NEW YORK, March 21, 2018 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ:CKPT), a
clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel
treatments for patients with solid tumor cancers, today announced the completion of the dose escalation portion of the ongoing
Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and the
initiation of the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “The completion of the dose
escalation portion of our Phase 1 trial marks an important milestone in the clinical development of our anti-PD-L1 antibody,
CK-301. Our focus now shifts to generating efficacy data in the dose expansion portion of the trial through the enrollment of
patients with tumor types believed to have a high potential for objective response to anti-PD-L1 monotherapy. We look forward to
reporting initial data from this expansion cohort in the second half of 2018, and are targeting the initiation of our first
registration trial in first-line non-small cell lung cancer in the first quarter of 2019.”
Preliminary data from the dose escalation portion of the Phase 1 trial suggest that CK-301 is safe and well
tolerated across three fixed dose levels ranging from 200 mg to 800 mg administered every two weeks. Treatment-related adverse
events were mild to moderate and consistent with other approved PD-L1 antibodies. No dose-limiting toxicities have been reported
and no patients have discontinued therapy to date.
Based on these data, Checkpoint has commenced its first dose expansion cohort evaluating the fixed dose of 800
mg, the highest dose tested in dose escalation, every two weeks in up to 40 checkpoint therapy-naïve patients with select tumor
types associated with high clinical response rates to anti-PD-1/L1 monotherapies, with a priority on enrolling first-line non-small
cell lung cancer patients whose tumors have high PD-L1 expression.
Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03212404.
About the Phase 1 CK-301 Trial
The Phase 1, first-in-human, open-label, multicenter trial 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 trial is currently enrolling patients at sites across Australia, New Zealand and Thailand.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage, immuno-oncology biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is currently
evaluating its lead product candidate CK-301, a fully human anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in
a Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Checkpoint plans to
develop CK-301 as a treatment for patients with non-small cell lung cancer (“NSCLC”) and other solid tumors. In addition,
Checkpoint is evaluating its small-molecule, targeted anti-cancer agent, CK-101, in the Phase 1 portion of a Phase 1/2 clinical
trial for the treatment of patients with epidermal growth factor receptor (“EGFR”) mutation-positive NSCLC. Checkpoint’s pipeline
also includes antibodies that target glucocorticoid-induced TNFR-related protein (“GITR”) and carbonic anhydrase IX (“CAIX”), in
addition to oral, small-molecule, targeted anti-cancer agents that inhibit bromodomain and extra-terminal (“BET”) proteins and poly
(ADP-ribose) polymerase (“PARP”). 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 Biotech
Fortress Biotech, Inc. (“Fortress”) (NASDAQ:FBIO) 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. 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 licensing
arrangements, 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 Statements
This 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, each as amended. 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 value. Factors that could cause actual results to
differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform
under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development
activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and
clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early
stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual
property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim 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.
Company Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com
Investor Relations Contact:
Jeremy Feffer
Managing Director, LifeSci Advisors, LLC
(212) 915-2568
jeremy@lifesciadvisors.com
Media Relations Contact:
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com