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Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis

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time6 days ago

  • Business
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Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis

The AMPLIFY-7P study of ELI-002 7P successfully passes event-driven interim analysis for efficacy, futility, and safety by the IDMC The Company views the IDMC's positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy Final disease-free survival analysis is anticipated to occur in Q4 2025 Elicio previously reached alignment with the FDA on key elements of the planned pivotal Phase 3 study design The Company's current cash runway extends into Q1 2026, past the anticipated final DFS analysis BOSTON, Aug. 05, 2025 (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 announced that following the Independent Data Monitoring Committee's ('IDMC') pre-specified interim review of the unblinded safety and efficacy data in the Company's Phase 2 AMPLIFY-7P study in mutant KRAS ('mKRAS')-driven pancreatic ductal adenocarcinoma ('PDAC'), the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. 'We are encouraged by the IDMC's recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy. We look forward to the final disease-free survival ('DFS') analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients facing PDAC in the adjuvant setting,' said Robert Connelly, Chief Executive Officer of Elicio. 'Importantly, we previously reached alignment with the U.S. Food and Drug Administration ('FDA') on the key elements of the planned pivotal Phase 3 study design, and, upon final DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study.' The AMPLIFY-7P trial is a 2:1 randomized, open-label, multicenter clinical trial that enrolled 144 patients at 24 U.S. sites to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to standard of care ('SOC') (observation) to improve DFS in patients with PDAC in the adjuvant setting post local therapy, following surgery, chemotherapy, with or without radiation. Currently, the SOC in this setting is to conduct serial imaging scans to monitor closely for cancer progression. ELI-002 7P treatment consists of six doses, followed by an observation period of eight weeks, and followed with four additional booster doses. PDAC is an aggressive cancer with a five-year survival rate of 13% and is projected to become the second leading cause of cancer death in the U.S. by 2030. ELI-002 7P is an investigational, off-the-shelf, immunotherapy vaccine administered by subcutaneous injection targeting seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors. The Company remains blinded to the trial clinical efficacy outcomes. Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio's Amphiphile ('AMP') technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio's ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized vaccines approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer ('CRC') in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio's pipeline includes additional off-the-shelf therapeutic cancer vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit About ELI-002 Elicio's lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio's AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. About the Amphiphile Platform Elicio's proprietary AMP platform delivers investigational immunotherapeutics directly to the 'brain center' of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies. Elicio's AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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 the sufficiency of Elicio's existing cash and cash equivalents to support operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 final DFS analysis expected in the fourth quarter of 2025; Elicio's planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial anticipated in the fourth quarter of 2025; the potential efficacy of Elicio's product candidates, including ELI-002 7P; the potential of Elicio's product candidates, including ELI-002, to offer a new solution to patients facing PDAC in the adjuvant setting; Elicio's plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; the potential benefits and effectiveness of off-the-shelf vaccine approaches; 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 financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio's ability to continue as a going concern; Elicio's plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio's planned clinical trials; the timing of the availability of data from Elicio's clinical trials, including the final DFS analysis from the Phase 2 AMPLIFY-7P trial expected in the fourth quarter of 2025; the timing of any planned investigational new drug application or new drug application; Elicio's plans to research, develop and commercialize its current and future product candidates; and Elicio's estimates regarding future revenue, expenses, capital requirements and need for additional financing. 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 under the heading 'Risk Factors' in Elicio's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC filed with the SEC on May 13, 2025, as updated by subsequent 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. Investor Relations ContactBrian RitchieLifeSci Advisors(212) 915-2578britchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Unlocking Oncology's Future: 3 Trending Cancer Biotech Stocks with ‘Strong Buy' Ratings
Unlocking Oncology's Future: 3 Trending Cancer Biotech Stocks with ‘Strong Buy' Ratings

Yahoo

time28-07-2025

  • Business
  • Yahoo

Unlocking Oncology's Future: 3 Trending Cancer Biotech Stocks with ‘Strong Buy' Ratings

Cancer remains one of the most relentless challenges in modern medicine. In 2025, over 2 million new cancer cases are expected to be diagnosed in the United States. More than 618,000 people will die from the disease, which is equivalent to about 1,700 deaths each day. The scale of this health crisis is driving substantial investments and innovation in cancer research and treatment. As a result, the global oncology market is projected to reach $208.9 billion in revenue by 2025, with forecasts suggesting it could surpass $900 billion by 2034. This growth is fueled by increased cancer incidence, advances in precision and immunotherapy drugs, and billions of dollars in new partnerships and funding, such as Bristol-Myers Squibb's (BMY) recent $11 billion stake in next-generation cancer therapies. More News from Barchart Warren Buffett Warns Inflation Turns Business Into 'The Upside-Down World of Alice in Wonderland' But Weeds Out 'Bad Businesses' Why GOOGL Stock May Be the Market's Next Big Winner Alphabet Posts Lower Free Cash Flow and FCF Margins - Is GOOGL Stock Overvalued? Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. High-potential cancer specialists like Elicio Therapeutics (ELTX), Cellectis (CLLS), and Autolus Therapeutics (AUTL) are earning coveted 'Strong Buy' analyst ratings. Despite this recognition, each remains well below large-cap valuations, which leaves ample room for sharp upside if upcoming clinical and regulatory catalysts play out in their favor. Could one of these under-the-radar biotech firms deliver the next big breakthrough in cancer treatment — and major upside for investors? Let's dive into these three cancer biotech stocks now. Elicio Therapeutics Elicio Therapeutics (ELTX) is a clinical-stage biotech pioneering immunotherapies for solid tumors, with a market capitalization of $158 million. ELTX has posted a YTD gain of 92.7%, and is up 102.6% over the past 52 weeks. Its price-book ratio stands at an elevated 17.6x, well above the sector median of 2.47x. Elicio's lead asset, ELI-002 7P, is advancing through the pivotal Phase 2 AMPLIFY-7P trial targeting pancreatic ductal adenocarcinoma (PDAC), with a critical interim analysis focused on disease-free survival slated for Q3 2025. This interim analysis is a key milestone for the company, particularly for its potential impact on PDAC. Ahead of this readout, H.C. Wainwright analyst Robert Burns reiterated a 'Buy' rating on shares and maintained his $13 price target. Elicio reported Q1 2025 R&D expenses of $7.8 million, a slight increase from $7.6 million in Q1 2024, tied primarily to the ongoing Phase 2 AMPLIFY-7P trial. General and administrative expenses grew to $3 million, up from $2.7 million due to higher personnel costs. The Q1 2025 net loss narrowed to $11.2 million, compared to $11.8 million in the same quarter last year, with a net loss per share improving to $0.87 from $1.15. Notably, ELTX augmented its financial position in Q2 by securing a $10 million senior secured note, extending its operational runway into early 2026 and granting the company flexibility for near-term initiatives. Analyst sentiment skews highly bullish as the two surveyed analysts assign ELTX a 'Strong Buy' rating, with an average price target of $12.50. This places the upside potential at approximately 26% from current levels. Cellectis Cellectis (CLLS) is a clinical-stage biotech company specializing in gene-edited cell therapies with a market capitalization of approximately $140 million. The stock has gained 60% in the year to date, and shares are up 25.2% in the past 52 weeks. Cellectis has a price-sales ratio of 2.26x, below the sector median of 3.6x, and a price-book ratio of 0.96x, significantly under the sector median of 2.47x, suggesting potential undervaluation relative to its peers. CLLS reported solid results for Q1 2025, with consolidated revenues and other income rising to $12 million from $6.5 million a year prior. This increase mainly stems from $5.9 million recognized under the AstraZeneca Joint Research Collaboration Agreement (AZ JRCA). Its cash reserves stood at $246 million as of March 31, 2025, projected to sustain operations well into the second half of 2027, providing ample runway for ongoing development. Research and development expenses slightly decreased to $21.9 million compared to the previous year, reflecting efficient management despite continued investment in pipeline advancement and manufacturing capabilities in Paris and Raleigh. Strategically, Cellectis' partnership with AstraZeneca is a cornerstone of its growth story. AstraZeneca's $140 million investment enhances Cellectis' financial footing and grants AstraZeneca exclusive rights to 25 genetic targets, with options to develop up to 10 candidate products. So far this collaboration is advancing two CAR-T programs aimed at hematological malignancies and solid tumors. Analyst sentiment is unanimously bullish, with the five surveyed analysts assigning Cellectis a consensus 'Strong Buy' rating. The average price target of $5.60 implies compelling upside of approximately 91% from the current share price. Autolus Therapeutics Autolus Therapeutics (AUTL) develops advanced autologous CAR-T cell therapies for blood cancers, with a market capitalization of $670 million. The stock is up 8.7% year-to-date, but down 45% over the past 52 weeks. Its price-sales ratio of 69.4xx is markedly above the sector's 3.54x median, while its 1.89x price-book ratio remains below group averages of 2.47x. In Q1 2025, Autolus reported $9 million in net product revenue, driven largely by the commercial rollout of AUCATZYL (Obe-cel), its lead CAR-T therapy, across 39 fully activated U.S. centers. Patient access continues to grow, capturing coverage for roughly 90% of U.S. medical lives as payer uptake accelerates. Costs of sales totaled $18 million, including delivered but as-yet-unrecognized product tied to deferred revenue and royalty obligations, a natural part of early stage commercial launches. Research and development expenses dropped to $26.7 million from $30.7 million year-over-year, with much of that shift driven by the transition of manufacturing expenses to sales costs. Loss from operations widened to $65.2 million due to launch investments, and net loss reached $70.2 million or $0.26 per share. On the regulatory front, Autolus scored a critical win in July as AUCATZYL secured European approval for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This unlocks a larger addressable market and enhances the company's global competitive position in engineered cell therapies. The analyst outlook remains unequivocally positive as the nine surveyed analysts rate AUTL a consensus 'Strong Buy,' with a mean target of $9.84, implying 285% upside potential from current levels. Conclusion With major catalysts ahead and strong analyst backing, the odds favor upward momentum as data readouts and commercial expansion play out. Given their positioning and partnerships, these three stocks could deliver outsized gains in the coming quarters, especially if results come in strong. On the date of publication, Ebube Jones did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on

Elicio Therapeutics: Q1 Earnings Snapshot
Elicio Therapeutics: Q1 Earnings Snapshot

Yahoo

time13-05-2025

  • Business
  • Yahoo

Elicio Therapeutics: Q1 Earnings Snapshot

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Tuesday reported a loss of $11.2 million in its first quarter. The Boston-based company said it had a loss of 87 cents per share. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on ELTX at Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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