Elicio Therapeutics begins patient dosing in randomized phase 2 pancreatic cancer study

Elicio Therapeutics, Inc., a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, announced that the first patient has been dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York, as part of the randomized phase 2 (AMPLIFY-7P) study of ELI-002 7P as an adjuvant monotherapy in KRAS mutated pancreatic ductal adenocarcinoma (PDAC).

ELI-002 7P is an investigational therapeutic cancer vaccine developed with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to treat cancers driven by seven common mutations in KRAS (G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumour cancers and 88% of PDAC patients. This is in contrast to other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors — which target fewer mutations, potentially limiting the number of patients that can be treated and also limiting duration of benefit due to development of escape mutants.

“Approximately 90% of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1%, amenable to small molecule treatment,” said Christopher Haqq, M.D., Ph.D., Elicio’s executive vice president, head of research and development, and chief medical officer. “ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations.  The phase 2 study builds on positive findings from our 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating a significantly improved decrease in tumour biomarkers, along with strong T cell responses that correlated with a reduced risk of relapse and death.  We anticipate results from this study will yield definitive data to support clinical efficacy assessment.”

Elicio will present a Trial in Progress poster on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 in San Francisco, CA. Initial interim data on ELI-002 7P monotherapy from phase 1A arm will be shared in the first half of 2024.

ELI-002 is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by the ELI-002 7P formulation are present in 25% of all solid tumours. In particular, 93% of pancreatic ductal adenocarcinoma and 52% of colorectal cancers, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. In addition, 27% of non-small cell lung cancers are positive for KRAS mutations. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant available as an off-the-shelf subcutaneous administration. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells.

ELI-002 2P is currently being studied in a phase 1 trial (“AMPLIFY-201”) in patients with high relapse risk mKRAS-driven solid tumours, following surgery and chemotherapy (NCT04853017). ELI-002 7P, is currently being studied in AMPLIFY-7P, a phase 2 trial in patients with high relapse risk mKRAS-driven solid tumours (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.

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