Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002
- None.
- None.
The emergence of ELI-002 as a monotherapy in the treatment of pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer represents a significant advancement in the field of oncology. The robust response rates observed in the Phase 1 trial, with 84% of patients exhibiting mKRAS-specific T cell responses, is particularly noteworthy given the historically challenging nature of treating these cancers. The presence of polyfunctional T cell responses, which involve both CD4+ helper cells and CD8+ killer cells, suggests a comprehensive immune activation that could potentially translate into more durable clinical benefits.
Furthermore, the correlation between T cell response and relapse-free survival (RFS) is a critical finding. Patients with higher T cell responses demonstrated a marked reduction in the risk of progression or death, which is an encouraging indicator of the vaccine's potential efficacy. The absence of severe adverse events underscores the treatment's safety profile, which is a crucial consideration for patient quality of life.
The data also highlight the importance of immune system status prior to treatment, as evidenced by shorter RFS in patients with low absolute lymphocyte counts. This suggests that patient selection and immunological profiling could play a role in optimizing treatment outcomes with ELI-002.
The clinical data for ELI-002 presented in Nature Medicine are compelling, especially when considering the median relapse-free survival of 16.3 months in a cohort with a substantial proportion of PDAC patients. PDAC is known for its aggressive nature and limited treatment options, making the observed RFS quite remarkable. The study's design, which included patients with minimal residual disease, positions ELI-002 as a potential adjuvant therapy that could significantly alter the treatment landscape for PDAC and colorectal cancer if these results are replicated in larger, randomized trials.
The use of tumor-informed circulating tumor DNA (ctDNA) as a biomarker for response is also significant. As a highly sensitive and specific tool for detecting minimal residual disease, ctDNA can provide an early indication of treatment efficacy and could serve as a surrogate endpoint in future trials, potentially accelerating the drug development process.
It is also worth noting the potential economic implications. If ELI-002 progresses favorably through Phase 2 trials and gains regulatory approval, it could represent a substantial market opportunity for Elicio Therapeutics. The demand for effective adjuvant therapies in PDAC is high and a successful treatment could command premium pricing.
The positive outcomes from the Phase 1 trial of ELI-002 have significant implications for Elicio Therapeutics' valuation and market potential. The data suggest a strong clinical benefit, which, if substantiated in Phase 2 trials, could position the company as a leader in targeted cancer immunotherapies. The specificity of ELI-002 in targeting mKRAS mutations, which are prevalent in a subset of cancer patients, allows for a tailored therapeutic approach that could command a significant market share in the precision medicine space.
From an investment perspective, the current data could lead to increased investor confidence and potentially drive up the company's stock price. However, investors should also consider the risks inherent in clinical development, including the possibility that subsequent trials may not replicate the Phase 1 results. Additionally, the competitive landscape, with other companies also pursuing KRAS-targeted therapies, will be an important factor in Elicio's long-term success.
Given the high unmet need in PDAC treatment, a successful market entry of ELI-002 could result in substantial revenue growth for Elicio. The lack of severe adverse events reported may also facilitate a smoother regulatory pathway and faster market adoption, pending trial outcomes. Stakeholders should monitor upcoming trial designs, patient enrollment and interim analyses for further investment insights.
- Data showed ELI-002 administered as a monotherapy induced robust, polyfunctional and durable KRAS specific CD4+ and CD8+ T cell responses
- Tumor biomarker reduction was observed in
84% of patients correlating with a median relapse-free survival of 16.3 months - Phase 2 trial of ELI-002 monotherapy in pancreatic ductal adenocarcinoma (“PDAC”) planned to initiate in early 2024
BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the publication of data from the Phase 1 (AMPLIFY-201) study of ELI-002 2P in Nature Medicine. The paper, “Lymph Node Targeted, mKRAS-specific Amphiphile Vaccine in Pancreatic and Colorectal Cancer: The phase 1 AMPLIFY-201 Trial”, details expanded and updated results originally presented at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting and the 2023 AACR Special Conference on Pancreatic Cancer.
“When tumor DNA or protein persists or recurs after treatment, patients with pancreatic and colorectal cancers are unfortunately not left with many options and are often incurable,” said study author Shubham Pant, M.D., Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “These are promising early findings from the AMPLIFY-201 study with follow up ongoing. Most patients reduced their tumor biomarkers with some having complete clearance following treatment with ELI-002.”
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, added, “Our lymph node-targeted cancer vaccine candidate induced direct ex vivo mKRAS-specific T cell responses in
Nature Medicine Publication Highlights
- 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.
- Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (
84% ;59% both CD4+ and CD8+). - 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). - At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months.
- Efficacy correlated with T cell response (≥ versus < median: 12.75-fold over baseline):
- Median tumor biomarker reduction was -
76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014). - 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). - Patients with greater than median T cell response had an
86% reduction in the risk of progression or death.
- Median tumor biomarker reduction was -
- 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.
- RFS was shorter in patients who began treatment with a low absolute lymphocyte count.
- No safety concerns were identified, and no dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed.
About ELI-002
ELI-002 is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by the ELI-002 7P formulation are present in
ELI-002 2P is currently being studied in a Phase 1 trial (“AMPLIFY-201”) in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 1/2 trial in patients with high relapse risk mKRAS-driven solid tumors (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.
About Elicio Therapeutics
Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (“AMP”) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers.
Cautionary Note on Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of the availability of data from Elicio’s clinical trials; Elicio’s plans to initiate a randomized phase 2 trial studying ELI-002 as a monotherapy in adjuvant PDAC patients early in 2024; and Elicio’s plans to research, develop and commercialize its current and future product candidates.
New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the current report on Form 8-K that was filed with the SEC on June 2, 2023 and Elicio’s periodic reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.
Media Contact
Kristin Politi
LifeSci Communications
kpoliti@lifescicomms.com
646-876-4783
Investor Relations Contact
Heather DiVecchia
Elicio Therapeutics
IR@elicio.com
857-209-0153
FAQ
What did Elicio Therapeutics announce?
What were the results of the Phase 1 study?
What is the plan for ELI-002 in pancreatic ductal adenocarcinoma?
