Elicio Therapeutics and NCI are working together to characterize T cell responses to ELI-002 in animals.
The collaboration will be led by James Yang, senior investigator in the Surgery Branch of the Center for Cancer Research at NCI.
Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an “AMP KRAS-vaccine” containing seven amphiphile mKRAS peptides and a proprietary amphiphile adjuvant, administered subcutaneously.
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. ELI-002 has completed preclinical validation, IND-enabling GLP toxicology studies, and a pre-IND meeting with the FDA. P1/2 trials will be multi-site, starting with an open label dose escalation, progression to expansion cohorts in KRAS mutated solid tumors, and seamlessly progressing into a randomized, controlled cohort.
“This research investigates the mechanism of action of ELI-002 in mice that have key human HLA genes important for immune response,” Christopher Haqq, Elicio’s executive vice president, head of Research and Development, and chief medical officer, said in a statement. “Dr. Yang is a pioneer of T cell therapy for solid tumors, and we are excited to collaborate in the study, which may help monitor patient responses in the planned clinical study of ELI-002, and would set the stage for clinical trials combining ELI-002 with KRAS targeting T cells.”
The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the “brain center” of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Elicio’s ELI-002 targets seven position 12 and 13 KRAS mutations, present in approximately 25% of all human solid tumors. ELI-002 has the potential to become a multi-targeted mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian.
