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4週前
Elicio Therapeutics Shares Plunge After Pancreatic Cancer Study Misses Main Goal (ELTX)June 15, 2026 9:45 AM
IH Market News Elicio Therapeutics Inc. (NASDAQ:ELTX) shares tumbled 47% on Monday after the company announced that its Phase 2 AMPLIFY-7P trial of ELI-002 7P in pancreatic cancer failed to achieve its primary endpoint of disease-free survival in the intent-to-treat population. The study assessed ELI-002 7P against observation in patients with resected Stage I-III mutant KRAS-driven pancreatic ductal adenocarcinoma who had previously undergone surgery and standard locoregional treatment. Baseline Imbalance Cited as Key Factor Although the trial did not meet its main objective, Elicio said the results were affected by differences in baseline patient characteristics between the treatment and control groups. According to the company, 19% of patients receiving ELI-002 7P had R1 resection status, compared with 10% in the observation arm. R1 resection status is recognised as a negative prognostic factor associated with a higher risk of disease recurrence. Management believes this imbalance had a meaningful impact on the overall study outcome. Post-Hoc Analysis Shows Benefit in Fully Resected Patients A post-hoc review of patients who achieved complete tumour resection (R0), representing approximately 84% of trial participants, produced more encouraging findings. Within this subgroup, ELI-002 7P generated a hazard ratio of 0.65 (p=0.048), with median disease-free survival reaching 23.8 months compared with 12.8 months for patients under observation. Additional landmark analyses showed an absolute disease-free survival advantage of 14% at both the three-month and six-month marks during active treatment. Immune Response Linked to Improved Outcomes The trial also demonstrated a connection between mutant KRAS-specific T-cell responses and disease-free survival. Patients who generated the strongest immune responses experienced a hazard ratio of 0.22, suggesting substantially improved outcomes compared with weaker responders. Elicio noted that ELI-002 7P maintained a favourable safety profile throughout the study, with no treatment-related deaths or discontinuations reported. Company Plans Refined Phase 3 Programme Based on the findings, Elicio intends to pursue a revised Phase 3 development strategy focused on patients with R0 resections. The proposed approach includes additional dosing beyond the initial vaccination and booster schedule used in the Phase 2 study, with the aim of improving long-term efficacy. Cash Runway Extends Into Late 2026 The company said its current cash and cash equivalents are expected to fund operations into the fourth quarter of 2026. Elicio is also exploring a range of strategic financing alternatives and potential partnership opportunities as it advances development plans for ELI-002 7P and its broader oncology pipeline. Elicio Therapeutics stock price Original: Elicio Therapeutics Shares Plunge After Pancreatic Cancer Study Misses Main Goal (ELTX)
axelvento
4月前
March 12, 2026 16:05 ET
Event-driven primary disease-free survival (“DFS”) analysis for Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”) is anticipated in 1H 2026
Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial
The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes.
Projected cash runway into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 DFS analysis in 1H 2026
BOSTON, March 12, 2026 (GLOBE NEWSWIRE) — Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the year ended December 31, 2025, and provided recent corporate and clinical updates.
“In 2025, we made meaningful progress advancing ELI-002 7P in KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio. “We remain focused on completing the Phase 2 AMPLIFY-7P trial and reaching the event-driven primary DFS analysis expected in 1H 2026. We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P’s potential to favorably impact outcomes. With capital expected to carry us beyond the anticipated DFS readout, we believe we are well positioned to deliver this important milestone and continue advancing our Amphiphile (“AMP”) platform in KRAS-mutant PDAC. We remain highly interested in the potential to expand the development of ELI-002 7P to neoadjuvant and metastatic PDAC and other KRAS+ tumors, with the goal of creating meaningful long-term value for patients and shareholders.”
