UPDATE 1-Elicio shares slide after pancreatic cancer vaccine falls short in mid-stage study

Merck & Co., Inc.
Elicio Therapeutics, Inc
Moderna

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Elicio Therapeutics, Inc

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Shares plunge 72% after the data

Higher residual-disease imbalance in treated patients may have weighed on results, Elicio says

Company explores financing and partnership options for further development

Changes media packaging code to ELICIO-STOCKS from ELICIO-TRIAL/, updates share movement, adds analyst comment in paragraphs 5, 6 and 8

By Sahil Pandey and Mariam Sunny

- Elicio Therapeutics ELTX.O shares fell about 72% on Monday after the biotech firm's experimental pancreatic cancer vaccine failed to significantly extend the time patients lived without their disease returning, missing the main goal of a mid-stage study.

The therapy, ELI-002 7P, is designed to deliver the treatment directly to the lymph nodes to boost immune responses against the cancer.

The study enrolled 144 patients with pancreatic cancer linked to mutations in the KRAS gene, who had undergone surgery and standard treatment and were radiographically free of disease at enrolment, the company said.

Elicio said about 19% of patients who received the treatment had higher levels of residual disease, increasing the risk of relapse, compared with about 10% in the control group, an imbalance the company said weighed on results.

The trial carried the burden of generating the first randomized efficacy data for a KRAS‑targeted cancer vaccine and its broad enrolment, regardless of residual disease, "may have blunted the detectable treatment effect," B. Riley analyst Mayank Mamtani said.

He added that the "go-forward case" now rests on the late-stage study, which focuses on the patients with lower residual disease and evaluating additional dosing.

Moderna MRNA.O is developing a personalized cancer vaccine, intismeran autogene, in combination with Merck's MRK.N blockbuster drug Keytruda in patients with skin cancer.

Unlike personalized treatments that must be custom-made for each patient, ELI-002 7P is ready to use, which simplifies manufacturing and reduces cost, Mamtani said.

In patients with complete surgical clearance of cancer, representing about 84% of the study population, the therapy achieved an average disease-free survival of 23.8 months versus 12.8 months for control arm, which received only the standard-of-care, Elicio said.

The therapy also showed a favorable safety profile, with no treatment-related discontinuations and fewer adverse events than the control arm, supporting potential long-term use and combination approaches, Elicio said.

Elicio said it is currently evaluating multiple strategic financing and partnership opportunities.