Therapeutic Vaccine Candidate Targeting Mutated KRAS Cancers Cleared by FDA
Massachusetts-based Elicio Therapeutics announced it had received Investigational New Drug clearance from the U.S. Food and Drug Administration for ELI-002, an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant.
The company’s novel therapeutic vaccine targets KRAS mutations that drive 99% of all KRAS-driven cancers.
KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers.
“Previous vaccine approaches utilizing synthetic peptides have not effectively targeted the critical immune cells residing in the lymph nodes and have elicited only weak or undetectable immune responses in patients,” said Christopher Haqq, M.D., Ph.D., Elicio’s EVP, Head of Research and Development, and CMO, in a press release issued on February 23, 2021.
“The Amphiphile technology allows us to simultaneously generate immune response to all the mutations commonly present in KRAS driven cancers by targeting antigenic peptides with a powerful adjuvant directly to the lymph nodes, significantly amplifying the resulting immune responses, and producing highly functional mKRAS-specific T cells capable of destroying mKRAS positive cells like tumor cells.”
Phase I/II clinical trials of ELI-002 will enroll patients with mKRAS+ pancreatic ductal adenocarcinoma and other solid tumors.
Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases.