Checkpoint Therapeutics Reports Preclinical Data for Two Oncology Programs
April 04 2017 - 1:00PM
Checkpoint Therapeutics, Inc. (“Checkpoint”) (OTCQX:CKPT), a
Fortress Biotech (NASDAQ:FBIO) company, today announced that
preclinical data on its third-generation epidermal growth factor
receptor (“EGFR”) inhibitor, CK-101, and anti-programmed cell death
ligand-1 (“PD-L1”) antibody, CK-301, were presented this week in
poster sessions at the American Association for Cancer Research
(AACR) Annual Meeting. The data presented strongly support the
clinical development of these therapies.
James F. Oliviero, President and Chief Executive Officer of
Checkpoint, said, “These encouraging preclinical data demonstrate
the potential of our EGFR inhibitor and anti-PD-L1 checkpoint
antibody to be effective new treatment options for patients
suffering from cancer. We look forward to advancing these drug
candidates through the stages of clinical development, both as
monotherapies as well as in combination with each other.”
Key conclusions from the posters are as follows:
CK-101 (RX518), a Mutant-Selective Inhibitor of EGFR
that Overcomes T790M-Mediated Resistance in Non-Small Cell Lung
Cancer (NSCLC)
CK-101 (also known as RX518) is a novel, irreversible, orally
administered EGFR kinase inhibitor that specifically targets the
mutant forms of EGFR, including T790M, while exhibiting minimal
activity toward the wild-type EGFR. Cell proliferation assays in
human cancer cell lines in vitro, and xenograft studies conducted
in mouse models of NSCLC demonstrated:
- CK-101 is a potent, mutant-selective inhibitor of both the
activating (exon 19 deletion) and resistance mutations (L858R /
T790M double mutation).
- CK-101 inhibited tumor growth as a single agent in a NSCLC
model with a single activating mutation (exon 19 deletion).
- CK-101 showed dose-dependent inhibition of tumor growth as a
single agent in a L858R / T790M double mutant NSCLC model.
- CK-101 has little inhibitory potency toward wild-type EGFR
(i.e., CK-101 was more than 100-fold less potent against wild-type
EGFR than against L858R / T790M double mutation).
These data supported the initiation of a Phase 1/2 clinical
trial in September 2016 (ClinicalTrials.gov: NCT02926768). The
Phase 1 dose-escalation portion is ongoing, and Checkpoint expects
to initiate the Phase 2 portion in patients with EGFR T790M
mutation‐positive NSCLC cancer in the second half of 2017.
Preclinical Characterization of a Novel Fully Human IgG1
Anti-PD-L1 mAb CK-301
Based on the various assays performed, the poster concluded:
- CK-301 is a high affinity PD-L1 specific fully humanized lgG1
antibody which blocks binding of PD-L1 to PD-1.
- Activity of CK-301 in all assays tested was similar to
anti-PD-L1’s used as active controls (surrogates of avelumab,
atezolizumab or durvalumab).
- Similar to the approved anti-PD-L1, avelumab, CK-301 has the
potential to induce ADCC (antibody-dependent cell-mediated
cytotoxicity).
A first-in-human Phase 1 study of CK-301 is planned to commence
this year.
The posters are available on the Publications page within the
Pipeline section of Checkpoint’s website, www.checkpointtx.com.
About Checkpoint TherapeuticsCheckpoint
Therapeutics, Inc. (“Checkpoint”), a Fortress Biotech company, 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 complimentary mechanisms. Checkpoint 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 of its subsidiary
companies, also known as Fortress Companies. Additionally, Fortress
recently acquired a controlling interest in National Holdings
Corporation (NASDAQ:NHLD), a diversified independent brokerage
company (together with its subsidiaries, “NHLD”). 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 Jaffe
Checkpoint Therapeutics, Inc.
781-652-4500; ir@checkpointtx.com
Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098; lbagby@6degreespr.com
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Apr 2023 to Apr 2024