CAMBRIDGE, Mass., Jan. 7, 2022 /PRNewswire/ -- Nuvalent, Inc.
(Nasdaq: NUVL), a biotechnology company creating
precisely targeted therapies for clinically proven
kinase targets in cancer, today announced that the first patient
has been dosed in ARROS-1, its Phase 1/2 clinical trial evaluating
NVL-520 in patients with advanced ROS1-positive non-small cell lung
cancer (NSCLC) and other advanced solid tumors. NVL-520, Nuvalent's
lead product candidate, is a novel ROS1-selective inhibitor
designed to address the clinical challenges of emergent treatment
resistance, CNS adverse events, and brain metastases that may limit
the use of currently available ROS1 kinase inhibitors.
"The initiation of patient dosing with NVL-520 in ARROS-1 is a
significant milestone for Nuvalent as we transition from a
preclinical to clinical stage company," said Christopher Turner, M.D., Chief Medical Officer
of Nuvalent. "We designed NVL-520 with the goal of fulfilling a
specific target product profile developed in collaboration with
leading physician-scientists who are actively treating patients
with ROS1-driven cancers today. We are encouraged by the
preclinical data generated to date, which provide evidence that
NVL-520 represents a differentiated ROS1-selective inhibitor with
the potential to overcome the limitations of current tyrosine
kinase inhibitor therapies and provide a new therapeutic option for
patients in need."
ARROS-1 is a Phase 1/2, multicenter, open-label, dose-escalation
and expansion trial evaluating NVL-520 as an oral monotherapy. The
Phase 1 dose-escalation portion of the study is open and enrolling
patients with advanced ROS1-positive solid tumors who have been
previously treated with at least one prior ROS1 tyrosine kinase
inhibitor (TKI) therapy, and will evaluate the overall safety and
tolerability of NVL-520 as well as determine the recommended Phase
2 dose (RP2D), characterize the pharmacokinetic profile, and
evaluate preliminary anti-tumor activity.
Once a safe and tolerable dose is determined as the RP2D, the
trial is designed to transition directly into the Phase 2 multiple
cohort expansion portion, which will evaluate the overall activity
of NVL-520 in patients with advanced ROS1-positive NSCLC and other
advanced solid tumors. The Phase 2 portion will examine several
cohorts of patients based on the number and type of prior
anti-cancer therapies they have received. The Phase 2 cohorts are
designed to support potential registration in ROS1-positive
patients with NSCLC who are kinase inhibitor-naïve and in those who
have been previously treated with ROS1 kinase inhibitors.
"Nuvalent thoughtfully designed the ARROS-1 trial to support the
goal of seamless acceleration from first-in-human dose-exploration
of NVL-520 into Phase 2 cohorts that are structured to evaluate
multiple opportunities for potential registration," said
Darlene Noci, A.L.M., Senior Vice
President of Product Development & Regulatory Affairs for
Nuvalent. "Through parallel evaluation of NVL-520 in TKI-naïve and
clearly defined cohorts of pre-treated patients, we aim to generate
data to comprehensively evaluate NVL-520 throughout the treatment
paradigm for ROS1-driven cancers."
In addition to NVL-520, Nuvalent is advancing a robust pipeline
including the development of NVL-655 as a parallel lead program for
the potential treatment of patients with ALK-positive NSCLC, along
with multiple discovery-stage research programs.
"Our focus in 2022 is on establishing Nuvalent as an
operationally efficient, clinical-stage biotech company with an
active in-house R&D pipeline. We are on track for the planned
IND submission for NVL-655 which we expect to enable the opening of
our second Phase 1/2 clinical trial for enrollment in the first
half of the year, and continue to plan for portfolio expansion with
multiple internally discovered novel drug candidates," said
James Porter, Ph.D., Chief Executive
Officer at Nuvalent. "Through the prioritization of a pipeline of
novel small molecules designed to overcome the dual challenges of
kinase resistance and selectivity, we aim to deliver new medicines
that may not only provide additional therapeutic options, but have
the potential to advance earlier in the treatment paradigm and
become best-in-class treatments for patients with cancer."
Nuvalent ended 2021 with $288.4
million in cash, cash equivalents and marketable securities
(unaudited), which, based on its current operating plans, is
expected to fund its operations into 2024.
About NVL-520
NVL-520 is a brain-penetrant ROS1-selective inhibitor designed
to remain active in tumors that have developed resistance to
currently available ROS1 inhibitors, including tumors with the
prevalent G2032R resistance mutation and those with the S1986Y/F,
L2026M, or D2033N resistance mutations. NVL-520 has been optimized
for brain penetrance to potentially improve treatment options for
patients with brain metastases. NVL-520 has been observed in
preclinical studies to selectively inhibit ROS1 over the
structurally related tropomyosin receptor kinase (TRK) family to
potentially avoid TRK-related CNS adverse events seen with dual
TRK/ROS1 inhibitors and drive more durable responses for patients
with ROS1-mutant variants. NVL-520 is currently being investigated
in the ARROS-1 study, a first-in-human Phase 1/2 clinical trial for
patients with advanced non-small cell lung cancer (NSCLC) and other
solid tumors.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a 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), along with
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 clinical development program for NVL-520 and NVL-655
and the timing thereof; the potential clinical effect of NVL-520;
the design and enrollment of the ARROS-1 study and the timing
thereof; the potential of Nuvalent's pipeline programs, including
NVL-520 and NVL-655; Nuvalent's research and development programs
for the treatment of cancer; risks and uncertainties associated
with drug development; capital allocation; and Nuvalent's future
financial and operating results and its expectations related
thereto. The words "may," "might," "will," "could," "would,"
"should," "expect," "plan," "anticipate," "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 study or it will take
longer than expected; unexpected concerns that may arise from
additional data, analysis, or results obtained during the ARROS-1
study; the occurrence of adverse safety events; risks of unexpected
costs, delays, or other unexpected hurdles; risks associated with:
the impact of COVID-19 on countries or regions in which Nuvalent
has operations or does business, as well as on the timing and
anticipated timing and results of its clinical trials, strategy,
and future operations, including the ARROS-1 study; the timing and
outcome of Nuvalent's planned interactions with regulatory
authorities; obtaining, maintaining, and protecting its
intellectual property; and potential changes in estimated cash,
cash equivalents, and marketable securities based on the completion
of financial closing procedures and release of complete fiscal 2021
results. 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 quarter ended
September 30, 2021, as well as any
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.