ELI-002

Funding expected to support operations into Q1 2026. Anticipated AMPLIFY-7P Phase 2 interim analysis expected in Q3 2025. BOSTON, June 04, 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 it has entered a $10 million senior secured promissory note (the “Note”) with existing investor, GKCC, LLC (“Note Holder” or “GKCC”) (the “Note Financing”). The proceeds from the Note Financing, together with Elicio’s current cash and cash equivalents, are expected to support Elicio’s operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis expected in the third quarter of 2025. The Company received gross proceeds of $10 million in the Note Financing. The Note bears an interest rate of up to 12.5%, and matures on June 3, 2028. It includes a 24-month interest-only period, and interest accrued during the first 12 months is payable in a lump sum beginning on the thirteenth month after closing. In connection with the Note Financing, the Company also issued the Note Holder warrants to purchase an aggregate of 103,225 shares of Elicio’s common stock with an exercise price of $7.75 per share. The warrants are immediately exercisable and will expire five years from the date of issuance. “This transaction immediately strengthens our balance sheet extending our cash runway into Q1 2026 and beyond the anticipated AMPLIFY-7P Phase 2 interim analysis in pancreatic ductal adenocarcinoma (“PDAC”) for ELI-002 in Q3 2025,” commented Robert Connelly, Chief Executive Officer of Elicio. “Importantly, this financing provides us with the flexibility to execute on multiple near-term key corporate and business development initiatives, and we are extremely pleased to have the ongoing support of a strong partner like GKCC.” “To this end, we are seeing robust interest from clinical investigators in potentially evaluating ELI-002 in combination regimens for PDAC and colorectal cancer, and we look forward to exploring these opportunities,” continued Mr. Connelly. “Based on the Phase 1 data generated to date, we believe ELI-002 represents a potentially transformative approach in the treatment of mKRAS-driven tumors, and view the upcoming randomized interim data readout in PDAC as a critical validating opportunity for our AMP platform.” 