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Patent covers NT219’s combinations with multiple 2nd and 3rd generation EGFR inhibitors, including osimertinib (TAGRISSO®)
TEL AVIV, Israel, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, today announced receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application entitled “Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer”. The patent, which expires in 2036, covers Kitov’s NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers.
The patent application covers the various combinations of NT219 with multiple 2nd and 3rd generation EGFR inhibitors, including osimertinib (TAGRISSO®), a 3rd generation EGFR inhibitor approved in the U.S. for first-line treatment of EGFR-mutated non-small-cell lung carcinoma (NSCLC) with annual sales of more than $3 billion worldwide. In in-vitro studies using NSCLC cells with mutated EGFR (T790M), NT219 was shown to downregulate IRS1 and STAT3, and to synergize with osimertinib in suppressing cell proliferation. In addition, in a preclinical PDX model originated from osimertinib-resistant metastatic NSCLC, NT219 has demonstrated significant single-agent activity, and the combination of NT219 with osimertinib resulted in a synergistic effect, showing strong and statistically significant inhibition of tumor growth, compared to the use of osimertinib alone. These encouraging results suggest a potentially promising therapeutic avenue for NT219 that Kitov intends to explore in future clinical trials.
“We are very pleased with this new addition to our patent coverage in the U.S. for NT219, a potential treatment for many hard-to-treat cancers,” said Isaac Israel, Kitov’s Chief Executive Officer. “This is an important milestone that has strengthened our extensive IP portfolio and supports our goal of establishing a potential key market for NT219 in the U.S. We expect top-line data readout from our Phase 1/2 trial with NT219 in the second half of 2021.”
Kitov recently initiated a Phase 1/2 trial evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) or colorectal adenocarcinoma. Preliminary data from part one of the study encompasses a dose-escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors and is expected in the second half of 2021.
Posted In: KTOV
