Elicio Therapeutics Shares Updated ELI-002 Phase 1 Results at 2024 ESMO Congress

Elicio Therapeutics, a biotechnology company listed on Nasdaq as ELTX, is advancing the treatment of cancer through its innovative immunotherapy pipeline. The company recently shared updates on the Phase 1 AMPLIFY-201 clinical trial of ELI-002, a cancer vaccine aimed at targeting KRAS-mutant tumors. These findings were presented at the ESMO Immuno-Oncology Congress 2024 in Geneva, Switzerland, offering promising insights into the treatment of KRAS-driven colorectal and pancreatic cancers.

ELI-002 has been evaluated in patients with KRAS mutations in colorectal or pancreatic cancer, who are at high risk of disease recurrence even after standard treatment. The trial's latest data reveals a median recurrence-free survival (mRFS) of 16.3 months and a median overall survival (mOS) of 28.9 months within the full study cohort. These outcomes were observed over a median follow-up period of 19.7 months, reinforcing ELI-002's favorable safety profile and significant ability to elicit a T cell response in patients.

The trial involved 25 participants, including 20 individuals with pancreatic ductal adenocarcinoma (PDAC) and five with colorectal cancer (CRC). Each participant successfully underwent surgical tumor resection but remained at risk of relapse due to minimal residual disease (MRD). Elicio's AMP technology, a key component of the vaccine, is designed to enhance T cell responses against KRAS mutations. The study's findings indicated a strong correlation between robust T cell responses and improved survival outcomes, highlighting the vaccine's potential to mitigate the risk of cancer progression.

In the trial, participants received varying doses of the ELI-002 two-peptide formulation, ranging from 0.1 mg to 10.0 mg. The results indicated that patients with higher-than-average T cell responses did not reach mRFS, while those with lower responses had a mRFS of 4.0 months. These results suggest that the strength of the T cell response may be a critical factor in determining the vaccine's effectiveness.

Furthermore, the study observed similar mRFS across both the PDAC and CRC subgroups and the overall cohort. The mOS for the PDAC subgroup matched the overall cohort's survival rate, showing a favorable comparison to historical data for pancreatic cancer patients. The CRC subgroup’s mOS was not reached, suggesting potential long-term benefits.

Elicio’s AMP platform, initially developed at MIT, focuses on delivering immunotherapeutics directly to the lymph nodes, which are crucial for immune system activation. This targeted approach may enhance the body’s ability to sustain a potent immune response necessary for combating cancer. The platform’s ability to drive immune responses with increased magnitude and durability has shown promise in preclinical studies.

The results from the AMPLIFY-201 trial are encouraging as Elicio continues to develop its AMP technology and vaccine pipeline. The next step involves an interim analysis of a randomized Phase 2 trial of ELI-002 7P, which is ongoing and expected to be completed in the first half of 2025. This trial will further evaluate the vaccine’s effectiveness in a broader patient population by targeting additional KRAS mutations.

Elicio Therapeutics remains committed to advancing its novel cancer immunotherapy programs, aiming to provide effective off-the-shelf vaccines to prevent cancer recurrence in patients with high-risk KRAS mutations. The company's continuous efforts in clinical trials and drug development reflect its dedication to enhancing cancer treatment options and improving patient outcomes.