ELI-002

BOSTON, April 25, 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 that it will be sharing new preliminary data from the ongoing AMPLIFY-7P Phase 1/2 study in a poster presentation at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, being held May 31-June 4, 2024 in Chicago, IL. The AMPLIFY-7P study is evaluating the 7-peptide formulation of Elicio’s off-the-shelf investigational therapeutic cancer vaccine candidate, ELI-002 7P, in patients with mKRAS-driven solid tumors that are positive for minimal residual disease. ELI-002 7P is designed to stimulate an immune response against the seven KRAS mutations that drive 25% of all solid tumors. Presentation Details ASCO 2024 Abstract Title: AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with minimal residual disease–positive pancreatic and colorectal cancerAbstract Number: 2636Session Type and Title: Poster Session – Developmental Therapeutics—ImmunotherapySession Date and Time: June 1, 2024, 9:00 AM-12:00 PM CDT (10:00 AM-1:00 PM ET)Presenter: Craig E. Devoe, M.D., MHCM., Chief, Division of Medical Oncology & Hematology, R.J Zuckerberg Cancer Center, and Scientific Investigator, Northwell Health About ELI-002 Our lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with our AMP platform consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing 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 and potentially reducing the chance of bypass resistance mechanisms. About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing a pipeline of novel lymph node-targeted immunotherapies for the treatment of some of the most aggressive cancers. By combining expertise in immunology and immunotherapy, Elicio is harnessing the natural power of the immune system with the Amphiphile (“AMP”) technology, which allows for therapeutic payloads to be delivered directly to the lymph nodes, with the goal of enhancing the immune system’s cancer-fighting capabilities. By targeting cancer immunotherapies to the core of the immune response, AMP aims to optimize the lymph nodes’ natural ability to educate, activate and amplify cancer-specific T cells, which are essential for recognizing and eliminating tumor cells. Engineered to synchronize immunity in these highly potent sites, AMP is built to enhance the magnitude, potency, quality and durability of the immune response to drive antitumor activity. The Company’s R&D pipeline includes off-the-shelf therapeutic cancer vaccines ELI-002, (targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008 (targeting BRAF-driven cancers and p53 hotspot mutations, respectively). For more information, please visit www.elicio.com. 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 (the “PSLRA”). These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, including the potential advantages of the ELI-002 7P formulation, the expected participation and presentation at upcoming conferences, 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, including the timing of the availability of new preliminary data from the ongoing AMPLIFY-7P Phase 1/2 study; Elicio’s plans to research, develop and commercialize its current and future product candidates; and Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements. New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on Elicio’s 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 that was filed with the SEC on March 29, 2024, 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. Media ContactKristin PolitiLifeSci Communicationskpoliti@lifescicomms.com646-876-4783 Investor Relations ContactHeather DiVecchiaElicio TherapeuticsIR@elicio.com857-209-0153

