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Checkpoint Therapeutics (CKPT) Starts CK-301 Trials



Checkpoint Therapeutics (NASDAQ:CKPT) announces the dosing of its first patient in a Phase I trial for CK-301, which we discuss in a prior article.  CK-301 is a fully human monoclonal IgG1 antibody targeting PD-L1 and B7.1 receptors.  The trial is an open label, dose escalation study which will examine the safety and tolerability of intravenously administered CK-301.  The patient pool includes checkpoint therapy-naïve patients with selected recurrent or metastatic cancers.

The study will enroll an estimated 80 individuals and consist of three segments.  A 28-day screening period, followed by a 28-day treatment period and follow-up of six months.  Primary endpoints are evaluation of dose limiting toxicities and observation of adverse events.  Secondary endpoints will examine response rates, several pharmacokinetic parameters and the number of patients with anti-CK-301 antibodies.  The company expects to provide interim updates in 1H:18.

If the Phase I trial shows positive safety and signals for efficacy, Checkpoint will be on track for CK-301’s first registrational study before the end of 2018.

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