CAMBRIDGE, Mass., July 16,
2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:
NUVL), a clinical-stage biopharmaceutical company focused on
creating precisely targeted therapies for
clinically proven kinase targets in cancer, today announced that
updated data from the ARROS-1 Phase 1/2 clinical trial of
zidesamtinib and ALKOVE-1 Phase 1/2 clinical trial of NVL-655, will
be presented during two oral presentations at the European Society
for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain.
Details for the presentations are as follows:
Title: Phase 1/2 ALKOVE-1 study of NVL-655 in
ALK-positive (ALK+) solid tumors
Presentation Number: 1253O
Session Category: Proffered paper session
Session Title: NSCLC metastatic
Presentation Date and Time: Saturday September 14,
2024, 9:40 – 9:50 CEST
Location: Barcelona Auditorium – Hall 2
Presenter: Alexander Drilon, M.D. (Memorial Sloan
Kettering Cancer Center, New York,
USA)
Title: Phase 1/2 ARROS-1 study of zidesamtinib (NVL-520)
in ROS1 fusion-positive solid tumors
Presentation Number: 1256MO
Session Category: Mini oral session
Session Title: NSCLC metastatic
Presentation Date and Time: Saturday September 14,
2024, 10:30 – 10:35 CEST
Location: Santander Auditorium – Hall 5
Presenter: Benjamin Besse, M.D., Ph.D. (Institut Gustav
Roussy, Villejuif, France)
Additionally, the company will present new preclinical data
further characterizing the intracranial activity of zidesamtinib
during a poster session. The title is:
Title: Profiling of Zidesamtinib and Other ROS1
Inhibitors in an Intracranial CD74-ROS1 G2032R Preclinical
Model
Abstract Number: 4811
Presenter: Anupong Tangpeerachaikul (Nuvalent, Inc.,
Cambridge, Massachusetts,
United States)
About zidesamtinib
Zidesamtinib is a novel
brain-penetrant ROS1-selective inhibitor created with the aim to
overcome limitations observed with currently available ROS1
inhibitors. Zidesamtinib is designed to remain active in tumors
that have developed resistance to currently available ROS1
inhibitors, including tumors with treatment-emergent ROS1 mutations
such as G2032R. In addition, zidesamtinib is designed for central
nervous system (CNS) penetrance to improve treatment options for
patients with brain metastases, and to avoid inhibition of the
structurally related tropomyosin receptor kinase (TRK) family.
Together, these characteristics have the potential to avoid
TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors
and to drive deep, durable responses for patients across all lines
of therapy. Zidesamtinib has received breakthrough therapy
designation for the treatment of patients with ROS1-positive
metastatic non-small cell lung cancer (NSCLC) who have been
previously treated with 2 or more ROS1 tyrosine kinase inhibitors
and orphan drug designation for ROS1-positive NSCLC. Zidesamtinib
is currently being investigated in the ARROS-1 trial (NCT05118789),
a first-in-human Phase 1/2 clinical trial for patients with
advanced ROS1-positive NSCLC and other solid tumors.
About NVL-655
NVL-655 is a novel brain-penetrant
ALK-selective inhibitor created with the aim to overcome
limitations observed with currently available ALK inhibitors.
NVL-655 is designed to remain active in tumors that have developed
resistance to first-, second-, and third-generation ALK inhibitors,
including tumors with single or compound treatment-emergent ALK
mutations such as G1202R. In addition, NVL-655 is designed for
central nervous system (CNS) penetrance to improve treatment
options for patients with brain metastases, and to avoid inhibition
of the structurally related tropomyosin receptor kinase (TRK)
family. Together, these characteristics have the potential to avoid
TRK-related CNS adverse events seen with dual TRK/ALK inhibitors
and to drive deep, durable responses for patients across all lines
of therapy. NVL-655 has received orphan drug designation for
ALK-positive non-small cell lung cancer (NSCLC) and is currently
being investigated in the ALKOVE-1 clinical trial (NCT05384626), a
first-in-human Phase 1/2 clinical trial for patients with advanced
ALK-positive NSCLC and other solid tumors.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a
clinical-stage biopharmaceutical company focused on creating
precisely targeted therapies for patients with cancer,
designed to overcome the limitations of existing therapies for
clinically proven kinase targets. Leveraging deep expertise in
chemistry and structure-based drug design, we develop innovative
small molecules that have the potential to overcome resistance,
minimize adverse events, address brain metastases, and drive more
durable responses. Nuvalent is advancing a robust pipeline with
investigational candidates for ROS1-positive, ALK-positive, and
HER2-altered non-small cell lung cancer, and multiple
discovery-stage research programs.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding Nuvalent's strategy, business plans,
and focus; the expected timing of data announcements; the potential
benefits and effects of Nuvalent's product development candidates;
the potential of Nuvalent's pipeline programs, including
zidesamtinib and NVL-655; the implications of data readouts and
presentations; Nuvalent's research and development programs for the
treatment of cancer; and risks and uncertainties associated with
drug development. The words "may," "might," "will," "could,"
"would," "should," "expect," "plan," "anticipate," "aim," "goal,"
"intend," "believe," "expect," "estimate," "seek," "predict,"
"future," "project," "potential," "continue," "target" or the
negative of these terms and similar words or expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. You should not place undue
reliance on these statements or the scientific data presented.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties, and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation: risks that
Nuvalent may not fully enroll the ARROS-1 or ALKOVE-1 trials or
that enrollment will take longer than expected; unexpected concerns
that may arise from additional data, analysis, or results obtained
during preclinical studies or clinical trials; the risk that
results of earlier clinical trials may not be predictive of the
results of later-stage clinical trials; the risk that data from our
clinical trials may not be sufficient to support registration and
that Nuvalent may be required to conduct one or more additional
studies or trials prior to seeking registration of our product
candidates; risks that Nuvalent may not achieve the goals and
milestones set forth in its OnTarget 2026 operating plan; the
occurrence of adverse safety events; risks that the FDA may not
approve our potential products on the timelines we expect, or at
all; risks of unexpected costs, delays, or other unexpected
hurdles; risks that Nuvalent may not be able to nominate drug
candidates from its discovery programs; the direct or indirect
impact of public health emergencies or global geopolitical
circumstances on the timing and anticipated timing and results of
Nuvalent's clinical trials, strategy, and future operations,
including the ARROS-1 and ALKOVE-1 trials; the timing and outcome
of Nuvalent's planned interactions with regulatory authorities; and
risks related to obtaining, maintaining, and protecting Nuvalent's
intellectual property. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in Nuvalent's Quarterly Report on Form 10-Q for the quarterly
period ended March 31, 2024, as well
as any prior and subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Nuvalent's views only as of today and should not be
relied upon as representing its views as of any subsequent date.
Nuvalent explicitly disclaims any obligation to update any
forward-looking statements.
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SOURCE Nuvalent, Inc.