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Kitov Announces US FDA Acceptance Of Investigational New Drug Application To Conduct Phase 1/2 Clinical Trial Of NT219 In Multiple Types Of Advanced Cancer Patients

Company to Evaluate NT219 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 in a Phase 1/2 Trial TEL AVIV,

Benzinga · 05/22/2020 11:00

Company to Evaluate NT219 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 in a Phase 1/2 Trial

TEL AVIV, Israel, May 22, 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 the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical trial of NT219, a novel agent addressing treatment resistance in advanced cancer. The study will evaluate NT219 as monotherapy treatment of advanced solid tumors and in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

“The acceptance of our IND by the FDA to conduct this important clinical study represents a significant achievement for our NT219 development program,” said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov.  “Based on the encouraging preclinical data generated in various studies with NT219, we believe this promising drug candidate has the potential to be a safe and effective therapy for multiple treatment resistant cancers. We look forward to beginning to generate key clinical evidence for NT219 through this Phase 1/2 trial.”

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose to be given, a second cohort of patients, with either recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be dosed weekly with NT219, dose escalated, in combination with cetuximab. Upon completion of the mono and combination therapy Phase 1 portion of the trial and establishment of the recommended Phase 2 dose for NT219, an expansion Phase 2 component of the study will be commenced at the recommended Phase 2 dose of NT219 in combination with cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

In previously completed preclinical studies, NT219 has demonstrated compelling anti-tumor activity, as both monotherapy and in combination with cetuximab. Most recently, in an abstract published at the American Association of Cancer Research Virtual Meeting II website, positive preclinical data were presented showing that NT219 demonstrated growth inhibition, both as monotherapy, as well as in combination with cetuximab or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, in multiple patient-derived xenograft models of subjects with head and neck squamous cell carcinoma.