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 www.elicio.com. 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 current cash and cash equivalents to support operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis expected in the third quarter of 2025; expectations about Elicio’s financial and operating results, including Elicio’s ability to execute on multiple near-term future corporate and business development initiatives; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected interim analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates, including the potential transformational approach ELI-002 could represent in the treatment of mKRAS-driven tumors; the potential impact of ELI-002 in PDAC, including the potential for Elicio’s Phase 2 AMPLIFY-7P interim analysis to be a critical validating opportunity for Elicio’s AMP platform; 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 interim analysis from the Phase 2 AMPLIFY-7P trial expected in the third 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 in the Annual Report on Form 10-K filed with the SEC on March 31, 2025, under the heading “Risk Factors” and any 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 Contact Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com

随着免疫治疗的不断突破，癌症疫苗正逐步走向癌症治疗舞台的中心。这一疗法不仅有望成为传统手段难以奏效癌种的“破局者”，还能根据患者个体情况量身定制，为“个体化抗癌”提供强有力的支撑。目前，美国食品药品监督管理局（FDA）已批准多款癌症疫苗，以各自独特的机制显著改善了多类患者的预后。与此同时，更多新型癌症疫苗正在临床试验中展现希望，在延长患者生存期、降低复发风险方面持续释放潜力。为了更好地理解癌症疫苗在多种肿瘤类型中的应用价值，以及未来值得关注的重点疫苗项目，美国OncLive网站近期采访了多位肿瘤领域专家。本文将带来一手解读。癌症疫苗的未来极具前景美国MD安德森癌症中心胃肠道肿瘤内科教授Shubham Pant指出：“癌症疫苗正在成为癌症治疗的前沿。一个典型代表就是黑色素瘤疫苗，这种癌症对疫苗治疗非常敏感。我更关注的是在癌症早期阶段应用疫苗的可能性。比如在早期胰腺癌中，即使进行了手术切除和术后辅助治疗，患者依然面临高度复发风险。因此，研究人员正致力于开发能够靶向微转移病灶的疫苗，以延缓复发，甚至提升治愈率。”1已获批的多款癌症疫苗，为患者带来切实获益1.膀胱癌疫苗：卡介苗（BCG）蕞早获得美国食品药品监督管理局（FDA）批准的癌症疫苗，是卡介苗（BCG）。它源自减毒牛型分枝杆菌，蕞初为结核病疫苗，后因在肿瘤研究中展现疗效，于1990年获批用于非肌层浸润性膀胱癌（NMIBC）治疗，成为全球头一个获批的癌症免疫疗法。至今，卡介苗（BCG）仍是治疗非肌层浸润性膀胱癌（NMIBC）的标准方案，临床应用非常成熟。2.膀胱癌疫苗：Adstiladrin对于在接受卡介苗（BCG）治疗后病情仍进展的非肌层浸润性膀胱癌（NMIBC）患者，nadofaragene firadenovec-vncg（商品名：Adstiladrin）成为一种新的治疗选择。这是一种基因治疗型癌症疫苗。