Kitov Pharma has recently announced new data that supports NT219 as monotherapy for the treatment of advanced solid tumors.
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Data Underpins Potential of NT219 to Overcome Advanced Solid Tumors
Kitov Pharma Ltd. (Kitov) is a clinical-stage drug developer using cutting-edge therapies to overcome drug resistance and tumor immune evasion.
The company’s preliminary aim is to create long-lasting treatments for cancer patients.
Kitov’s Kitov’s oncology pipeline includes NT219 and CM24.
They announced the news of the further supporting potential of NT219 and further clinical trials at the Epigenetics and Metabolism AACR Special Virtual Conference at Tel-Aviv University, Israel, on October 16, 2020.
The details were provided as part of the company’s alliance with the Head of the Oncology Division, Tel Aviv Sourasky Medical Center, Professor Ido Wolf.
What is NT219?
The small molecule is addressing treatment resistance in advanced cancer. NT219 is a dual inhibitor, novel agent targeting cancer drug-resistant pathways IRS1/2 and STAT3.
Previous studies with NT-219 showed its effectiveness in controlling drug resistance in various cancers in synergy with different cancer therapies. It has already demonstrated compelling anti-tumor activity of subjects with head and neck squamous cell carcinoma.
Animal studies demonstrated that NT-219, combined with Keytruda (a humanized antibody used in cancer immunotherapy), actually reversed the resistance that mice with esophagus cancer had developed to the antibody.
Clinical Trials
Phase 1/2 clinical trial of NT219 has been approved by the U.S. Food and Drug Administration (FDA) after they accepted Kitov’s Investigational New Drug (IND) application.
The open-label Phase 1/2 trial’s main aim is to assess the safety and evaluate pharmacokinetics, i.e., to determine the drug’s fate once administered to human subjects. The trials also hope to pinpoint the suitable dose required to be studied in Phase 2 and establish the effectiveness of NT219.
Patients with refractory advanced solid tumors will be given a dose of the NT219 drug each week.
A further group of patients with either colorectal adenocarcinoma or recurrent or metastatic squamous cell carcinoma of the head and neck will be given weekly doses of NT219 combined with cetuximab.
When a suitable dose has been found for both sets of mono and combination therapy, Phase 2 can start with a higher number of patients.
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Announcements From Kitov
Bertrand Liang, M.D., Ph.D., who is Chief Medical Officer of Kitov, said: “The acceptance of our IND by the FDA to conduct this important clinical study represents a significant achievement for our NT219 development program.”
“This new mechanism of action data, together with the compelling results from our preclinical studies of NT219, further supports the rationale behind combining immune-oncology targeted and immune oncology approaches, both in peripheral and nervous system tumor tissues,” Liang said.
He went on to say, “we are currently enrolling patients in our Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for solid metastatic recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma. We expect top-line data from the first part of this important study in the second half of 2021.”
“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.”
Summary Points
- Kitov Pharma has started the Phase 1/2 trial of NT219 as a treatment for advanced solid tumors.
- NT219 is a small molecule dual inhibitor targeting IRS1/2 and STAT3, mutated gene markers, and drug resistance in advanced solid tumors.
- Studies will combine cetuximab, an antibody that blocks the function of proteins found in cancer cells.
- Treatment will focus on recurrent and metastatic squamous cell carcinoma of the head and neck.
- The trial aims to assess the drug’s safety in human subjects and find a suitable dose for the next clinical trial stage.
- Kitov hopes to have initial data from the first part of the Phase 1/2 trial in H2 2021.
- Kitov has also partnered with Bristol Myers Squibb Company, who wants to start clinical trials to assess CM24 with the PD-1 inhibitor nivolumab (Opdivo®).
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Sources:
- New Mechanism of Action Data for NT219 Presented at Epigenetics and Metabolism AACR Special Virtual Conference
- Kitov Announces U.S. FDA Acceptance of Investigational New Drug Application to Conduct Phase 1/2 Clinical Trial of NT219 in Multiple Types of Advanced Cancer Patients
