On March 21, 2018 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, reported 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 (Press release, Checkpoint Therapeutics, MAR 21, 2018, View Source [SID1234525087]).
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."
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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 therapynaïve
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.