ArQule to Present Clinical and Preclinical Data for ARQ 751 at the 30th EORTC/AACR/NCI Symposium
Three poster presentations highlighting clinical data from ARQ 751-101 and preclinical data on ARQ 751 in combination with other agents
Presentation Details |
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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 751
ARQ 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 Miransertib
Miransertib (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
About
Forward Looking Statements
This 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005099/en/
Source:
Corporate Contact:
ArQule, Inc.
Marc Schegerin, M.D.
Senior
Vice President, Head of Strategy, Finance and Communication
ir@arqule.com
www.ArQule.com
or
Media
Contact:
LifeSci Public Relations
Allison Blum, Ph.D.,
646-627-8383
Allison@lifescipublicrelations.com