combination with trametinib in patients with
KRAS G12D mutated advanced solid tumors. After determination of a
recommended Phase 2 combination dose, the study includes a Phase 2
dose expansion portion with the primary endpoint of objective
response rate.
Results from preclinical studies presented at the 2021 American
Association for Cancer Research annual meeting found that
repotrectinib in combination with trametinib was more effective
than single-agent trametinib in patient-derived KRAS mutant G12D
lung cancer models. The repotrectinib-trametinib combination
suppressed a broad range of downstream mutant KRAS G12D signaling,
increased cell cycle arrest and induction of apoptosis, and was
more active in multiple KRAS G12D dependent models compared to
either single-agent treatment.
The frequently mutated Kirsten Rat Sarcoma (KRAS) viral oncogene
is associated with a broad range of human cancers, including
approximately 30% of non-small cell lung, 40% of colorectal and
more than 90% of pancreatic cancers. KRAS G12D mutations are known
to occur across multiple tumors types, including an estimated 30%
of pancreatic, 15% of colorectal and 5% of both endometrial and
non-small cell lung cancers.
Therapeutic targeting of KRAS has proven challenging, in part
due to resistance and adaptive upregulation of alternative
signaling pathways that promote tumor cell survival, as well as
concurrent secretion of various cytokines and growth factors.
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. Such
forward-looking statements include statements regarding, among
other things, the efficacy, safety and therapeutic potential of
repotrectinib, the results, conduct, progress and timing of Turning
Point Therapeutics’ pre-clinical studies and clinical trials and
plans regarding future clinical trials. 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 SEC,
including its quarterly report on Form 10-Q filed with the SEC on
August 9, 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: Scott Lipmanir@tptherapeutics.com858-876-3985
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