Kitov Pharma Issues CEO Shareholder Letter Providing Business Update - Seite 2

In addition, with a strong balance sheet that includes no debt, we have the flexibility to enhance our growth through smart acquisitions and/or in-licensing activity that we may identify in our core focus area of oncology. We expect to identify promising drug candidates with unique differentiation that have the potential to create exciting new treatment paradigms for the benefit of cancer patients. Our core objective is to become a recognized leader in the oncology field and to make a significant impact on patients’ lives.

An important aspect of our strategy is to collaborate with third-parties. As a result of our recent financing activity, our current balance sheet provides us with the ability to maximize the value of the strategic opportunities that we are pursuing. We look forward to providing you with further updates on these ongoing activities as events warrant.

I would like to provide an update on our current pipeline and CONSENSI:

CM24:

On May 14, 2020, we announced that the positive results of a previously reported Phase 1 trial of CM24 were presented in a poster presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program. 

These Phase 1 results are encouraging and indicate that CM24 at higher doses warrants further evaluation in a larger clinical study. Importantly, pharmacokinetic modelling suggests that higher doses of CM24 of up to 20mg/kg administered every two weeks would be required for target saturation.  We look forward to the anticipated initiation of our planned Phase 1/2 clinical trial to evaluate the combination of CM24 with the PD-1 inhibitor, nivolumab (OPDIVO), to be conducted in collaboration with Bristol Myers Squibb, which we expect to initiate in the second half of this year. In order to maximize the potential of the trial to demonstrate a strong efficacy signal, we intend to include expansion cohorts that will follow the dose escalating phase: an expansion cohort in non-small cell lung cancer patients, and an additional expansion cohort in pancreatic cancer patients. This new arm of the trial in pancreatic cancer patients is designed to evaluate the CEACAM1/PD-1 combination in addition to standard of care chemotherapy.