2022年12月，Adstiladrin获美国食品药品监督管理局（FDA）批准，用于治疗患有原位癌（伴或不伴乳头状肿瘤）的高风险、对卡介苗（BCG）治疗无反应的非肌层浸润性膀胱癌（NMIBC）成年患者。这也是头一个获得FDA批准的腺病毒载体基因疗法。支持其获批的3期临床研究CS-003（NCT02773849）显示，接受治疗的可评估患者中，有51%达到完全缓解（CR），即肿瘤完全消失；平均缓解持续时间（DOR）为9.7个月。目前，Adstiladrin正在3b期ABLE-32临床试验（NCT06510374）中，评估其在中等风险非肌层浸润性膀胱癌（NMIBC）患者中的疗效。美国南卡罗来纳州卡罗莱纳泌尿研究中心主任Neal D. Shore博士表示：“Adstiladrin是一种通过膀胱内灌注给药的治疗方式。它的独特之处在于，将‘干扰素α-2b’这一免疫活性蛋白装入改造后的病毒载体中。药物进入膀胱后，可刺激患者体内自行产生干扰素，激活免疫系统，促使癌细胞逐步走向凋亡。这是一种通过激活患者自身免疫力来清除癌细胞的新型疗法。”3.前列腺癌疫苗：Sipuleucel-T2010年4月，癌症疫苗 sipuleucel-T（商品名：Provenge）获得美国食品药品监督管理局（FDA）批准，用于治疗无症状或症状较轻的转移性去势抵抗性前列腺癌（mCRPC）患者。该疫苗的原理是：首先识别前列腺癌细胞上特有的“标志物”——前列腺酸性磷酸酶（PAP），然后利用患者自身免疫细胞进行激活，使其能识别并攻击表达PAP的癌细胞，从而达到治疗目的。4.黑色素瘤疫苗：T-VEC在黑色素瘤治疗中，基于溶瘤病毒的疫苗talimogene laherparepvec（T-VEC，商品名：Imlygic）于2015年10月获得美国食品药品监督管理局（FDA）批准，用于手术无法切除且术后复发的黑色素瘤患者的皮肤、皮下及淋巴结病灶的局部治疗。T-VEC由一种经过基因改造的单纯疱疹病毒1型构成，能在肿瘤细胞内复制并产生粒细胞-巨噬细胞集落刺激因子（GM-CSF），蕞终诱导癌细胞死亡。批准依据的是3期OPTiM研究（NCT00769704）的数据，研究结果显示：在无法切除的晚期黑色素瘤患者中，T-VEC在诱导癌症“持久缓解”方面表现显著优于单用GM-CSF。2更多新型癌症疫苗正加速推进中目前，多种新型癌症疫苗正在全球范围内加紧研发，适应症涵盖胰腺癌、结直肠癌、前列腺癌和肺癌等多个难治实体瘤领域。1.癌症疫苗ELI-002适应癌种：胰腺癌、结直肠癌等KRAS突变实体瘤研发公司：美国Elicio Therapeutics公司在1期AMPLIFY-201试验（NCT04853017）中，新型KRAS靶向癌症疫苗ELI-002正在接受评估，适用于已成功手术切除且携带KRAS G12D和G12R突变的胰腺导管腺癌（PDAC）或结直肠癌（CRC）患者。AMPLIFY-201试验数据显示，接受ELI-002（2肽配方）治疗的可评估患者，平均总生存期（OS）为28.9个月，平均无复发生存期（RFS）为16.3个月。其中：胰腺导管腺癌（PDAC）患者的平均总生存期（OS）为28.9个月，平均无复发生存期（RFS）为15.3个月。结直肠癌（CRC）患者的平均总生存期（OS）尚未达到（NR，意味着多数患者仍然存活，疗效持续观察中），平均无复发生存期（RFS）为16.3个月。Shubham Pant教授指出：“ELI-002对已切除或高风险患者可能带来重要改变。大多数胰腺癌患者本身就属于高风险人群，如果疫苗能有效清除微转移病灶，有望显著延迟复发，甚至提升治愈可能。”目前，一种7肽配方的ELI-002正在2期AMPLIFY-7P研究（NCT05726864）中接受评估，目标是治疗携带KRAS/NRAS突变的实体瘤患者。该研究的中期分析数据预计将于2025年上半年公布。2.癌症疫苗CAN-2409适应癌种：前列腺癌、肺癌、胰腺癌等研发公司：美国Candel Therapeutics公司另一种新型癌症疫苗aglatimagene besadenovec（CAN-2409）目前正在多个临床试验中接受评估。CAN-2409是一种“即用型”病毒基因免疫疗法，利用一种无法复制的腺病毒，它能够将一种叫做单纯疱疹病毒胸苷激酶（HSV-TK）的基因精准地送入肿瘤部位。这个基因进入肿瘤后，可以激发身体的免疫系统产生针对性的反应，从而帮助识别并攻击肿瘤细胞，实现个体化的抗癌效果。2024年12月，CAN-2409的研发商美国Candel Therapeutics公司宣布，3期PrTK03研究（NCT01436968）达到了主要终点——无病生存期（DFS，指患者接受治疗后，癌症没有复发或恶化的时间）。该研究比较了CAN-2409联合伐昔洛韦（Valtrex）和标准外照射放疗与单纯标准治疗，在新诊断的中高风险局部前列腺癌患者中的疗效。研究结果显示：在平均随访50.3个月时，意向治疗人群数据显示，接受CAN-2409联合治疗的患者，相比仅接受标准治疗的患者，复发或死亡风险降低了30%。在第54个月时，CAN-2409联合治疗组的无病生存率相较对照组提高了14.5%。