Checkpoint Therapeutics Receives Orphan Drug Designation for CK-101 for the Treatment of EGFR Mutation-Positive Non-Small Cel...
September 11 2017 - 8:30AM
Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ:CKPT), a
Fortress Biotech (NASDAQ:FBIO) company, today announced that the
U.S. Food and Drug Administration (FDA) has granted Orphan Drug
Designation to CK-101 (also known as RX518), the Company’s
third-generation epidermal growth-factor receptor (EGFR) inhibitor,
for the treatment of EGFR mutation-positive non-small cell lung
cancer (NSCLC).
CK-101 is currently being studied in the Phase 1
dose-escalation portion of a Phase 1/2 clinical study. The Phase 1
portion of the study is evaluating the safety and tolerability of
ascending doses of CK‐101 in patients with advanced solid tumors to
determine the maximum tolerated dose and / or recommended dose for
the Phase 2 portion of the study. The Phase 2 portion will evaluate
the safety and efficacy of CK-101 in patients with EGFR T790M
mutation-positive NSCLC.
“Securing Orphan Drug Designation is a
significant milestone that will support the clinical development of
our lead targeted therapy, CK-101, in EGFR mutation-positive
NSCLC,” said James F. Oliviero, President and Chief Executive
Officer of Checkpoint. “This Orphan Drug Designation builds upon
the issued U.S. composition of matter patent for CK-101, and could
provide the benefit of additional market exclusivity.”
Orphan Drug Designation is granted by the FDA to
drugs and biologics which are defined as those intended for the
safe and effective treatment, diagnosis or prevention of rare
diseases / disorders that affect fewer than 200,000 people in the
U.S. Orphan Drug Designation provides certain incentives that
may include tax credits toward the cost of clinical trials and
prescription drug user fee waivers. If a product holding Orphan
Drug Designation receives the first FDA approval for the disease in
which it has such designation, the product is entitled to seven
years of market exclusivity, which is independent from intellectual
property protection.
About Checkpoint
TherapeuticsCheckpoint Therapeutics, Inc. (“Checkpoint”)
is a clinical-stage, immuno-oncology biopharmaceutical company
focused on the acquisition, development and commercialization of
novel, non-chemotherapy, immune-enhanced combination treatments for
patients with solid tumor cancers. Checkpoint’s broad pipeline
consists of fully-human, immuno-oncology and checkpoint inhibitor
antibodies licensed from the Dana-Farber Cancer Institute that
target programmed death-ligand 1 (“PD-L1”); glucocorticoid-induced
TNFR-related protein (“GITR”); and carbonic anhydrase IX (“CAIX”).
In addition, Checkpoint is developing three oral, small-molecule,
targeted anti-cancer agents that inhibit epidermal growth-factor
receptor (“EGFR”) mutations, the bromodomain and extra-terminal
(“BET”) protein BRD4, and poly (ADP-ribose) polymerase (“PARP”).
Checkpoint will also seek to expand its pipeline to create
additional proprietary combination therapies that leverage the
immune system and complementary mechanisms. Checkpoint is
headquartered in New York City. For more information, visit
www.checkpointtx.com.
Checkpoint is a majority-controlled subsidiary
of Fortress Biotech, Inc.
About Fortress BiotechFortress
Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated
to acquiring, developing and commercializing novel pharmaceutical
and biotechnology products. Fortress develops and commercializes
products both within Fortress and through certain subsidiary
companies, also known as Fortress Companies. In addition to its
internal development programs, Fortress leverages its
biopharmaceutical business expertise and drug development
capabilities and provides funding and management services to help
the Fortress Companies achieve their goals. Fortress and the
Fortress Companies may seek licensings, acquisitions, partnerships,
joint ventures and / or public and private financings to accelerate
and provide additional funding to support their research and
development programs. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
anticipation of benefits from Orphan Drug Designation for CK-101,
our growth strategy and product development programs, and any other
statements that are not historical facts. Forward-looking
statements are based on management’s current expectations and are
subject to risks and uncertainties that could negatively affect our
business, operating results, financial condition and stock price.
Factors that could cause actual results to differ materially from
those currently anticipated are: the risk that Checkpoint will not
be able to advance its research programs; risks related to the
timing of starting and completing of clinical trials; risks
inherent in research and development activities; risks related to
its growth strategy; its ability to obtain, perform under and
maintain financing and strategic agreements and relationships;
uncertainties relating to preclinical and clinical testing; its
dependence on third-party suppliers; its ability to attract,
integrate, and retain key personnel; the early stage of products
under development; its need for substantial additional funds;
government regulation; patent and intellectual property matters;
competition; as well as other risks described in Checkpoint’s
public filings and reports. Checkpoint expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law.
Contacts: Jaclyn JaffeCheckpoint Therapeutics,
Inc. (781) 652-4500 ir@checkpointtx.com
Fortress Biotech Media RelationsLaura Bagby6 Degrees(312)
448-8098lbagby@6degreespr.com
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