Elicio Therapeutics, Inc. (Nasdaq: ELTX) has announced encouraging clinical and corporate updates regarding its novel immunotherapies for cancer treatment. The company's lead vaccine candidate, ELI-002, is showing promise in patients with KRAS-mutated solid tumors, particularly pancreatic ductal adenocarcinoma (PDAC). Recent data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting and the American Association for Cancer Research (AACR) Special Conference highlight the potential of Elicio's Amphiphile (AMP) platform to improve cancer treatment outcomes.
ELI-002 Demonstrates Clinical Activity
Updated preliminary clinical data from the AMPLIFY-201 trial, a Phase 1 study assessing ELI-002 2P monotherapy, indicates that the vaccine induces T cell responses correlated with a significant reduction in the risk of progression and death. The data, presented at the AACR Special Conference, showed a median relapse-free survival (RFS) of 16.3 months in evaluable patients (n=22), with the median overall survival (OS) not yet reached. Furthermore, direct ex vivo polyfunctional mKRAS-specific T cell responses to ELI-002 2P were observed in 87% of patients, with T cell response in 100% of patients treated at the highest two dose levels, including the 10 mg RP2D.
At the SITC Annual Meeting, Elicio presented additional data demonstrating the durability of ELI-002 induced T cell responses to multiple KRAS mutations in the majority of treated patients. Specifically, 90% of immune responders had T cell responses to ≥ two mKRAS antigens, with 35% responding to all seven mKRAS antigens evaluated. Of the four evaluable patients assessed for durability of immune response post-boost immunization, 100% (4/4) maintained durable T cell responses above baseline with 75% (3/4) producing further increases post-boost.
Advancing ELI-002 7P into Phase 2
The company is accelerating the ELI-002 7P mutant KRAS monotherapy program into Phase 2, with an interim analysis expected in the first quarter of 2025. The AMPLIFY-7P trial, a multicenter Phase 1/2 study, is assessing ELI-002 7P in patients with high relapse risk mutant KRAS-driven solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, expanding the number of patients eligible for treatment and potentially reducing the chance of bypass resistance mechanisms. Enrollment in the randomized Phase 2 study is proceeding faster than expected, with completion anticipated in Q4 2024.
Preclinical Programs Show Promise
Elicio also presented preclinical data demonstrating its platform can induce robust immune responses against BRAF and p53 cancer driver mutations. Lymph node targeted AMP-vaccination resulted in T cell responses >10-500-fold increased over conventional vaccine comparators. Induced T cells were polyfunctional exhibiting production of multiple effector cytokines (IFNγ, TNFα, IL-2) and demonstrating cytotoxic killing in vivo alongside enhanced production of Granzyme B. These programs, ELI-007 (targeting mBRAF) and ELI-008 (targeting mTP53), are slated for potential clinical advancement in H1 2025.
Financial Update
Elicio reported a net loss of $18.8 million for the third quarter of 2024, which includes $8.5 million of non-cash other income resulting from the change in fair value of the warrant liability. Research and development expenses were $7.2 million, compared to $7.3 million for the third quarter of 2023. As of September 30, 2024, cash and cash equivalents were $26.0 million. The company expects its current cash position to support operations into the second quarter of 2025, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis.
