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Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company focused on transforming cancer treatment through cutting-edge immunotherapies. By leveraging its proprietary Amphiphile (AMP) platform, Elicio is developing vaccines and immunotherapies targeting aggressive cancers such as pancreatic, colorectal, and head and neck cancers.
The AMP platform uniquely targets and delivers immunogens directly to the lymphatic system, amplifying the body's immune response to fight cancer and prevent its recurrence. This innovative approach aims to unlock the full potential of the human immune system, resulting in enhanced anti-tumor functionality and long-term protective memory.
Recent achievements include:
- The commencement of initial patient studies for its lead amphiphile vaccines targeting various cancers in early 2020.
- Ongoing Phase 1 and Phase 2 trials for ELI-002, a novel cancer vaccine targeting mutant KRAS-driven tumors.
- The publication of promising preclinical and clinical data which demonstrate the AMP platform's potential in enhancing T cell responses and eradicating solid tumors.
Financial updates reveal continued investment in clinical trials and research, with expenses reflecting the company's robust R&D initiatives. Partnerships with renowned institutions like the University of Texas MD Anderson Cancer Center further bolster Elicio's research capabilities.
Looking forward, Elicio plans to advance its development pipeline, including the ELI-002 7P Phase 2 trial as a monotherapy for patients with pancreatic ductal adenocarcinoma (PDAC). The company remains committed to pioneering new cancer treatments and improving patient outcomes.
Elicio Therapeutics (Nasdaq: ELTX) has announced a $10.0 million registered direct offering priced at-the-market under Nasdaq rules. The offering includes 1,261,830 shares of common stock and accompanying warrants to purchase an equal number of shares at a purchase price of $7.925 per share and warrant.
The warrants will have an exercise price of $7.80 per share, will be immediately exercisable upon issuance, and will expire after five years. The offering is expected to close around January 30, 2025, with H.C. Wainwright & Co. acting as the exclusive placement agent.
The company plans to use the net proceeds for working capital and general corporate purposes. The offering is being made through an effective shelf registration statement filed with the SEC.
Elicio Therapeutics (ELTX) has received supportive FDA feedback regarding the registrational strategy for its cancer immunotherapy candidate ELI-002. The FDA alignment covers key elements of the potential Phase 3 study design, including dose, schedule, patient population (KRAS-mutated pancreatic adenocarcinoma), and primary endpoint analysis of disease-free survival.
The company's Phase 2 randomized study of ELI-002 is fully enrolled, with a formal interim analysis of disease-free survival expected in H1 2025. Positive results could support rapid advancement into Phase 3 development. The therapy has shown encouraging clinical results with a favorable safety profile and strong correlation between T cell response, tumor biomarker reductions, and reduced risk of recurrence or death.
ELI-002 is being developed as an off-the-shelf monotherapy for patients who completed chemotherapy but remain at elevated risk of disease recurrence.
Elicio Therapeutics (ELTX) presented updated Phase 1 AMPLIFY-201 trial results for ELI-002, their cancer vaccine targeting KRAS-mutant tumors. With 19.7 months median follow-up, the study showed 16.3-month median recurrence-free survival (mRFS) and 28.9-month median overall survival (mOS) in the full study population of 25 patients with colorectal or pancreatic cancer.
The trial demonstrated strong correlation between T cell response and survival outcomes. Patients with above-median T cell responses hadn't reached mRFS, while those below median achieved 4.0-month mRFS. The vaccine showed favorable safety profile with no Grade 3/4 adverse events. ELI-002's seven-peptide formulation is currently in Phase 2 trials, with interim analysis expected in H1 2025.
Elicio Therapeutics has completed enrollment for its Phase 2 AMPLIFY-7P study, evaluating ELI-002 7P in patients with mKRAS-driven pancreatic ductal adenocarcinoma. The randomized trial enrolled 135 patients, exceeding enrollment speed expectations. Patients were randomized 2:1 to receive ELI-002 7P versus standard care observation, with crossover allowed upon disease progression. The study's primary endpoint is disease-free survival (DFS), with a formal interim analysis expected in H1 2025. The trial follows successful Phase 1a results that showed favorable safety profiles and robust T-cell responses.