Recent Highlights
In 2025, Elicio continued advancement of the randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC, with the event-driven primary DFS analysis remaining on track for an anticipated 1H 2026 readout
In December 2025, Elicio reported evidence of antigen spreading to patient-specific neoantigens beyond mKRAS in the ongoing Phase 2 AMPLIFY-7P trial, demonstrating induction of de novo T cell responses against non-vaccine tumor neoantigens and further supporting the breadth and potential durability of the ELI-002 7P immune response in mKRAS-driven PDAC
In November 2025, Elicio appointed Marc J. Wolfgang as Chief Technology Officer, strengthening the Company’s chemistry, manufacturing, and controls and technical operations capabilities to support late-stage development and potential commercialization readiness
Upcoming Anticipated Milestones for the AMPLIFY-7P Phase 2 Trial
Oral presentation in the Targeted Immunotherapies section at the World Vaccine Congress Washington 2026 (March 30–April 2, 2026; Walter E. Washington Convention Center, Washington, D.C.), scheduled for Wednesday, April 1st at 12:40 PM ET, by Dr. Peter DeMuth, Chief Scientific Officer, highlighting the ELI-002 platform overview, updated Phase 1 2P data (safety, T-cell responses, correlations to tumor biomarkers, RFS and OS), Phase 1 7P data, and Phase 2 AMPLIFY-7P updates (T-cell responses, HLA association and antigen spreading)
ELI-002 to be highlighted by principal investigator Dr. Shubham Pant of The University of Texas MD Anderson Cancer Center (Houston, TX) during his pancreatic cancer presentation in the Advances in Pancreatic Cancer Research and Treatment session at the American Association for Cancer Research (“AACR”) Annual Meeting 2026 (April 17–22, 2026; San Diego, CA), scheduled for Tuesday, April 21st at 12:30 PT
Event-driven primary DFS analysis of the Phase 2 AMPLIFY-7P trial anticipated in 1H 2026
Plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC following completion of the primary DFS analysis
Finalize the Phase 3 protocol and advance ELI-002 7P toward initiation of a registrational study following the primary DFS endpoint analysis, subject to regulatory alignment.
Continued translational and immunologic data updates from the AMPLIFY 7P program, including additional analyses of antigen spreading and T-cell durability
2025 Financial Results
R&D expense for 2025 was $24.9 million, compared to $33.7 million for 2024. The decrease in R&D expense was primarily related to lower clinical costs as patients progressed into the observation phase of the Phase 2 study of ELI-002 7P.
G&A expense for 2025 was $12.8 million, compared to $11.3 million for 2024.
Net loss for 2025 was $39.5 million, compared to $51.9 million for 2024. Net loss for 2025 includes $1.9 million of non-cash other expense resulting from the change in fair value of the warrant liability. Net loss per share for 2025 was $2.58, compared to $4.25 for 2024.
Cash and cash equivalents as of December 31, 2025, were $18.6 million, compared to $17.6 million as of December 31, 2024.
The Company expects its current cash and cash equivalents and projected at-the-market program proceeds to support operations into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven DFS analysis expected in 1H 2026. The Company raised net proceeds of approximately $4.9 million in Q4 2025 and $6.3 million in Q1 2026 to date, through its established at-the-market program.
https://elicio.com/press_releases/elicio-therapeutics-reports-full-year-2025-financial-results-and-provides-corporate-updates/
axelvento
2年前
Elicio Therapeutics' Novel Approach
Founded in 2011, Elicio Therapeutics, Inc. ELTX is developing treatment options aimed at significantly improving the quality of life for cancer patients through the utilization of precision vaccines, immunomodulators and cell-based therapies to potentially assemble cancer-killing immune responses against solid tumors.
The company is optimistic about the potential of lymph node-targeting made possible by applying the natural trafficking pathways of larger molecules. This approach differentiates Elicio from its competitors and could be highly promising for enhancing anti-tumor immune responses and improving therapeutic efficacy.
Developed at the Massachusetts Institute of Technology (MIT), the company's proprietary Amphiphile or "AMP" platform, which combines expertise in materials science and immunology, is being used to develop novel immunotherapies, including cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases.
Here's how it works:
The AMP platform is designed to deliver therapeutic payloads directly to critical immune cells in the lymph nodes, enhancing the cancer-fighting mechanisms of the immune system. By delivering cancer immunotherapies to the center of the immune response, this approach is intended to optimize the natural ability of the lymph nodes to educate, activate and amplify cancer-specific T cells.
Engineered to coordinate immunity in these uniquely potent sites, the AMP platform was built to amplify the magnitude, potency, quality and durability of the immune response to drive antitumor activity.
At the injection site, the platform prevents detrimental payload delivery to systemic circulation, instead guiding the payloads into the lymphatics to promote lymph node delivery. Additionally, it preserves the structural integrity and activity of payloads by preventing any degradation prior to uptake by lymph node resident immune cells.
Upon reaching the lymph nodes, the platform optimizes retention and directs the delivery of payloads to key immune cells responsible for the coordination of immune responses, specifically the activation and amplification of cancer-specific immune cells in lymph nodes.
Overall, Elicio Therapeutics anticipates that the AMP platform could potentially provide a better quality of life to patients during treatment. The strategy is set apart from other treatments by its ability to activate immune mechanisms directly in the lymph nodes. Enhanced T cell infiltration into tumors, improved T cell expansion and persistence, potent anti-tumor T cell function and wide breadth of response are key attributes with the potential to improve efficacy and reduce the risk of resistance to therapy.
Moving forward, Elicio Therapeutics is committed to developing its lymph node-targeting approach for deployment across a range of vaccines, immunomodulators and adjuvants — training the immune system to put the best cells forward to fight a broad spectrum of cancers.
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