A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.

开始日期2022-12-16

申办/合作机构

Greenwich LifeSciences, Inc.

NCT03014076

/ Completed临床1期

Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:
* Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
* Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
* Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab

开始日期2008-01-01

申办/合作机构

LumaBridge LLC

NCT00524277

/ Completed临床2期IIT

Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.

开始日期2007-01-01

申办/合作机构

San Antonio Military Medical Center

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100 项与 GLSI-100 相关的临床结果

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100 项与 GLSI-100 相关的转化医学

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100 项与 GLSI-100 相关的专利（医药）

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项与 GLSI-100 相关的文献（医药）

2008-09-01·Human vaccines

Monitoring circulating tumor cells in cancer vaccine trials

Article

作者: Merill, G. A. ; Carmichael, M. G. ; Holmes, J. P. ; McCall, S. ; Stojadinovic, A. ; Peoples, G. E. ; Ponniah, S. ; Benavides, L. C. ; Milford, A. L. ; Mittendorf, E. A. ; Gates, J. D.

The presence of circulating tumor cells (CTC) from various cancers has provided a wealth of information and possibilities. As the role of CTC detection in the treatment assessment of metastatic breast cancer becomes standard, there is interest in applying this tool in cancer vaccine development and clinical trial monitoring. Since we lack a proven immunologic assay that correlates with clinical response, CTC detection, quantification and phenotypic characterization may be a useful surrogate for clinical outcome. The Cancer Vaccine Development Program is involved in the development of HER2/neu peptide based vaccine development for the prevention of recurrence in HER2/neu expressing cancers like breast cancer. The CellSearch System (Veridex, LLC Warren, NJ) has been used by our lab in conjunction with in vivo and/or in vitro immunologic measurements to define a monitoring tool that could predict clinical response. Once validated, this assay could significantly shorten clinical trials and lead to more efficient assessment of potentially promising cancer vaccines.

2007-03-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Tumor Antigen–Specific T-Cell Expansion Is Greatly Facilitated byIn vivoPriming

1区 · 医学

Article

作者: Salazar, Lupe G. ; Higgins, Doreen ; Disis, Mary L. ; Dang, Yushe ; Knutson, Keith L. ; Goodell, Vivian ; Childs, Jennifer ; dela Rosa, Corazon

Abstract:

Purpose: Adoptive T-cell therapy is a promising strategy for the treatment of patients with established tumors but is often limited to specific cancers where tumor-infiltrating lymphocytes, the source of T cells for ex vivo culture, can be obtained. In this study, we evaluated the feasibility of expanding HER-2/neu–specific T cells derived from peripheral blood ex vivo following in vivo priming with a HER-2/neu peptide vaccine.Experimental Design: Peripheral blood mononuclear cells from cytomegalovirus (CMV)–seronegative and CMV-seropositive donors as well as HER-2/neu–positive cancer patients who had or had not been vaccinated with a HER-2/neu peptide–based vaccine was used as a source of T lymphocytes. Antigen-specific T-cell lines were generated by in vitro stimulation with antigen followed by nonspecific expansion on CD3/CD28 beads. The ability to expand antigen-specific T cells was assessed using IFN-γ and granzyme B enzyme-linked immunosorbent spot. The phenotype of the resultant T-cell lines was evaluated by flow cytometry, including the presence of FOXP3-expressing CD4+ T cells.Results: The frequencies of CMV-specific T cells generated from CMV+ donors were >11-fold higher than the frequencies from CMV− donors (P = 0.001), with 22-fold increase of total number of CD3+ T cells. The frequencies of HER-2/neu–specific T cells generated from the primed patients were >25-fold higher than the frequencies from unvaccinated patients (P = 0.006), with an average of a 19-fold increase of total number of CD3+ T cells. Using peripheral blood as the source of T cells did not result in concurrent expansion of FOXP3+CD4+ regulatory T cells despite the use of interleukin-2 in in vitro culture. Both CD4+ and CD8+ HER-2/neu–specific T cells could be expanded. The extent of ex vivo expansion correlated with the magnitude of immunity achieved during immunization (P = 0.008).Conclusion: Tumor-specific T cells can be efficiently expanded from the peripheral blood ex vivo following in vivo priming with a vaccine. This approach provides an effective method to generate tumor-specific polyclonal T cells for therapeutic use that could be applied to cancer patients with any tumor type.

2006-08-01·Annals of surgical oncology2区 · 医学

Investigating the Combination of Trastuzumab and HER2/neu Peptide Vaccines for the Treatment of Breast Cancer

2区 · 医学

Article

作者: Craig D. Shriver ; Catherine E. Storrer ; Elizabeth A. Mittendorf ; Sathibalan Ponniah ; George E. Peoples

BACKGROUND:

Trastuzumab, an anti-HER2/neu monoclonal antibody, is thought to promote HER2/neu receptor internalization and/or turnover. This study was designed to investigate the kinetics of trastuzumab treatment on tumor cells with varying levels of HER2/neu expression and to determine the effect of trastuzumab on HER2/neu-specific cytotoxic T lymphocyte-mediated lysis.