此外，CAN-2409联合治疗组2年时的病理完全缓解率（pCR）为80.4%，意味着治疗后经过2年，有80.4%的患者肿瘤完全消失，病理检查中找不到癌细胞；对照组为63.6%。PrTK03研究的负责人、美国哈克萨克梅里迪安健康系统泌尿肿瘤学联合主任Glen Gejerman博士指出：“这些研究结果在临床上的潜在影响是重大的。在过去20多年里，局部、非转移性前列腺癌的标准治疗几乎没有出现新的治疗手段或显著改变。如果CAN-2409获批，它可能会彻底改变治疗范式，为这类患者提供一种有效的新选择，显著降低复发风险，并减少那些严重影响生活质量的挽救性治疗的需求。”CAN-2409还正在其他适应症中接受评估：在2期LuTK02研究（NCT04495153）中，联合伐昔洛韦或阿昔洛韦与免疫检查点抑制剂，用于III期或IV期非小细胞肺癌（NSCLC）。研究结果显示：在对免疫检查点抑制剂治疗反应不佳的晚期非小细胞肺癌（NSCLC）患者中，接受CAN-2409治疗的患者，平均总生存期（OS）为24.5个月。接受免疫检查点抑制剂治疗后出现疾病进展的患者，平均总生存期（OS）为21.5个月。在2期PaTK02研究（NCT02446093）中，联合伐昔洛韦或阿昔洛韦与标准放化疗，用于“边界可切除”型胰腺导管腺癌（PDAC）。研究结果显示：接受CAN-2409治疗的患者，平均总生存期（OS）为31.4个月，而仅接受标准治疗的患者，平均总生存期（OS）仅为12.5个月。两组24个月的总生存率分别为71.4%和16.7%。2023年4月，美国食品药品监督管理局（FDA）授予CAN-2409联合伐昔洛韦和帕博利珠单抗快速通道资格，适应症为：对一线PD-1/PD-L1抑制剂耐药，且不具有驱动基因突变或已对靶向治疗无效的III期或IV期非小细胞肺癌（NSCLC）患者。2023年12月，该组合治疗也被授予在胰腺导管腺癌（PDAC）中的快速通道资格。3.癌症疫苗mRNA-4157（V940）适应癌种：黑色素瘤、肺癌等实体瘤研发公司：美国默沙东（Merck）与Moderna公司联合来源：Moderna公司官网基于mRNA的癌症疫苗也在多种肿瘤类型中进行开发，其中包括mRNA-4157（V940）。mRNA是一种传递遗传信息的分子，用于指导细胞合成蛋白质。mRNA-4157（V940）是一种个体化癌症疫苗，也被称为“新抗原疫苗”。它的设计理念是：根据每位患者肿瘤的突变信息，专属定制一段mRNA，蕞多可覆盖34种癌细胞特有的“新抗原”序列。这些合成的mRNA进入体内后，将引导身体产生这些“标记”的仿真蛋白，从而训练免疫系统精准识别并攻击癌细胞。在2期KEYNOTE-942研究（NCT03897881）中，研究对象为完成手术切除的IIIB至IV期黑色素瘤患者。关键数据如下：接受mRNA-4157（V940）联合帕博利珠单抗治疗的患者，平均无复发生存期（RFS）尚未达到，意味着大部分人还没复发，治疗效果有希望更持久；而单独使用帕博利珠单抗的患者，平均无复发生存期（RFS）为42.51个月。两组比较的风险比为0.510，意味着联合治疗组相比对照组，复发或死亡风险降低了约49%。联合治疗组30个月的无复发生存率为74.8%，意味着接受治疗后到第30个月时，74.8%的患者病情没有复发，也没有死亡；对照组为55.6%。此外，联合治疗组在远处转移无进展生存期（DMFS）方面，也展现出明显优势，意味着联合治疗组在防止癌细胞向身体其他部位扩散方面效果更好。2024年10月，美国默沙东（Merck）与Moderna公司联合启动3期INTerpath-009试验（NCT06623422），进一步验证mRNA-4157（V940）联合帕博利珠单抗，在II至IIIB期非鳞状非小细胞肺癌（NSCLC）患者术后辅助治疗中的效果。试验人群为术前已接受帕博利珠单抗+化疗，但未达到病理完全缓解（pCR，指治疗后在手术切除的组织中未发现任何癌细胞残留）的患者。此外，还有两项3期研究正在同步进行：INTerpath-001（NCT05933577）研究：主要评估mRNA-4157（V940）在切除后高风险IIB至IV期黑色素瘤患者中的应用；INTerpath-002（NCT06077760）研究，主要评估mRNA-4157（V940）在非小细胞肺癌（NSCLC）患者中的辅助治疗价值。正如Glen Gejerman博士所总结的：“癌症疫苗的未来令人无比振奋。我们正在见证多种新平台的发展与融合。新抗原疫苗的出现，让我们能够针对每位患者的独特突变进行设计；病毒载体的突破，提升了免疫响应强度；更有创新的联合策略不断涌现，将癌症疫苗与免疫检查点抑制剂、细胞疗法等结合，可能为许多耐药性癌症带来新的转机。”来源：https://www.onclive.com/view/cancer-vaccines-begin-to-take-center-stage-with-investigators-anticipating-an-even-brighter-future识别微信二维码，可添加药时空小编请注明：姓名+研究方向！