CAMBRIDGE, Mass., March 5, 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
upcoming preclinical data poster presentations further
characterizing the preclinical profiles of its novel HER2-selective
inhibitor, NVL-330, and novel ROS1-selective inhibitor,
zidesamtinib (NVL-520), at the American Association for Cancer
Research (AACR) Annual Meeting 2024 from April 5 – 10 in San
Diego.
Details of the poster presentations are as follows:
Title: Preclinical characterization of NVL-330, a
selective and brain penetrant HER2 tyrosine kinase inhibitor with
broad activity on HER2 oncogenic alterations
Authors: Yuting Sun*1, Kristin L. Andrews1, Anupong
Tangpeerachaikul1, Tuan M.
Nguyen1, Baudouin
Gerard1, Nancy E.
Kohl2, Joshua C.
Horan1, Henry E.
Pelish1
Abstract Number: 1979
Session Category: Experimental and Molecular
Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 2
Session Date and Time: Monday April 8, 2024, from 9:00
– 12:30 p.m. PT
Location: Poster Section 25
Title: Mutagenesis screens support potential
best-in-class profile for selective, brain-penetrant, and
TRK-sparing ROS1 inhibitor zidesamtinib (NVL-520)
Authors: Anupong Tangpeerachaikul*1,
Franklin Gu1,
Henry E.
Pelish1
Abstract Number: LB182
Session Title: Late-Breaking Research: Experimental and
Molecular Therapies 2
Session Date and Time: Monday April 8, 2024, from 1:30
– 5:00 p.m. PT
Location: Poster Section 52
*Presenter, corresponding author; 1Nuvalent, Inc.,
Cambridge, MA, USA;
2Kohl Consulting, Wellesley,
MA, USA
Posters will be archived on the Nuvalent website
at www.nuvalent.com.
About NVL-330
NVL-330 is a novel brain-penetrant
HER2-selective tyrosine kinase inhibitor designed to address the
combined medical need of treating HER2-mutant tumors, including
those with HER2 exon 20 insertion mutations, avoiding treatment
related adverse events due to off-target inhibition of wild-type
EGFR, and treating brain metastases.
About zidesamtinib (NVL-520)
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 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-positive
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 development programs for zidesamtinib
(NVL-520) and NVL-330; the potential benefits of zidesamtinib and
NVL-330; the potential of Nuvalent's pipeline programs, including
zidesamtinib and NVL-330; 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: 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; 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; 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 Annual Report
on Form 10-K for the fiscal year ended December 31, 2023, 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.