Elicio Therapeutics (ELTX) Corporate presentation summary

Clinical observations and outcomes

• Multiple confirmed complete responses observed in metastatic PDAC patients treated with ELI-002 7P followed by nivolumab-based therapy, with 100% of three patients achieving complete radiographic and metabolic responses and biomarker normalization.

• Complete responses were durable, with two of three patients maintaining responses for at least nine months, including one ongoing response.

• All three patients had MSS/MMR-proficient disease, a group rarely responsive to checkpoint inhibition, making these results notable compared to historical data.

• Historical studies show complete response rates of 0-8% with standard regimens, highlighting the rarity of such outcomes in metastatic PDAC.

• Observations support further evaluation of ELI-002 7P in combination with checkpoint inhibition in metastatic mKRAS pancreatic cancer.

Translational and mechanistic insights

• ELI-002 7P treatment associated with expansion and persistence of mKRAS-specific CD4+ and CD8+ T cell responses, including polyfunctional cytokine production.

• Increased T cell infiltration and modulation of tumor PD-L1 observed in tumor samples after ELI-002 7P, prior to subsequent therapy.

• Complete responses correlated with antigen spreading and broader anti-tumor immune responses beyond targeted KRAS mutations.

• Hypothesized mechanism suggests ELI-002 7P primes durable mKRAS-specific immunity, enhancing responsiveness to subsequent therapies such as checkpoint inhibitors.

Development strategy and next steps

• A focused Phase 1 study is planned to evaluate ELI-002 7P in combination with checkpoint inhibition in both recurrent and treatment-naïve metastatic PDAC.

• Study will use a triplet regimen (ELI-002 7P, SOC chemotherapy, checkpoint inhibitor) with primary endpoints including overall response rate, complete response rate, duration of response, and safety.

• Early efficacy signals and biomarker responses expected within 3-6 months, with small cohorts designed for capital efficiency.

• Next steps include finalizing study design, initiating the Phase 1 trial (pending funding), and informing future metastatic and adjuvant Phase 3 development.