Kitov Successfully Completes IND-enabling Studies to advance NT219 for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancers

TEL AVIV, Israel, June 27, 2019 (GLOBE NEWSWIRE) -- 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, today announced 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. 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

“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.

About Kitov Pharma

Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is advancing first-in-class oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression. Kitov’s oncology pipeline includes NT219 a small molecule targeting novel cancer drug resistance pathways and Kitov is under contract to acquire 100% of FameWave Ltd. which owns CM-24, a humanized monoclonal antibody directed against carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein. Following the recent receipt of the approval of Kitov’s shareholders for the acquisition of FameWave, and the finalization of a clinical collaboration agreement between FameWave and Bristol Myers Squibb (BMY) for their planned Phase 1/2 clinical trials to evaluate the combination of CM-24 with nivolumab (Opdivo®), a PD-1 inhibitor, the acquisition is expected to close during the third quarter of 2019, subject to fulfillment of certain additional closing conditions. In addition, Kitov’s combination drug, Consensi™, treating osteoarthritis pain and hypertension simultaneously, was approved by the FDA for marketing in the U.S and is partnered in the U.S, China and South Korea

By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.