ArQule to Present Clinical and Preclinical Data for ARQ 751 at the 30th EORTC/AACR/NCI Symposium
November 08 2018 - 07:00AM
Business Wire
Three poster presentations highlighting
clinical data from ARQ 751-101 and preclinical data on ARQ 751 in
combination with other agents
ArQule, Inc. (Nasdaq: ARQL) today announced that it will be
presenting clinical and preclinical data on the company’s next
generation AKT inhibitor, ARQ 751, in three poster presentations at
the 30th EORTC/AACR/NCI Symposium to be held from November 13 to
16, 2018 in Dublin, Ireland.
Presentation
Details
Title:
A Phase 1 Dose Escalation Study of ARQ 751 in Adult
Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic
Alterations, Activating PI3K Mutations, PTEN-null, or Other Known
Actionable PTEN Mutations
Abstract #:
395
Session:
Molecular Targeted Agents - PART II
Date:
Friday, November 16, 2018
Time:
10:00-14:00 PM CET
Location:
Exhibition Hall
Title:
Combination of the AKT inhibitor ARQ 751 with Immune Checkpoint
Inhibitor and Other Therapeutic Agents
Abstract #:
371
Session:
Molecular Targeted Agents - PART II
Date:
Friday, November 16, 2018
Time:
10:00-14:00 PM CET
Location:
Exhibition Hall
Title:
Miransertib and ARQ 751 exhibit superior cell-death-inducing
properties compared to other AKT inhibitors and can overcome
resistance to other allosteric AKT inhibitors
Abstract #:
442
Session:
Molecular Targeted Agents - PART II
Date:
Friday, November 16, 2018
Time:
10:00-14:00 PM CET
Location:
Exhibition Hall
About ARQ 751ARQ 751 is an orally bioavailable, selective
small molecule inhibitor of the AKT serine/threonine kinase. The
AKT pathway when abnormally activated is implicated in multiple
oncogenic processes such as cell proliferation and apoptosis. This
pathway has emerged as a target of potential therapeutic relevance
for compounds that inhibit its activity, which has been linked to a
variety of cancers as well as to select non-oncology indications.
ARQ 751 is currently in a Phase 1 study in adult patients with
refractory and/or metastatic tumors that harbor genetic alterations
along the AKT pathway.
About MiransertibMiransertib (ARQ 092) is an orally
available, selective, pan-AKT (protein kinase B) inhibitor that
potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has
been implicated in a variety of rare overgrowth diseases and
cancers; however, there are currently no approved inhibitors of
AKT. AKT inhibitors, either as single agent or combination therapy,
show significant promise in molecularly defined patient
populations. Miransertib is currently in a Phase 1/2
company-sponsored study for PIK3CA-Related Overgrowth Spectrum
(PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted
by the National Institutes of Health (NIH/NHGRI), and a Phase 1b
study in combination with the hormonal therapy, anastrozole, in
patients with advanced endometrial cancer with AKT and PI3K
mutations. Miransertib has been granted Rare Pediatric Disease
Designation and Fast Track Designation by the U.S. Food and Drug
Administration (FDA), as well as Orphan Designation by the FDA and
European Medicines Agency in the rare overgrowth disease, Proteus
syndrome.
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 regarding the planned clinical
development of miransertib and ARQ 751. 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. Positive information about early clinical
results does not ensure that later-stage clinical trials will be
successful. For example, miransertib and ARQ 751 may not
demonstrate sufficient therapeutic effect in man; in addition,
neither drug candidate may exhibit an adequate safety profile in
planned 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 during clinical trials or in the course of
developing, testing or manufacturing miransertib and ARQ 751 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 view of the data or require
additional data or information or additional studies. In addition,
we are utilizing diagnostic tests to identify patients in the Phase
1/2 trial with miransertib in PROS diseases and in the Phase 1
trial with ARQ 751 in patients with AKT and PI3K mutations. We
expect to utilize diagnostic tests in other clinical trials with
miransertib and ARQ 751. We or our collaborators may need to
develop and register these or other diagnostic tests as companion
diagnostics with the FDA. We or our collaborators may
encounter difficulties in developing and obtaining regulatory
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. Drug development involves a high
degree of risk. Only a small number of research and development
programs result in the commercialization of a product. For more
detailed information on the risks and uncertainties associated with
the Company's drug development 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181108005099/en/
Corporate Contact:ArQule, Inc.Marc Schegerin, M.D.Senior
Vice President, Head of Strategy, Finance and
Communicationir@arqule.comwww.ArQule.comorMedia
Contact:LifeSci Public RelationsAllison Blum, Ph.D.,
646-627-8383Allison@lifescipublicrelations.com
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