Researchers have disclosed the final outcomes of the AMPLIFY-201 clinical trial, which assessed the safety profile and efficacy of the ELI-002 2P vaccine. This therapeutic agent is designed to elicit an immune response against tumors harboring KRAS gene mutations frequently observed in pancreatic and colorectal cancers.
The trial involved 25 participants who had previously undergone standard therapy and presented with minimal residual disease. The vaccine formulation comprised amphiphilic peptides targeting KRAS G12D and G12R mutations, along with an adjuvant intended to facilitate antigen delivery to the lymph nodes.
Following an average follow-up period of 19.7 months, it was determined that a robust immune response against mutated KRAS directly correlated with a delay in disease progression. For patients exhibiting T-cell expansion exceeding a predefined threshold, the median time to recurrence was not reached, whereas in the low-response group, this median was approximately three months. Overall survival also showed significant improvement among those with a strong immune reaction.
A discernible T-cell response developed in 84% of the participants, with most showing a simultaneous response from both CD4+ and CD8+ cells. Over two-thirds of the patients exhibited what is termed “antigen spread,” meaning their immune systems began recognizing additional tumor mutations beyond those included in the vaccine formulation.
The investigators point out that the vaccine demonstrated a durable effect and favorable safety metrics. This evidence bolsters further investigation into this technology, including upcoming randomized controlled trials. Phase 2 studies for a new iteration of the ELI-002 vaccine, which incorporates a broader spectrum of KRAS and NRAS mutation targets, have already commenced.
The authors suggest that amphiphilic vaccines, engineered for targeted antigen delivery to lymphatic tissues, hold substantial promise as a future avenue in the immunotherapy of solid tumors, particularly for patients facing a high risk of relapse.
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