METHODS:

Three cell lines with varying levels of HER2/neu expression were incubated with varying doses of trastuzumab at multiple time points. Trastuzumab binding and HER2/neu expression were determined. Peripheral blood mononuclear cells from three HLA-A2(+) healthy donors and four E75 peptide-vaccinated patients were stimulated with HER2/neu-derived peptides and tested in standard chromium release cytotoxicity assays with HER2/neu(+) tumor cells pretreated with trastuzumab.

RESULTS:

Treatment of tumor cells with 10 microg/mL of trastuzumab in an overnight incubation resulted in saturation of cell-surface HER2/neu receptors. At higher doses, trastuzumab staining and HER2/neu expression decreased in a time-dependent manner. Pretreatment of tumor cells with trastuzumab resulted in increases in specific cytotoxicity by peptide-stimulated cytotoxic T lymphocytes from HLA-A2(+) donors over untreated cells by an average of 5.6% and 15.3% (P = .0002) for doses of 10 and 50 microg/mL, respectively. In similar experiments involving peripheral blood mononuclear cells obtained from immunized patients, the average specific cytotoxicity for untreated cells was 34.2% +/- 1.3% vs. 40.6% +/- 2.5% (P = .035) and 40.7% +/- 1.6% (P = .0005) for those treated with 10 and 50 microg/mL, respectively.

CONCLUSIONS:

Our data suggest that pretreatment of breast cancer cells with trastuzumab induces turnover of the HER2/neu protein and enhanced killing by HER2/neu peptide-stimulated CTLs. This increased lysis occurs regardless of the degree of HER2/neu expression and seems more pronounced in vaccinated patients. These findings support further investigation into the use of combination immunotherapy with trastuzumab and HER2/neu peptide-based vaccines.

