Kitov Pharma Ltd. (NASDAQ/TASE: KTOV) is an innovative pharmaceutical company developing first-in-class combination oncology therapies. Today they announced a key milestone in the acquisition of FameWave Ltd., following signature of a clinical collaboration agreement between FameWave and Bristol Myers Squibb (NYSE:BMY) for their planned Phase 1/2 clinical trials to evaluate the combination of CM-24, a monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) with nivolumab (Opdivo®), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC).
“We look forward to completing the acquisition of FameWave and advancing CM-24 studies in the clinic,” said Isaac Israel, chief executive officer of Kitov. “Our goal is to assess the innovative combination of CM-24 with Opdivo® In NSCLC patients. Since we believe CM-24 has great potential as a novel checkpoint inhibitor to be used in combination therapies to provide new options to address the significant unmet medical need in hard-to-treat cancers.”
Preclinical studies have shown a strong synergetic anti-cancer effect using CM-24 in combination with a PD-1 antibody. Based on Kitov’s review of the initial Phase I dose ranging study of CM24 as a single agent, performed by Merck Sharpe & Dohme, Kitov plans to explore higher doses in order to reach receptor saturation.
Kitov is acquiring FameWave, pending completion of certain additional closing conditions, including approval by the shareholders of Kitov of the acquisition.
CEACAM1 and CM-24
CM-24 is a humanized monoclonal antibody directed against carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has shown that CEACAM1 is expressed on tumor lymphocytes and is up-regulated in several cancer types. Preclinical studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein.
As part of the recently announced agreement for the acquisition of FameWave by Kitov, cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as “MSD” in Israel, has returned the rights to CM-24 to former cCAM shareholders and founders of FameWave, following an initial Phase 1 dose ranging study of CM-24 as single agent.