ARIAD Announces FDA Clearance to Begin Clinical Development of AP32788
February 01 2016 - 7:35AM
Business Wire
Internally Discovered Product Candidate
Designed to Address Unmet Need in Non-Small Cell Lung Cancer
Patients with Specific EGFR and HER2 Kinase Mutations
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that
the U.S. Food and Drug Administration (FDA) has completed its
review of the Company’s Investigational New Drug (IND) application
for AP32788, a tyrosine kinase inhibitor (TKI) designed as a
targeted therapy for patients with non-small cell lung cancer
(NSCLC) with specific mutations in EGFR or HER2. ARIAD anticipates
initiation of its Phase 1/2 clinical trial of AP32788 in patients
with NSCLC in the second quarter of 2016.
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AP32788 (gray) shown binding to EGFR
(Photo: Business Wire)
AP32788 targets tumors driven by EGFR or HER2 kinases and was
designed to achieve selective inhibition of exon 20 insertion
mutations in these kinases. In preclinical studies, AP32788
potently inhibited EGFR mutations including exon 20 mutations,
while remaining selective over native EGFR. It was also active
against HER2 activating mutations including exon 20 mutations.
“ARIAD scientists designed AP32788 using our integrated drug
discovery program to target cancer orphan subsets that are
genetically defined but have no current targeted treatment options.
This compound specifically addresses the needs of patients with
NSCLC driven by EGFR exon 20 or HER2 mutations, who currently have
a poor prognosis and limited treatment options,” stated Timothy P.
Clackson, president of research and development and chief
scientific officer of ARIAD. “Data on the preclinical
characterization of AP32788 have been submitted for presentation at
the American Association of Cancer Research annual meeting in
April.”
EGFR mutations represent the largest known, targetable subset of
NSCLC. While the most common types of EGFR mutation are addressed
by approved TKI therapies, there are no targeted treatment options
available for the approximately 4 to 9 percent of EGFR-mutated lung
tumors with exon 20 insertion mutations.1 In addition, patients
with HER2 mutations, mostly exon 20 insertion mutations, comprise
approximately 2 percent of NSCLC patients2 and also have no current
targeted treatment options. ARIAD estimates that there are
approximately 6,000 patients in the United States living with EGFR
exon 20 or HER2 point mutations, based on a broader data set of
175,000 patients with stage IIIb or IV NSCLC living in the U.S. in
2015, according to Kantar Health.
About AP32788
AP32788 is an investigational oral tyrosine kinase inhibitor
(TKI) of activating mutations in EGFR and HER2. The molecule was
designed to address the unmet need in patients with non-small cell
lung cancer (NSCLC) driven by exon 20 insertion mutations in EGFR
and HER2, and is ARIAD’s fourth internally discovered oncology IND
to be cleared for clinical development.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to, statements concerning the
intended therapeutic targets of AP32788, the start of our Phase 1/2
clinical trial, the presentation of pre-clinical data, and the
potential addressable patient population for AP32788, are
forward-looking statements that are based on management’s
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such forward-looking statements. These factors, risks
and uncertainties include, but are not limited to, our ability to
successfully commercialize and generate profits from sales of
Iclusig and our product candidates, if approved; competition from
alternative therapies; our ability to meet anticipated clinical
trial commencement, enrollment and completion dates and regulatory
filing dates for our products and product candidates and to move
new development candidates into the clinic; our ability to execute
on our key corporate initiatives; regulatory developments and
safety issues, including difficulties or delays in obtaining
regulatory and pricing and reimbursement approvals to market our
products; our reliance on the performance of third-party
manufacturers and specialty pharmacies for the supply and
distribution of our products and product candidates; the occurrence
of adverse safety events with our products and product candidates;
the costs associated with our research, development, manufacturing,
commercialization and other activities; the conduct, timing and
results of preclinical and clinical studies of our products and
product candidates, including that preclinical data and early-stage
clinical data may not be replicated in later-stage clinical
studies; the adequacy of our capital resources and the availability
of additional funding; the ability to satisfy our contractual
obligations, including under our leases, convertible debt and
royalty financing agreements; patent protection and third-party
intellectual property claims; litigation; our operations in foreign
countries; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and
other risk factors detailed in our public filings with
the U.S. Securities and Exchange Commission, including our
most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release.
1 Costa, D. 2015. EGFR Exon 20 Insertion in Non-Small Cell Lung
Cancer. My Cancer Genome
http://www.mycancergenome.org/content/disease/lung-cancer/egfr/64/
(Updated November 5, 2015).
2 JCO April 22, 2013 JCO.2012.45.6095
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version on businesswire.com: http://www.businesswire.com/news/home/20160201005270/en/
For InvestorsMaria Cantor,
617-621-2208Maria.cantor@ariad.comorFor MediaLiza Heapes,
617-620-4888Liza.heapes@ariad.com
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