Welcome to our dedicated page for Elicio Therapeutics news (Ticker: ELTX), a resource for investors and traders seeking the latest updates and insights on Elicio Therapeutics stock.
About Elicio Therapeutics, Inc.
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company pioneering the development of novel immunotherapies designed to prevent cancer recurrence and improve patient outcomes. Leveraging its proprietary Amphiphile (AMP) platform, Elicio delivers therapeutic payloads directly to the lymph nodes, the central hub of the immune response, to enhance the precision, magnitude, and durability of cancer-specific immune activation. This innovative approach positions Elicio at the forefront of the cancer immunotherapy sector, addressing significant unmet needs in the treatment of aggressive cancers.
Core Technology: The Amphiphile (AMP) Platform
Elicio’s AMP technology is engineered to optimize the immune system’s ability to recognize and eliminate cancer cells. By targeting the lymph nodes, the platform facilitates the efficient delivery of antigens, adjuvants, and immunomodulators, amplifying the immune response against tumor-specific mutations. This lymph node-specific engagement is designed to overcome limitations of conventional immunotherapies, offering potential advantages in magnitude, quality, and durability of immune responses. The AMP platform’s versatility allows for broad applicability across various cancer types and therapeutic modalities.
Pipeline and Key Programs
Elicio’s lead candidate, ELI-002, is an off-the-shelf cancer vaccine targeting KRAS mutations, which are implicated in approximately 25% of all solid tumors. ELI-002 is currently being evaluated in the AMPLIFY-7P Phase 1/2 clinical trial, focusing on patients with KRAS-driven pancreatic and colorectal cancers. The vaccine’s seven-peptide formulation is designed to provide immune coverage against multiple KRAS mutations, enhancing its therapeutic potential and patient eligibility. Early clinical data have demonstrated a favorable safety profile, robust T-cell responses, and promising disease-free survival (DFS) outcomes. Additional pipeline candidates, including ELI-007 and ELI-008, target BRAF-driven cancers and p53 hotspot mutations, respectively, further expanding Elicio’s portfolio of innovative immunotherapies.
Market Position and Competitive Differentiation
Operating within the highly competitive biotechnology sector, Elicio distinguishes itself through its groundbreaking AMP platform and focus on high-prevalence, hard-to-treat cancers. The company’s approach to targeting the lymph nodes for immune system activation represents a paradigm shift in cancer immunotherapy, offering potential advantages over traditional methods. By addressing biologically validated but challenging-to-drug targets, Elicio aims to redefine the standard of care for patients with limited treatment options.
Challenges and Opportunities
As a clinical-stage company, Elicio faces challenges common to the biotechnology industry, including regulatory approval processes, competition from other immunotherapy developers, and the inherent risks of clinical trials. However, the company’s innovative technology, promising early clinical data, and focus on high-impact therapeutic areas position it as a compelling player in the field. The potential for partnerships, licensing opportunities, and eventual commercialization of its pipeline products underscores significant growth prospects.
Conclusion
Elicio Therapeutics exemplifies scientific innovation and commitment to addressing unmet medical needs in oncology. Through its AMP platform and robust pipeline, the company is poised to make meaningful contributions to the fight against cancer, offering hope to patients and families impacted by these devastating diseases.
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.
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