Company plans to host a conference call on
October 13, 2023
CAMBRIDGE, Mass., Sept. 18,
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 it will
present preliminary dose-escalation data from its ongoing ALKOVE-1
Phase 1/2 clinical trial of NVL-655 at the 35th
AACR-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts.
The presentation marks the first disclosure of data
characterizing the safety and clinical activity of NVL-655 from the
Phase 1 dose-escalation portion of the ongoing ALKOVE-1 Phase 1/2
clinical trial evaluating NVL-655 in patients with advanced
ALK-positive non-small cell lung cancer (NSCLC) and other solid
tumors. NVL-655 has been designed with the aim to address
challenges that limit clinical use of existing ALK tyrosine kinase
inhibitors (TKIs), including treatment emergent resistance
mutations, lack of brain penetrance, and off-target CNS adverse
events. The ALKOVE-1 clinical trial is continuing to enroll
patients in the Phase 1 portion of the trial.
Nuvalent plans to host a conference call and webcast on
October 13, 2023. Details for the
conference call will be provided at a future date and available on
the Nuvalent website at www.nuvalent.com.
Details for the presentation are as follows:
Title: Safety and preliminary activity of the selective
ALK inhibitor NVL-655 in patients with ALK fusion-positive solid
tumors
Abstract Number: 35177
Poster Number: B154
Session: Poster Session B
Session Date and Time: Friday,
October 13, 12:30 pm-4:00
pm
Presenting Author: Jessica J Lin, Massachusetts General
Hospital (MGH), Boston, MA
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 clinical trial (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 expected timing of data announcements; the
preclinical and clinical development programs for NVL-655; the
potential clinical effect of NVL-655; the design and enrollment of
the ALKOVE-1 clinical trial; the potential of NVL-655; 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 ALKOVE-1 clinical trial 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, including ALKOVE-1;
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 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 ALKOVE-1 clinical trial; 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 the Company's Quarterly Report on Form
10-Q for the quarterly period ended June 30,
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.