CAMBRIDGE, Mass., July 22, 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 the initiation of
HEROEX-1, its Phase 1a/1b clinical
trial evaluating its novel HER2-selective inhibitor, NVL-330, for
pre-treated patients with HER2-altered non-small cell lung cancer
(NSCLC).
"HER2 alterations are an important category of oncogenic drivers
within NSCLC that includes both HER2 amplification and HER2
mutations, the majority of which are exon 20 mutations. While HER2-
targeted therapies have been developed, there are currently no
approved TKIs for the HER2-mutant NSCLC patient population,"
said Christopher Turner, M.D.,
Chief Medical Officer of Nuvalent. "At the outset of our
program, physician-scientists outlined the need for a HER2 therapy
that maintained activity against HER2 exon 20 mutations, was
selective for HER2 versus wild-type EGFR to limit gastrointestinal
and skin toxicities associated with EGFR inhibition, and was brain
penetrant to address and limit brain metastases. NVL-330's
preclinical profile has demonstrated the potential to be
differentiated through combining these desired characteristics, and
supports its initial clinical investigation in our HEROEX-1 trial
for patients with HER2-altered NSCLC."
HEROEX-1 is a Phase 1a/1b,
multicenter, open-label, dose-escalation and expansion trial
evaluating NVL-330 in pre-treated patients with advanced
HER2-altered NSCLC, including those with HER2 exon 20 mutations.
The trial will evaluate the overall safety and tolerability of
NVL-330. Additional objectives include determination of the
recommended Phase 2 dose (RP2D), characterization of the
pharmacokinetic profile, and preliminary evaluation of anti-tumor
activity.
"The initiation of this trial represents a significant milestone
for Nuvalent, marking the third program from our novel pipeline to
enter clinical development in under three years," said
James Porter, Ph.D., Chief Executive
Officer at Nuvalent. "This rapid execution serves as a
testament to our team's dedication to rapid progress and growth
across our pipeline, and our unwavering commitment to our goal of
bringing precisely targeted therapies to patients with
cancer."
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-altered 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. NVL-330 is currently being investigated
in the HEROEX-1 Phase 1a/1b clinical
trial for pre-treated patients with advanced HER2-altered
NSCLC.
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 clinical development program for NVL-330; the
potential clinical effect of NVL-330; the design of the HEROEX-1
trial; the potential of Nuvalent's pipeline programs, including
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
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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 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.