CAMBRIDGE, Mass., March 14,
2023 /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 an
upcoming preclinical data poster presentation supporting the
ongoing clinical development of its ALK-selective inhibitor,
NVL-655. The data, resulting from a collaboration with the
Yonsei University College of Medicine,
will be presented at the American Association for Cancer Research
(AACR) Annual Meeting 2023, taking place April 14-19 in Orlando,
Florida.
The poster describes the preclinical intracranial antitumor
activity of NVL-655 in a brain-implanted xenograft model derived
from a patient with lung cancer harboring the alectinib-resistant
EML4-ALK v3 G1202R mutation. The poster additionally expands the
characterization of NVL-655 alongside other ALK inhibitors. NVL-655
has previously demonstrated intracranial efficacy in a cell
line-derived xenograft model as well as broad preclinical activity
across diverse ALK resistance mutations and tumor types while
maintaining high selectivity for ALK over TRKB. NVL-655 is
currently being investigated in the ALKOVE-1 study (NCT05384626), a
first-in-human Phase 1/2 clinical trial for patients with advanced
ALK-positive non-small cell lung cancer (NSCLC) and other solid
tumors.
The poster will be archived on the Nuvalent website at
www.nuvalent.com following the presentation.
Details for the poster presentation are as follows:
Title: Preclinical intracranial
activity of NVL-655 in an alectinib-resistant patient-derived model
harboring EML4-ALK fusion with G1202R
mutation
Authors: Jii
Bum Lee*1, Mi Ra
Yu*1, Mi Ran
Yun1, You Won Lee1, Seung Yeon Oh1, Eun Ji Lee1, Anupong
Tangpeerachaikul2, Henry E.
Pelish2, Byoung Chul
Cho1
Presenter: Anupong
Tangpeerachaikul, Ph.D.
Permanent
Abstract: 4022
Session Category: Experimental and Molecular
Therapeutics
Session Title: Tyrosine Kinase and Phosphatase
Inhibitors 1
Session Date and Time: Tuesday
April 18, 2023 from 9:00
a.m. – 12:30 p.m. ET
Location: Orange
County Convention Center, Poster Section
20
1Yonsei University College of Medicine, Seoul, Republic of Korea 2Nuvalent
Inc., Cambridge, MA,
USA
*Equal contributions
About NVL-655
NVL-655 is a novel brain-penetrant ALK-selective inhibitor
created 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 the solvent front G1202R
mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R /
G1269A ("GRGA"), or G1202R / L1198F ("GRLF"). NVL-655 has been
optimized for CNS penetrance to improve treatment options for
patients with brain metastases. NVL-655 has been observed in
preclinical studies to selectively inhibit wild-type ALK and its
resistance variants over the structurally related tropomyosin
receptor kinase (TRK) family to potentially avoid TRK-related CNS
adverse events seen with dual TRK/ALK inhibitors and drive more
durable responses for patients. NVL-655 is currently being
investigated in the ALKOVE-1 study (NCT05384626), a first-in-human
Phase 1/2 clinical trial for patients with advanced ALK-positive
non-small cell lung cancer (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 parallel lead programs in ROS1-positive and
ALK-positive non-small cell lung cancer (NSCLC), a program in HER2
Exon 20 insertion-positive cancers, and multiple discovery-stage
research programs. We routinely post information that may be
important to investors on our website
at www.nuvalent.com. Follow us on Twitter (@nuvalent)
and LinkedIn.
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 preclinical and clinical development programs for
NVL-655; the potential clinical effect of NVL-655; the design and
enrollment of the ALKOVE-1 study; the potential of Nuvalent's
pipeline programs, including NVL-655; Nuvalent's research and
development programs for the treatment of cancer; and risks and
uncertainties associated with drug development. The words "may,"
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"anticipate," "aim," "goal," "intend," "believe," "expect,"
"estimate," "seek," "predict," "future," "project," "potential,"
"continue," "target" or the negative of these terms and similar
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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 ALKOVE-1 study 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 occurrence of adverse
safety events; 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 COVID-19 or other global geopolitical circumstances on
the timing and anticipated timing and results of Nuvalent's
clinical trials, strategy, and future operations, including the
ALKOVE-1 study; the timing and outcome of Nuvalent's planned
interactions with regulatory authorities; and obtaining,
maintaining, and protecting its intellectual property. These and
other risks and uncertainties are described in greater detail in
the section entitled "Risk Factors" in the Company's Quarterly
Report on Form 10-Q for the quarterly period ended September 30, 2022, 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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