Elicio Therapeutics has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for ELI-002. ELI-002 is an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant, administered subcutaneously. The company's novel therapeutic vaccine targets KRAS mutations that drive 99% of all KRAS-driven cancers. Phase I/II clinical trials of ELI-002 will enroll patients with mKRAS+ pancreatic ductal adenocarcinoma (PDAC) and other solid tumors. 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. Elicio is developing ELI-002 to treat and prevent disease recurrence with potential to help one quarter of solid tumor patients.
"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 Executive Vice President, Head of Research and Development, and Chief Medical Officer. "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."
Elicio's Phase I/II trial will identify patients with PDAC and other solid tumors who have undergone standard of care surgery and neoadjuvant/adjuvant chemotherapy, that have persistent positive circulating tumor DNA indicating likely recurrence and rapid progression. Patients are studied in a window of opportunity after standard therapy is complete but before their tumors have had a chance to grow to a size where they are normally seen in radiographic scans.
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"To date, 'drugging' mKRAS directly has only been achieved in recent clinical trials for the G12C allele, using covalent inhibitors. Most human tumors have different mutations, where G12C is not a driver mutation. The ELI-002 therapeutic vaccine covers 99% of all mKRAS tumors creating the opportunity for improved durability of response and eradication of cancer," said Julian Adams Ph.D., chief executive officer of Gamida Cell and Chairman of Elicio Therapeutics' Board of Directors.
ELI-002 is an "AMP KRAS-vaccine" containing Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, AMP CpG, administered subcutaneously. Elicio's ELI-002 targets KRAS mutations, present in approximately 25% of all human solid tumors. The Amphiphile mKRAS peptides and Amphiphile CpG are targeted directly to the lymph node as a result binding to tissue albumin after injection, leading to accumulation of the complex into lymph nodes where the peptides and CpG payloads are delivered directly to key immune cells resulting in unprecedented efficiency. ELI-002 has the potential to become a multi-targeted mKRAS therapeutic vaccine 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. Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy amplifiers to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses.