ArQule to Present Clinical & Preclinical Data for ARQ 751 at the 30th EORTC/AACR/NCI Symposium

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Link to Full Article: http://investors.arqule.com/news-releases/news-release-details/arqule-present-clinical-and-preclinical-data-arq-751-30th

Three poster presentations highlighting clinical data from ARQ
751-101 and preclinical data on ARQ 751 in combination with other agents
BURLINGTON, Mass.–(BUSINESS WIRE)–Nov. 8, 2018–
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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005099/en/
Source: ArQule, Inc.
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

Please visit their site for more information: ARQULE.com
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2018-11-09 05:30:32