On June 27, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a pharmaceutical company focused on advancing first-in-class oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression, reported that it has successfully completed the laboratory phase of the IND-enabling studies for NT219, a first-in-class, dual-inhibitor small molecule, designed to prevent and overcome cancer drug resistance (Press release, Kitov Pharmaceuticals , JUN 27, 2019, View Source [SID1234537321]). The preclinical GLP toxicology studies have demonstrated good tolerability at the highest dose levels expected to be tested in Kitov’s planned Phase 1/2 study treating patients with squamous cell carcinoma of the head and neck (SCCHN).
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"We are excited with the completion of the IND-enabling studies for NT219 which advances our growing oncology pipeline to the clinic," stated Isaac Israel, chief executive officer of Kitov. "Our planned development of NT219 is based on strong preclinical evidence demonstrating that the combination of NT219 with the EGFR antibody cetuximab has potential clinical benefits for patients with recurrent or metastatic SCCHN whose cancer has not responded or has become resistant to early-line immuno-oncology or chemotherapy treatments. Pending a smooth regulatory review process, we look forward to initiating a Phase 1/2 trial with NT219 and cetuximab in the U.S. by the end of 2019."
Kitov is preparing for completion of the GMP manufacturing of the drug product and submission of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a dose-escalation Phase 1/2 study to treat SCCHN cancer patients with the combination of NT219 and cetuximab.
About NT-219
NT219, is a first-in-class small molecule designed to prevent and overcome cancer drug resistance. NT-219 is an inhibitor of two signaling proteins involved in drug resistance, Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer and Activator of Transcription 3 (STAT3). Efficacy of NT-219 was demonstrated in PDX models in combination with targeted therapies, chemotherapies and immuno-oncology therapies in delaying onset and reversing resistance to anti-cancer drugs in head and neck, colon, lung, and pancreatic cancers. Kitov is planning to initiate a Phase 1/2 open label multi-center study of NT-219 in combination with cetuximab (ErbituxTM) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) by the end of 2019.