在今年的美国癌症研究协会（AACR）年会上，众多科学家都在问这个问题：癌症疫苗的复兴时代来临了吗？随着许多早期的积极临床结果公布，越来越多的证据显示，癌症疫苗正逐步、稳定地被开发为现有癌症治疗的一部分，尤其是在肿瘤复发预防的应用上。今日，药明康德内容团队将根据AACR大会报告内容并结合公开资料，带领读者一窥癌症疫苗开发的最新进展。 一款理想的癌症疫苗需要能够训练患者体内免疫系统识别癌细胞的专属蛋白，并刺激免疫系统对癌细胞进行有效的攻击。根据纪念斯隆-凯特琳癌症中心（Memorial Sloan Kettering Cancer Center）癌症研究员Vinod Balachandran博士，开发有效癌症疫苗的关键在于识别理想的抗原、使用正确的递送系统，并选择合适的患者以及治疗时期。 癌症疫苗所识别的理想抗原需要具备肿瘤专一性，避免攻击正常细胞，且能引发患者的免疫反应。近年来由于人工智能（AI）与相关科技的飞速进步，许多生物医药公司能够通过AI分析患者肿瘤的测序结果，并与其正常组织相较，识别出个体化、具肿瘤专一性的抗原，进而改善癌症疫苗的有效性。而在大流行期间安全性获验证的mRNA递送系统，以及近年产业界在DNA递送与改良后病毒载体上的进步，也加速推动癌症疫苗的开发。而过去相关临床试验的失败也成为科学家在癌症疫苗开发旅程中宝贵的经验。在过去，癌症疫苗多在带有体积较大的肿瘤患者身上进行测试，这类患者的肿瘤极具免疫抑制性，因此难以激发有效的免疫反应。现在，科学家转向那些接受手术、放化疗和靶向疗法患者，或是针对处于疾病早期阶段的癌症患者进行癌症疫苗的测试，这些患者的疾病负担与肿瘤免疫抑制性相对较小。这一系列科技进步与治疗策略的转变正是推动近期癌症疫苗复兴的驱动力。 Moderna与默沙东（MSD）在2023年12月公布其所共同开发的个体化新抗原疫苗mRNA-4157的3年随访结果。分析显示，与Keytruda单药治疗相比，mRNA-4157联合Keytruda治疗可显著改善经手术切除高风险黑色素瘤患者的无复发生存期（RFS），可使复发或死亡风险降低49%，并改善无远处转移生存期（DMFS），使患者的远处转移或死亡风险降低62%。目前该款疫苗有三项临床3期试验进行中，分别用以治疗经手术切除的黑色素瘤、非小细胞肺癌与皮肤鳞状细胞癌患者。在这次AACR大会上，两家公司也公布mRNA-4157用以治疗晚期头颈癌患者的1期试验结果。分析显示，22例患者中有6名对产生完全缓解（CR）或部分缓解（PR），14例患者在中位38周的随访期间中疾病得到控制。 新抗原癌症疫苗作为患者在手术切除后的辅助疗法，以消除癌细胞微转移并预防复发是这次AACR大会中多项临床试验采取的策略。BioNTech在日前公布其针对经手术治疗的胰腺导管腺癌（PDAC）患者的个体化癌症疫苗autogene cevumeran的随访结果。这款疫苗去年所公布的数据显示16位接受该疗法的患者中，8人（50%）产生了T细胞免疫反应。而这次所公布的数据显示，该疫苗在3年随访期间，体内的T细胞免疫应答持续激活，所产生CD8+ T细胞克隆的中位寿命为5.5年，并且患者的RFS得到了持续的延长，印证了该疫苗的免疫持久性。 同时，Transgene公司也公布了其针对头颈癌的个体化新抗原疫苗TG4050的早期试验结果，该疫苗使用改良后的痘病毒作为疫苗载体。在中位18.6个月的随访期间，16位在手术后立即接种疫苗的患者没有一人复发，而另16位未接受疫苗的对照组患者中，已有3位复发。Transgene宣布该试验的2期部分将会在未来几周进行患者招募。 Geneos公司也在AACR上公布其以DNA质粒为载体的个体化癌症疫苗GNOS-PV02的1/2期试验结果。该试验达主要与次要终点，36名晚期肝癌患者中，有11名对该疫苗与Keytruda联合疗法产生应答，这大约是过去对照药物治疗应答率的两倍。该试验详细结果同步刊登于《自然》子刊Nature Medicine当中。 Elicio Therapeutics靶向多种KRAS突变的合成长肽疫苗ELI-002的首次人体试验数据也公布于今年的AACR大会中。分析显示，有84%接受ELI-002与双重免疫检查点抑制疗法的胰腺癌和结直肠癌患者产生T细胞免疫反应。对照组患者的中位RFS为4.01个月，ELI-002联合疗法组的中位RFS则尚未达成（P=0.0167）。 此外，Syncromune所开发的个体化癌症疫苗SV-102也在治疗转移性去势抵抗性前列腺癌（mCRPC）的1期试验当中展现总缓解率（ORR）高达85%的积极结果。在接受足够轮次治疗的13例患者中，有5例患者达成CR，6例患者达PR，2例患者病情稳定。 这次AACR大会中所公布癌症疫苗相关的一系列进展令人鼓舞，然而距离癌症疫苗成为临床治疗中的一部分仍有许多问题有待回答。而其中最重要之一便是癌症疫苗所产生免疫反应的持久性。虽然BioNTech所公布的疫苗随访结果初步显示该疫苗的免疫持久性，但这样的免疫反应能够持续多久，以及是否能在大多数、不同癌症种类的患者中复制，皆有待在各类癌症患者当中进行更长期的随访、更大型的2、3期临床试验来验证。 另一个同样值得探讨的是一款有效的癌症疫苗需要包含多少种癌症新抗原才能在患者中产生有效应答。BioNTech的疫苗编码多达20种新抗原，Transgene的疫苗编码多达30种，Moderna的疫苗则编码多达34种。一些公司，如Elicio，则正在开发包含较少抗原种类的“现货型”癌症疫苗，到底哪种策略对病患总体治疗最为理想仍有待商榷。虽然理论上包含更多抗原种类疫苗的治疗效果应该更好，然而包含较少抗原种类的疫苗是否也能达到类似效果亦值得进一步检视。此外，随着近年来各类创新免疫疗法的获批，这类疗法与癌症疫苗的联用以加强患者的免疫反应也逐渐成为趋势。因此在不同癌症患者中识别理想的疗法组合与给药时间点也将会是研究人员在日后所需回答的问题。 虽然仍有许多挑战需要克服，但这次AACR大会所公布的一系列积极临床结果，无疑为癌症疫苗的开发注入一剂强心针，让我们期待研究人员能够早日取得突破性的研究成果，将这类疗法带进临床实践，造福广大癌症患者。 参考资料： [1] Cancer vaccines gain momentum, after years of disappointing results. 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Retrieved April 10, 2024 from https://www.geneostx.com/geneos-therapeutics-announces-positive-phase-1-2-data-for-gt-30-trial-of-personalized-therapeutic-cancer-vaccine/ [8] Yarchoan M, Gane EJ, Marron TU, Perales-Linares R, Yan J, Cooch N, Shu DH, Fertig EJ, Kagohara LT, Bartha G, Northcott J, Lyle J, Rochestie S, Peters J, Connor JT, Jaffee EM, Csiki I, Weiner DB, Perales-Puchalt A, Sardesai NY. Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial. Nat Med. 2024 Apr 7. doi: 10.1038/s41591-024-02894-y. Epub ahead of print. PMID: 38584166. [9] Durable immunogenicity of ELI-002 2P in AMPLIFY-201: Lymph node targeted mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer. Retrieved April 10, 2024 from https://elicio.com/wp-content/uploads/2024/04/AACR_2024-ELI-002_Translational_Medicine_Poster.pdf [10] Syncromune® Inc. Presents Positive Results from SYNC-T™ SV-102 Phase 1 Trial at AACR Annual Meeting 2024. Retrieved April 10, 2024 from https://syncromune.com/2024/04/08/syncromune-inc-presents-positive-results-from-sync-t-sv-102-phase-1-trial-at-aacr-annual-meeting-2024/ 内容来源于网络，如有侵权，请联系删除。