Elicio Therapeutics (ELTX) reported Q3 2024 financial results and corporate updates. The company expects to complete enrollment in its AMPLIFY-7P Phase 2 randomized study in Q4 2024, with interim analysis expected in H1 2025. Q3 financial results showed R&D expenses of $7.2 million and G&A expenses of $3.1 million. Net loss was $18.8 million, with cash position of $26.0 million as of September 30, 2024. The company strengthened its financial position through an $11.5 million public offering and $20 million private placement of convertible notes, expecting to support operations into Q2 2025.
Elicio Therapeutics presented updated preliminary results from the AMPLIFY-7P Phase 1 clinical trial of ELI-002, an Amphiphile cancer vaccine targeting KRAS-mutant tumors. Key findings show mKRAS-specific T cell responses in all evaluable patients, with the 4.9 mg dose group showing 12-fold higher response than the 1.4 mg group. The magnitude of T cell response correlated with disease-free survival (DFS). T cell responses were durable up to 1.5 years, with antigen spreading detected in 100% of RP2D-treated patients. The vaccine remains safe and well-tolerated, with Phase 2 interim DFS analysis expected in H1 2025.
Elicio Therapeutics (Nasdaq: ELTX) announced two upcoming presentations in November 2024. At the SITC 39th Annual Meeting (Nov 6-10), they will present updated T cell and Disease-Free Survival data from the AMPLIFY-7P Phase 1 trial of ELI-002, an Amphiphile cancer vaccine targeting KRAS-mutant tumors. The Phase 2 portion of this trial is ongoing with enrollment expected to complete in Q4 2024. Additionally, at the Stand Up To Cancer Innovation Summit (Nov 4), Dr. Peter Demuth will present updates on the AMP platform and data from both AMPLIFY-7P and AMPLIFY-201 Phase 1 trials.
Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company focused on developing novel cancer immunotherapies, has announced the granting of inducement stock options to two new employees. The grants, approved by the Compensation Committee of Elicio's Board of Directors, were made under the company's 2024 Inducement Incentive Award Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The details of the grants are as follows:
- Total options granted: 5,900
- Grant date: October 15, 2024
- Exercise price: $4.49 per share (closing price on grant date)
- Vesting schedule: 25% after one year, remainder vesting monthly over the following three years
These stock options serve as an inducement for the new employees joining Elicio Therapeutics and are subject to their continued employment with the company.
Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotech company focused on cancer immunotherapies, has announced the granting of 4,800 inducement stock options to a new employee. This grant, approved by the Compensation Committee of Elicio's Board of Directors, was made under the company's 2024 Inducement Incentive Award Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The stock options allow for the purchase of Elicio common stock at $4.13 per share, which was the closing price on September 16, 2024, the date of grant. The options have a four-year vesting schedule, with 25% vesting on the first anniversary of the employee's start date and the remainder vesting monthly thereafter, contingent on continued employment with Elicio.
Elicio Therapeutics (Nasdaq: ELTX) announced three upcoming presentations focusing on its lymph node targeted, mKRAS-specific Amphiphile vaccines. The presentations will take place at:
1. AACR Special Conference (Sept 15-18, 2024, Boston): Dr. Eileen O'Reilly will present Phase I AMPLIFY-7P trial updates.
2. RAS-Targeted Drug Development Summit (Sept 25, 2024, Boston): Dr. Pete DeMuth will discuss clinical translation of Elicio's RAS-targeted Amphiphile vaccines.
3. Stuart and Molly Sloan Precision Oncology Institute Symposium (Oct 1, 2024, Seattle): Dr. Christopher Haqq will present Phase I experience with ELI-002 2P and ELI-002 7P.
CEO Robert Connelly highlighted recent data showing T cell response correlation with reduced tumor biomarkers and progression risk. Elicio's $43 million funding is expected to provide runway into Q2 2025, with clinical updates expected in Q4 2024 and Q1 2025.