Company Expects to Initiate Phase 1/2 Trial of NT-219 as Monotherapy Treatment of Advanced Solid Tumors and in Combination with cetuximab for Treatment of Recurrent or Metastatic Solid Tumors and Head and Neck Cancer
TEL AVIV, Israel, May 19, 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 that preclinical data for NT219, a novel agent addressing treatment resistance in advanced cancer, will be presented in a poster at the American Association of Cancer Research (AACR) Virtual Meeting II.
The presentation, titled, “NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models,” includes preclinical data on NT219, a first-in-class, dual inhibitor of signal transducer and activator of transcription 3 (STAT3) and insulin receptor substrate 1 and 2 (IRS1/2), which have been associated with treatment resistance in a variety of cancer settings. Using multiple patient derived xenograft (PDX) models of subjects with head and neck squamous cell carcinoma (HNSCC), NT219 demonstrated growth inhibition, both as monotherapy (3/6 mice), as well as in combination with cetuximab, an epidermal growth factor receptor (EGFR) inhibitor, or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor (5/6 mice). Notably, in one study of a PDX model of a recurrent/metastatic HNSCC sample that was resistant to radiation, various chemotherapies and pembrolizumab, utilizing NT219 alone resulted in tumor growth inhibition (TGI) of 69% (p=0.017). Moreover, while cetuximab alone was not effective (TGI=17%), the combination of cetuximab with NT219 showed synergistic effect and induced regression of all tumors (p=0.001).
“These encouraging preclinical data strongly suggest that the inhibition of the STAT3 and IRS-AKT pathways has the potential to address the tumor resistance phenotype,” said Isaac Israel, Chief Executive Officer of Kitov. “Based on the significant compelling preclinical evidence generated in various studies with NT219, including these data, our planned Phase 1/2 trial of NT219 will evaluate our promising product candidate both as a monotherapy treatment in patients with advanced solid tumors and in combination with cetuximab in patients with HNSCC. We look forward to initiating this Phase 1/2 trial soon.”
|Title:||NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models|
|Date:||June 22, 2020|
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company focusing on advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, to create successful long-lasting treatments for people with cancer. Kitov’s oncology pipeline includes NT-219 and CM-24. NT-219 is a small molecule targeting the novel cancer drug resistance pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 in combination with cetuximab as a third-line or second-line treatment option for the treatment of recurrent and metastatic squamous cell carcinoma of head & neck cancer (SCCHN) as well as a single agent monotherapy treatment in patients with advanced solid tumors in a planned Phase 1/2 study. CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Kitov plans to advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors in selected cancer indications in a Phase 1 study followed by a Phase 2 for the treatment of non-small cell lung cancer NSCLC and pancreatic cancer. Kitov has entered into a clinical collaboration agreement with Bristol Myers Squibb Company (BMY) for the planned Phase 1/2 clinical trials to evaluate the combination of CM-24 with the PD-1 inhibitor nivolumab (Opdivo®). Kitov is also the owner of Consensi™, a fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension which was approved by the FDA for marketing in the U.S in May 2018, and is expected to be launched in the near future in the U.S. by Kitov's partner Coeptis Pharmaceuticals. Kitov has also partnered to commercialize Consensi in China and South Korea. The company is headquartered in Tel Aviv, Israel. For more information, please visit http://www.kitovpharma.com.