Checkpoint Therapeutics Initiates Phase 1 Study of Anti-PD-L1 Antibody CK-301
October 05 2017 - 07:30AM
Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ:CKPT), a
Fortress Biotech (NASDAQ:FBIO) company, today announced that the
first patient has been dosed in a Phase 1 clinical study evaluating
the safety and tolerability of CK-301 in checkpoint therapy-naïve
patients with selected recurrent or metastatic cancers.
CK-301 is a fully human monoclonal antibody that
binds to Programmed Death-Ligand 1 (“PD-L1”) and blocks its
interaction with the Programmed Death-1 (“PD-1”) and B7.1
receptors. This has the potential to lead to the recovery of an
anti-tumor immune response and the immune-mediated eradication of
tumors.
James F. Oliviero, President and Chief Executive
Officer of Checkpoint, stated, “We are proud to announce that our
first immuno-oncology asset has entered the clinic, and look
forward to assessing its potential as a therapeutic option in many
oncological indications, both as a monotherapy and in combination
with other targeted therapies and anti-tumor, immune-response
potentiating compounds.”
Mr. Oliviero continued, “The targeting of PD-L1
to block the PD-1/PD-L1 pathway has become well-validated in cancer
immunotherapy, which may significantly reduce the clinical
development timeline for CK-301. By enrolling only checkpoint
therapy-naïve patients, we expect to see signals of efficacy in
both the dose escalation and expansion portions of the study,
potentially enabling our first registration study by the end of
next year. We look forward to providing clinical updates on the
study in the first half of 2018.”
Additional information on the study can be found
on www.clinicaltrials.gov using the identifier NCT03212404.
About the Phase 1 CK-301
StudyThe first-in-human, Phase 1, open-label, multicenter
study is evaluating the safety and tolerability of ascending doses
of CK-301 in checkpoint therapy-naïve patients with selected
recurrent or metastatic cancers. Secondary endpoints include the
evaluation or characterization of the pharmacokinetics,
immunogenicity and preliminary efficacy of CK-301. Following dose
escalation, up to four dose-expansion cohorts may be enrolled to
further characterize the safety and efficacy of CK-301 in specific
patient subgroups. The study will initially enroll patients in
study sites across Australia and New Zealand.
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 a
majority-controlled subsidiary of Fortress Biotech, Inc., and is
headquartered in New York City. For more information, visit
www.checkpointtx.com.
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
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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