FameWave Announces Clinical Collaboration with Bristol Myers Squibb for the Planned Phase 1/2 Trial in Non-Small Cell Lung Cancer to Evaluate Immuno-Oncology Candidate CM-24 in Combination with Nivolu

April 12, 2019 7:50 AM

TEL AVIV, Israel, April 12, 2019 (GLOBE NEWSWIRE) -- FameWave Ltd. a privately held biopharmaceutical company developing CM-24, which is being acquired by Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), today announced the signing of a clinical collaboration with Bristol Myers Squibb Company (NYSE: BMY) to evaluate the combination of CM-24, FameWave’s 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).

FameWave and Bristol Myers Squibb will coordinate on the protocol design for the Phase 1/2 clinical trial in a well-defined patient population with NSCLC. Under the terms of the agreement, FameWave will fund and sponsor the study and Bristol Myers Squibb will supply nivolumab.

“FameWave’s collaboration with Bristol-Myers Squibb, a global leader in immuno-oncology, is a crucial step to begin evaluation of CM-24 in combination with a PD-1 inhibitor,” said Dr. Michael Schickler, chief executive officer of FameWave. “We look forward to evaluating CM-24 in NSCLC since we believe it has a great potential as a novel immune checkpoint to be used in combination therapies for a variety of hard-to-treat cancers.”

About 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 Pharma Ltd. (NASDAQ/TASE: KTOV), cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as “MSD” in Israel, is returning 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. Kitov’s acquisition of FameWave is pending completion of certain closing conditions, including FameWave entering this collaboration agreement for CM-24 with Bristol Myers Squibb.

Forward-Looking Statements and Safe Harbor Statement

Certain statements in this press release are forward-looking statements within the meaning of applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law.

For further information, contact:

Dr. Michael Schickler

972 8 932 4000


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