ArQule to Host Analyst Call Highlighting Clinical Progress from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies

From Startup ARQULE

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BURLINGTON, Mass.–(BUSINESS WIRE)–Nov. 29, 2018–
ArQule, Inc. (Nasdaq: ARQL) today announced that it will host a call to
discuss the updated safety, PK, biomarker and anti-tumor activity data
from the company’s Phase 1 dose escalation study in patients with
relapsed or refractory hematologic malignancies (ARQ 531-101) that are
being presented in a poster presentation at the 60thAmerican
Society of Hematology (ASH) Annual Meeting and Exposition on December 3,
2018 in San Diego.

Call Details
Date: Monday, December 3, 2018Time:6:00 a.m.
PT/9:00 a.m. ET

The live webcast can be accessed in the “Investors and Media” section of
our website,,
under “Events & Presentations.” You may also listen to the call by
dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the
U.S. A replay will be available two hours after the completion of the
call and can be accessed in the “Investors & Media” section of our
under “Events and Presentations.”

About BTK and ARQ 531Bruton’s tyrosine kinase, BTK, is a
therapeutic target that has been clinically proven to inhibit B-cell
receptor signaling in blood cancers. ARQ 531 is an orally bioavailable,
potent and reversible BTK inhibitor. Biochemical and cellular studies
have shown that ARQ 531 inhibits both the wild type and C481S-mutant
forms of BTK. The C481S-mutation is a known resistance mechanism for
first generation irreversible BTK inhibitors. In preclinical studies,
ARQ 531 has demonstrated good oral bioavailability as well as favorable
pharmacokinetic, pharmacodynamic and metabolic properties.

About ArQuleArQule is a biopharmaceutical company engaged
in the research and development of targeted therapeutics to treat
cancers and rare diseases. ArQule’s mission is to discover, develop and
commercialize novel small molecule drugs in areas of high unmet need
that will dramatically extend and improve the lives of our patients. Our
clinical-stage pipeline consists of five drug candidates, all of which
are in targeted, biomarker-defined patient populations, making ArQule a
leader among companies our size in precision medicine. ArQule’s pipeline
includes: ARQ 531, an orally bioavailable, potent and reversible
inhibitor of both wild type and C481S-mutant BTK, in Phase 1 for
patients with B-cell malignancies refractory to other therapeutic
options; miransertib (ARQ 092), a selective inhibitor of the AKT
serine/threonine kinase, in a Phase 1/2 company-sponsored study for
Overgrowth Diseases, in a Phase 1 study for ultra-rare Proteus syndrome
conducted by the National Institutes of Health (NIH), and in Phase 1b in
combination with the hormonal therapy, anastrozole, in patients with
advanced endometrial cancer; ARQ 751, a next generation AKT inhibitor,
in Phase 1 for patients with AKT1 and PI3K mutations; derazantinib, a
multi-kinase inhibitor designed to preferentially inhibit the fibroblast
growth factor receptor (FGFR) family, in a registrational trial for
iCCA; and ARQ 761, a β-lapachone analog being evaluated as a promoter of
NQO1-mediated programmed cancer cell necrosis, in Phase 1/2 in multiple
oncology indications in partnership with the University of Texas
Southwestern Medical Center. ArQule’s current discovery efforts are
focused on the identification and development of novel kinase
inhibitors, leveraging the Company’s proprietary library of compounds.

Forward-Looking StatementsThis press release contains
forward-looking statements, including without limitation those regarding
the current clinical trial with ARQ 531. These statements are based on
the Company’s current beliefs and expectations, and are subject to risks
and uncertainties that could cause actual results to differ materially
from those set forth in this press release. Positive information about
early stage clinical trial results does not ensure that later stage or
larger scale clinical trials will be successful. For example, ARQ 531
may not demonstrate promising therapeutic effect; in addition, it may
not demonstrate an appropriate safety profile in current or later stage
or larger scale clinical trials as a result of known or as yet
unanticipated side effects. The results achieved in later stage trials
may not be sufficient to meet applicable regulatory standards or to
justify further development. Problems or delays may arise prior to the
initiation of planned clinical trials, during clinical trials or in the
course of developing, testing or manufacturing that could lead the
Company to discontinue development. Even if later stage clinical trials
are successful, unexpected concerns may arise from subsequent analysis
of data or from additional data. Obstacles may arise or issues may be
identified in connection with review of clinical data with regulatory
authorities. Regulatory authorities may disagree with the Company’s or
its collaborators’ view of data or require additional data or
information or additional studies. In addition, the planned timing of
completion of clinical trials is subject to the ability of the Company
and, in certain cases, its collaborators to enroll patients, enter into
agreements with clinical trial sites and investigators, and overcome
technical hurdles and other issues related to the conduct of the trials
for which each of them is responsible. There is a risk that these issues
may not be successfully resolved. In addition, we expect to utilize
diagnostic tools in ongoing and future biomarker-guided clinical trials
with ARQ 531. We or our collaborators may encounter difficulties in
developing and obtaining approval for companion diagnostics, including
issues relating to access to certain technologies,
selectivity/specificity, analytical validation, reproducibility, or
clinical validation. Any delay or failure by our collaborators or us to
develop or obtain regulatory approval of companion diagnostics could
delay or prevent approval of our product candidates. Only a small number
of research and development programs result in the commercialization of
a product. Furthermore, ArQule may not have the financial or human
resources to successfully pursue drug discovery in the future. For more
detailed information on the risks and uncertainties associated with the
Company’s drug development, financial condition and other activities,
see the Company’s periodic reports filed with the Securities and
Exchange Commission. The Company does not undertake any obligation to
publicly update any forward-looking statements.

View source version on
Source: ArQule, Inc.
Corporate Contact:Marc Schegerin, M.D.Senior Vice
PresidentHead of Strategy, Finance and
Media Contact:Allison Blum, Ph.D.LifeSci Public
Relations (646)

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2018-11-30 05:29:51