BOSTON, MASSACHUSETTS: Elicio Therapeutics is investigating an experimental pancreatic cancer vaccine called camupepimut (ELI-002 7P). The treatment targets mutated KRAS proteins, which play an important role in pancreatic cancer development.
The vaccine triggered strong immune responses in a Phase 2 clinical trial involving 144 patients. However, the study did not meet its primary disease-free survival endpoint, although several subgroup analyses showed encouraging results.
How the Vaccine Targets Cancer
Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer. Mutations in the KRAS gene occur in approximately 90% to 95% of these cancers.
The KRAS gene helps regulate cell growth and division. When it develops certain mutations, it can produce abnormal proteins that allow cancer cells to grow and survive.
These altered proteins also provide potential targets for cancer immunotherapy.
The experimental vaccine, camupepimut, trains the immune system to recognize seven common mutated KRAS variants:
- G12D
- G12R
- G12V
- G12A
- G12C
- G12S
- G13D
Unlike preventive vaccines used against infectious diseases, camupepimut is a therapeutic cancer vaccine. It is designed for patients who have already undergone cancer treatment and aims to help the immune system recognize and attack remaining cancer cells.
The vaccine combines seven modified KRAS peptide antigens with an immune-stimulating component called Amph-CpG-7909.
It also uses amphiphile (AMP) technology to improve the delivery of vaccine components to lymph nodes. These structures play an important role in activating immune cells and coordinating the body’s immune response.
The approach aims to activate CD4 and CD8 T cells. CD4 cells help coordinate immune activity, while CD8 cells can directly recognize and destroy abnormal cells. (George et al., 2026)
Inside the Phase 2 Trial
The latest findings come from the AMPLIFY-7P clinical trial, an open-label, randomized Phase 2 study conducted at 24 centers in the United States.
Researchers enrolled 144 patients with Stage I to III KRAS-mutated pancreatic cancer. All participants had undergone pancreatic surgery and chemotherapy.
They had no radiographic evidence of recurrence within six months of completing standard treatment.
Participants were divided into two groups:
| Study group | Participants |
|---|---|
| Camupepimut vaccine | 96 |
| Observation group | 48 |
The researchers followed patients for a median of 19.4 months, with the main data cutoff on April 20, 2026.
The primary objective was to determine whether the vaccine could improve disease-free survival (DFS), which measures how long patients remain free from cancer recurrence or death after treatment.
The findings were published in Nature Medicine on October 23, 2026. They were also discussed in MedPage Today’s TTHealthWatch podcast. (George et al., 2026)
Why the Main Endpoint Matters
The trial did not meet its primary disease-free survival endpoint in the overall study population.
Researchers reported the following median disease-free survival results:
| Parameter | Vaccine group | Observation group |
|---|---|---|
| Median disease-free survival | 23.8 months | 21.2 months |
The hazard ratio was 0.85, with a P-value of 0.5329. This means the overall comparison did not demonstrate a statistically significant improvement.
Researchers also observed a numerical difference during the first six months, which coincided with the vaccine treatment period.
At six months, 75.7% of patients in the vaccine group remained free from recurrence or death, compared with 61.7% in the observation group.
This represented a 14-percentage-point difference. However, the finding did not establish a statistically significant improvement across the overall population.
There were also differences in some baseline risk factors between the groups. For example, 20.8% of vaccine recipients had detectable circulating tumor DNA (ctDNA), compared with 12.5% in the observation group.
Similarly, R1 surgical margins, where cancer cells are present at or within 1 mm of the surgical margin, were reported in 26% of the vaccine group and 18.8% of the observation group.
Researchers conducted an additional post-hoc analysis to account for important clinical risk factors. The adjusted hazard ratio was 0.47, with a P-value of 0.0086.
This suggested a more favorable treatment effect after adjustment. However, the analysis was exploratory and cannot replace the unsuccessful primary trial result. (George et al., 2026)
Which Patients Showed Better Results?
Researchers examined whether certain patient characteristics influenced treatment outcomes.
Patients with negative ctDNA
Patients without detectable circulating tumor DNA at baseline showed encouraging results.
The median disease-free survival was not reached in the vaccine group, compared with 21.2 months in the observation group.
