Elicio Therapeutics’ lead cancer vaccine asset, ELI-002, has been found to improve survival outcomes in patients with hard-to-treat solid tumours.
In the Phase I AMPLIFY-201 trial (NCT04853017), the mutant-Kirsten rat sarcoma (KRAS)-targeting jab was found to reduce the risk of death in patients with both pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer by 77%, while reducing the risk of relapse by 88%.
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Tumour biomarker responses were observed in 84% of patients, with complete biomarker clearance in 24% of patients.
At the extended follow-up cut-off, median relapse-free survival (mRFS) in treated patients reached 16.33 months while overall survival (OS) reached 28.94 months.
Patients who gained the most benefit from ELI-002 all had strong mKRAS-specific T-cell responses exceeding the antitumour efficacy threshold, with these patients not reaching mRFS or OS during the follow-up.
The data suggest that ELI-002 could initiate significant, durable immune responses for patients in these indications, which are often associated with poor outcomes upon diagnosis.
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By GlobalDataThe data, also published in Nature Medicine, appears to be grabbing the attention of investors, with Elicio’s stock value rising by 14.8% from $8.65 at market close on 11 August to $9.93 when the market opened on 12 August after the announcement was made.
The cancer vaccine consists of a KRAS peptide antigen and an immune-stimulatory oligonucleotide, which target the body’s T-cells – encouraging them to identify and destroy cancer cells expressing mKRAS antigens.
Delivered through Elicio’s Amphiphile (AMP) platform, ELI-002 is transported directly to the lymph nodes, which can activate and amplify the activity of the adaptive immune system against KRAS-mutated tumours. Through this mechanism, the jab has shown potential in a range of solid tumour indications.
The vaccine is also being investigated in the Phase II AMPLIFY-7P trial (NCT05726864).
Drugging the ‘undruggable’
At present, the National Cancer Institute (NCI) estimates that KRAS mutations are found in approximately one-third of all cancers, highlighting its key role in the disease’s pathology.
Despite KRAS mutations being a strong contributor to poor patient outcomes in oncology, therapies targeting the protein have been challenging to develop – primarily due to its lack of binding pockets and strong affinity to the activating molecule, guanosine triphosphate (GTP).
However, there are some promising therapies targeting KRAS in late-stage trials, with Revolution Medicines’ GTP-bound KRAS G12 inhibitor, daraxonrasib, receiving breakthrough therapy designation from the US Food and Drug Administration (FDA) for PDAC in June 2025.
Revolution hopes to complete enrolment for the Phase III RASolute 302 (NCT06625320) trial by the end of the year, the company said in a 23 June statement. If approved, GlobalData forecasts that the drug will reach blockbuster status by 2029, while raking in $2.1bn by 2031.
GlobalData is the parent company of Clinical Trials Arena.
Meanwhile, mRNA-based cancer vaccines have also proven promising in early-stage trials, with BioNTech and Genentech’s candidate autogene cevumeran eliciting durable CD8 responses in PDAC as an adjuvant to PDL-1 inhibitor Tecentriq (atezolizumab).
The companies have now initiated Phase II trials involving autogene cevumeran as an adjuvant to standard of care (SoC) chemotherapy, with the colorectal cancer trial anticipated to read out in late 2025 or early 2026.
However, US Health Secretary Robert F Kennedy Jr’s (RFK Jr) call to cut funding to 22 mRNA vaccine projects could spell trouble for the sector, potentially slowing pipeline progression and restricting development opportunities within this modality.
This could give non-mRNA-based vaccines such as ELI-002 a better chance at obtaining funding for clinical-stage development, as well as a market head start if approved. However, it is still unclear what impact RFK Jr’s decision will have on the market.
