Delaware
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001-39990
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11-3430072
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(State or other jurisdiction of incorporation or organization)
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(Commission File Number)
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(IRS Employer Identification No.)
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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(Title of each class)
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(Trading Symbol)
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(Name of exchange on which registered)
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Common Stock, $0.01 par value per share |
ELTX
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The Nasdaq Global Select Market |
Item 8.01 |
Other Events.
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Item 9.01. |
Financial Statements and Exhibits.
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(d) |
Exhibits.
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Exhibit
Number
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Exhibit
Description
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Press Release of Elicio Therapeutics, Inc., dated January 9, 2024
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Corporate presentation dated January 9, 2024
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Elicio Therapeutics, Inc.
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By:
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/s/ ROBERT CONNELLY
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Robert Connelly
President and Chief Executive Officer
(Principal Executive Officer)
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Date: January 9, 2024
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Data showed ELI-002 administered as a monotherapy induced robust, polyfunctional
and durable KRAS specific CD4+ and CD8+ T cell responses
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Tumor biomarker reduction was observed in 84% of patients correlating with a median relapse-free survival of 16.3 months
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Phase 2 trial of ELI-002 monotherapy in pancreatic ductal adenocarcinoma (“PDAC”) planned to initiate in early 2024
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The data is as of September 6, 2023, based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional
treatment.
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Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and
CD8+).
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Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3
pancreatic, 3 colorectal).
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At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months.
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Efficacy correlated with T cell response (≥ versus < median: 12.75-fold over baseline):
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Median tumor biomarker reduction was -76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014).
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Median RFS was not reached compared to 4.01 months in above versus below median T cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63, p=0.0167).
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Patients with greater than median T cell response had an 86% reduction in the risk of progression or death.
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The association of RFS with T cell response was not correlated to baseline prognostic variables including tumor stage, recovery from prior cytotoxic therapy as assessed by
absolute neutrophil count or immune system subsets such as %CD4+ or %CD8+ of CD3+ lymphocytes.
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RFS was shorter in patients who began treatment with a low absolute lymphocyte count.
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No safety concerns were identified, and no dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed.
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