At 18 months, approximately 70% of vaccine recipients remained free from recurrence or death, compared with 56% in the observation group.
The hazard ratio was 0.51.
Patients with positive ctDNA
The researchers also examined patients who had detectable ctDNA.
The median disease-free survival was 4.3 months in the vaccine group and 1.9 months in the observation group. The hazard ratio was 0.57.
However, this subgroup included only 26 patients, with just six in the observation group. The findings therefore require further confirmation.
Patients without previous radiation
Another analysis examined patients who had not received radiation treatment before entering the study.
Their median disease-free survival was 23.8 months with camupepimut, compared with 10.4 months in the observation group. The hazard ratio was 0.59.
Researchers also found that patients with previous radiation had lower baseline lymphocyte counts and weaker vaccine-induced T-cell responses.
This suggests that previous treatment and immune cell levels may influence vaccine activity. However, the findings do not establish that radiation directly causes reduced vaccine effectiveness.
These subgroup findings are encouraging, but they should be interpreted cautiously because they do not replace the primary study outcome. (George et al., 2026)
Strong Immune Responses Observed
One of the most notable findings was the vaccine’s ability to activate T cells against mutated KRAS proteins.
Among the 90 vaccine-treated patients who could be evaluated for immune responses, 89 developed increased KRAS-specific T-cell activity. This represented 98.9% of evaluable patients.
The research also found that:
- 82.2% developed an immune response exceeding 9.17 times their baseline level.
- 87.6% developed responses against their own tumor-specific KRAS mutation.
- 95.5% of evaluable patients maintained a positive KRAS-specific T-cell response at 46 weeks or later.
Researchers also observed antigen spreading in 13 of 15 evaluated patients.
Antigen spreading occurs when the immune response expands beyond its original target to recognize additional tumor-related antigens. This could help the immune system recognize a wider range of cancer cells.
Patients with stronger vaccine-induced T-cell responses also showed better disease-free survival within the treated group. However, this was an exploratory association and does not prove that stronger immune activation directly caused longer survival.
These findings provide important evidence that the vaccine can activate broad and persistent immune responses against cancer-related targets. (George et al., 2026)
Safety and Study Limitations
The vaccine showed a generally favorable safety profile during the Phase 2 trial.
Grade 3 or higher adverse events occurred in 10.4% of patients receiving camupepimut, compared with 14.6% in the observation group.
Serious adverse events were reported in 6.3% of vaccine recipients and 8.3% of patients in the observation group.
The researchers also reported that no adverse events led to withdrawal from the study medication or death.
Despite these findings, several limitations remain important.
The study included only 144 patients and was open-label, meaning participants and investigators knew which treatment group patients entered.
Several subgroup and exploratory analyses were not adjusted for multiple statistical comparisons. These findings therefore need prospective confirmation.
The follow-up period was also relatively short. Overall survival data remain immature, and patients in the observation group were allowed to receive active treatment after disease progression, which may complicate future survival comparisons.
The researchers also noted that the study population was predominantly White and was limited to US centers, which may affect how broadly the findings apply to other populations. (George et al., 2026)
What Happens Next?
The AMPLIFY-7P results will help guide the development of a confirmatory Phase 3 clinical trial.
Researchers are considering ways to improve patient selection, optimize vaccine dosing and investigate whether longer treatment could maintain immune activity.
Future research may also examine combinations with immune checkpoint inhibitors and other treatments targeting the KRAS pathway.
These approaches remain under investigation. Larger clinical trials will be needed to determine whether they improve disease-free or overall survival.
The Phase 2 findings provide a useful foundation for further research, but camupepimut has not yet established itself as an approved treatment for pancreatic cancer.
Conclusion
The experimental pancreatic cancer vaccine camupepimut has demonstrated strong immune activity against mutated KRAS proteins in the Phase 2 AMPLIFY-7P trial.
Almost 99% of evaluable vaccine recipients developed KRAS-specific T-cell responses, and several patient subgroups showed encouraging disease-free survival results.
However, the study failed to meet its primary disease-free survival endpoint in the overall population. The favorable adjusted and subgroup findings require confirmation through larger clinical studies.
The upcoming Phase 3 research will be important in determining whether these immune responses can translate into meaningful long-term benefits for people living with pancreatic cancer.
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