Preliminary dose-escalation data anticipated
in second half of 2022 for ongoing ARROS-1 Phase 1/2 clinical trial
of NVL-520 for patients with advanced ROS1-positive NSCLC and other
solid tumors
First patient dosed in ALKOVE-1 Phase 1/2
clinical trial of NVL-655 for patients with advanced ALK-positive
NSCLC and other solid tumors
CAMBRIDGE, Mass., June 21,
2022 /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 progress on its parallel lead
clinical programs NVL-520, a novel ROS1-selective inhibitor, and
NVL-655, a novel ALK-selective inhibitor. Nuvalent announced that
it plans to share preliminary data from the dose-escalation portion
of its ongoing ARROS-1 Phase 1/2 clinical trial for NVL-520 in
patients with advanced ROS1-positive NSCLC and other solid tumors
in the second half of 2022. In addition, Nuvalent announced that
the first patient has been dosed in ALKOVE-1, its 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-520 and NVL-655 have been designed to address the
clinical challenges of emergent treatment resistance, off-target
CNS adverse events, and brain metastases that may limit the use of
currently available ROS1 and ALK kinase inhibitors.
"Advancing two novel candidates into clinical development in a
little over six months is a significant achievement that we believe
demonstrates our ability to scale as a clinical stage company with
our growing portfolio, and the value of continued collaboration
with leading physician-scientists in the advancement of
investigational opportunities for patients in need of new
therapies," said Christopher Turner,
M.D., Chief Medical Officer of Nuvalent. "We remain committed
to the efficient and data-driven development of NVL-520 and NVL-655
through our ARROS-1 and ALKOVE-1 studies and look forward to the
opportunity to share preliminary data from the dose-escalation
portion of the ARROS-1 trial later this year."
ARROS-1 is a Phase 1/2, multicenter, open-label, dose-escalation
and expansion trial evaluating NVL-520 in patients with advanced
ROS1-positive NSCLC and other solid tumors. ARROS-1 is actively
enrolling patients with previously treated ROS1-positive solid
tumors in the Phase 1 portion of the study. Additional information
on the ARROS-1 trial is available on www.ClinicalTrials.gov
(NCT05118789).
ALKOVE-1 is a Phase 1/2, multicenter, open-label,
dose-escalation and expansion trial evaluating NVL-655 in patients
with advanced ALK-positive NSCLC and other solid tumors. The Phase
1 dose-escalation portion of the study is open and enrolling
patients with previously treated ALK-positive solid tumors and will
evaluate the overall safety and tolerability of NVL-655. Additional
objectives include determination of the recommended Phase 2 dose
(RP2D), characterization of the pharmacokinetic profile, and
evaluation of preliminary anti-tumor activity.
Once a safe and tolerable dose is determined as the RP2D, the
ALKOVE-1 trial is designed to transition directly into the Phase 2
multiple cohort expansion portion, which will evaluate the overall
activity of NVL-655 in patients with advanced ALK-positive NSCLC
and other 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 with the intent to expand in size, as data emerge and in
collaboration with the U.S. Food and Drug Administration (FDA),
into potential registrational cohorts for the treatment of
previously treated patients with ALK-positive NSCLC. Additional
information on the ALKOVE-1 trial is available on
www.ClinicalTrials.gov (NCT05384626).
"The ALKOVE-1 study has been designed with the goal of
seamlessly accelerating from first-in-human dose-exploration of
NVL-655 into Phase 2 cohorts evaluating a range of ALK-positive
patient populations," said Darlene
Noci, A.L.M., Senior Vice President of Product Development
& Regulatory Affairs for Nuvalent. "We believe the growing body
of preclinical data generated to date for NVL-655 continue to
demonstrate its promise as a differentiated ALK-selective inhibitor
with the potential to overcome the limitations of currently
available therapies, and are supportive of its development
throughout the treatment paradigm for patients with ALK-positive
cancers."
In addition to NVL-520 and NVL-655, Nuvalent continues to
advance its pipeline expansion efforts with multiple
discovery-stage research programs.
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 wild-type ROS1 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/ROS1 inhibitors and drive more
durable responses for patients. NVL-520 is currently being
investigated in the ARROS-1 study (NCT05118789), a first-in-human
Phase 1/2 clinical trial for patients with advanced non-small cell
lung cancer (NSCLC) and other solid tumors.
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), 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 programs for NVL-520 and
NVL-655 and the timing thereof; the potential clinical effect of
NVL-520 and NVL-655; the design and enrollment of the ARROS-1 and
ALKOVE-1 studies 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;
and capital allocation. 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 ARROS-1 or ALKOVE-1 studies or
that enrollment will take longer than expected; unexpected concerns
that may arise from additional data, analysis, or results obtained
during 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 HER2 Exon 20 and ALK IXDN 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
ARROS-1 and ALKOVE-1 studies; 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 Annual Report
on Form 10-K for the year ended December 31, 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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