CEL-SCI plummets 43% after phase 3 immunotherapy data misses primary endpoint. Shares of CEL-SCI Corp. (NYSE:CVM) have plummeted 43% after phase 3 data on its Multikine (leukocyte interleukin) immunotherapy candidate missed its primary endpoint for head and neck cancer.
Similarly Will multikine get FDA approval? Multikine has not been licensed or approved by the FDA or by any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
What is multikine? A mixture of different immune molecules, potentially simulating the natural immune system: Multikine is composed of a defined mixture of naturally occurring molecules which in early-phase studies have been reported to be biologically/immunologically active.
Additionally, How does multikine work?
Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer.
Will Cel-Sci get FDA approval?
FDA Approval Is Highly Likely. CEL-SCI announced that the clinical trial results showing safety and efficacy with strong statistical power will form the basis of a Biologics License Application (BLA) to be filed with FDA.