项与 GLSI-100 相关的新闻（医药）

2026-07-30

·南京肽业

YM说多肽|2026年7月多肽最新技术进展

2026年7月多肽最新技术进展一、引言 2026年7月，全球多肽技术领域呈现出一幅多点突破、加速发展的繁荣图景。从单分子测序的基础工具创新，到人工智能驱动的药物设计范式变革；从代谢疾病三靶点激动剂的临床前验证，到抗菌肽的智能化挖掘；从合成方法学的革命性进步，到监管政策的历史性转向——多肽技术正在从"药物分子的补充者"向"治疗范式的引领者"加速蜕变。多肽药物之所以受到越来越多的关注，源于其独特的分子特性。通过10至50个氨基酸的序列排布，多肽将分子量锁定在1至5千道尔顿区间，精准填补了小分子化药（小于500道尔顿）与大分子蛋白（大于5000道尔顿）之间的治疗空白。这种中等规模的分子量不仅保留了小分子药物较强的组织渗透力，能够深入细胞内部，又兼具了大分子生物药的高特异性与低毒副作用。对于研发端而言，多肽的价值核心在于其能有效打击"不可成药"靶点（如蛋白-蛋白相互作用），同时显著降低了免疫原性风险。从市场规模来看，全球肽类疗法市场规模在2024至2025年间已突破1300亿美元，并正以约10%的年复合增长率向数千亿美元迈进。预计2024至2030年，多肽药物市场将以显著高于全球药品市场整体5%至8%的增速增长。产能端测算显示，2026年全球多肽原料药可用产能合计约340吨/年，而同期需求已达350吨/年，供需缺口预计将持续至2028年。在这样的大背景下，2026年7月涌现的一系列突破性进展尤为值得关注。二、基础研究突破2.1 南京大学黄硕团队开发纳米孔"逐字读取"技术，实现单分子肽序列精准解析蛋白质是生命活动的核心执行者，其序列信息是解码生物过程与疾病机制的关键钥匙。传统的Edman降解测序和质谱技术在检测灵敏度与动态范围上存在明显局限，难以对低丰度蛋白以及翻译后修饰进行全面、精准的分析。纳米孔是一种新兴的单分子测序技术，已经在核酸测序领域取得突破性进展，然而，纳米孔肽测序技术的开发面临着远超核酸测序的多重挑战，不仅需要精准区分构成肽链的20种天然氨基酸与种类繁多的翻译后修饰，还需要克服肽链折叠结构与非均匀电荷分布所带来的检测困难。 2026年7月，南京大学黄硕团队在这一领域取得了里程碑式的进展。该研究提出了一种全新的纳米孔多肽测序策略——瞬态孔-分析物环化（transient Pore Analyte Looping，tPAL）。该策略通过工程化改造纳米孔、固定单个肽分子，并结合酶促逐步切割，实现了对肽链氨基酸序列的连续读取，为单分子蛋白质测序领域带来了新的技术路线。研究团队开发了一种经工程改造的耻垢分枝杆菌porin A蛋白纳米孔，该孔道经镍离子结合的次氮基三乙酸适配体与目标肽段双重修饰。这种独特的传感构型通过多次重读实现了对固定化肽段氨基端的精准识别。借助胆固醇化氨肽酶，固定化肽段能以单氨基酸为增量逐步缩短，产生序列依赖、阶跃式且分布窄的信号变化，为肽段序列解码提供线索。该研究利用纳米孔技术提出了tPAL策略，通过"固定肽分子-重复读取-逐步切割-信号解析"的创新模式，实现了单分子肽序列的单氨基酸分辨率的解析，可有效识别单氨基酸突变、翻译后修饰及非天然氨基酸插入——表明其在纳米孔蛋白质组学与手性肽分析中具有广泛适用性。同期，该团队还报道了基于肽段拼接的纳米孔肽测序新方法。研究进一步搭建了纳米孔肽事件数据库，通过比对多酶酶切产生的重叠片段的特征事件，成功组装出肽的原始序列，同时可精准定位单氨基酸突变、缺失与翻译后修饰位点等。这些进展共同标志着纳米孔肽测序正从概念验证走向实际应用的新阶段。2.2 短肽相变的手性调控研究取得突破手性是生物分子的重要化学参数之一，在生命活动中扮演着关键角色。2026年7月，关于手性对短肽相变行为调控的研究揭示了其深刻的生物学意义。研究者对前期开发的三肽-药物偶联物进行手性工程改造，构建了多对手性对映体。他们发现，具有交替D/L构型的杂手性肽在生理条件下可通过立体化学-离子协同作用发生液-液相分离，形成液态凝聚体。而其他手性异构体则倾向于形成富含β-折叠的水凝胶。计算模拟进一步表明，钠离子或钾离子可通过阳离子-三肽相互作用稳定亚稳态凝聚体，从而抑制纤维化进程，揭示了一种阳离子可调的液-液相分离机制。在此基础上，研究者深入探索了不同相变性质短肽的生物学效应。研究发现，在高表达碳酸酐酶IX的肿瘤细胞中，同手性短肽更易在细胞表面富集并形成自组装纤维结构；而D/L构型交替的杂手性肽则需在溶酶体酸性条件下，通过质子化作用破坏亚稳态阳离子-三肽凝聚体结构，导致纳米纤维的形成。这一过程显著提升了药物对肿瘤细胞溶酶体的靶向性，增强了对碳酸酐酶IX蛋白的抑制作用，同时提升溶酶体膜通透性，有效促进肿瘤细胞内芬顿反应并诱导铁死亡，最终提高了乳腺肿瘤的抗肿瘤疗效。这两项研究不仅深化了对生物分子相变物理化学基础的理解，更为肽类药物递送系统的理性设计提供了全新的手性工程策略。2.3 中国科学院昆明植物所利用AI从天麻基因组挖掘广谱抗菌候选肽抗菌肽是生物体先天免疫系统经诱导产生的一种具有广谱抗菌活性的小分子多肽，也是天然免疫系统的重要组成部分。随着抗生素等抗菌药物的滥用，细菌耐药性问题日益严峻。2026年7月，中国科学院昆明植物研究所胡江苗研究团队联合云南大学，以天麻全基因组数据为资源起点，结合蛋白资源挖掘、生成式人工智能设计、生物物理实验和分子动力学模拟，获得了广谱抗菌候选肽GT-2。天麻是一种完全菌异养型药用兰科植物，终其一生绝大部分时间生活于地下。在种子萌发阶段，它严格依赖小菇属真菌提供营养，后续营养生长阶段则转而依赖蜜环菌。这种独特的双重真菌依赖型生活史，使天麻始终处于植物与微生物互作的环境，也暗示其基因组和防御相关蛋白中可能蕴藏着尚未被充分发掘的功能肽资源。研究团队从天麻防御相关编码蛋白中计算获得2924条肽片段，经过生物活性、长度、抗菌潜力和安全性等多轮筛选，得到10条候选肽。由于这些天然蛋白片段的直接抗菌活性较弱，团队进一步选择GP-1作为起始骨架，利用DeepAMP生成模型和D-POS优化流程探索序列空间，最终获得GT-2。GT-2并非从天麻组织中直接分离的天然肽，而是由天麻蛋白资源提供分子起点、再经生成式设计和优化获得的先导候选肽。体外实验表明，GT-2对白色念珠菌、铜绿假单胞菌、金黄色葡萄球菌、大肠杆菌和耐甲氧西林金黄色葡萄球菌均具有抑制活性，最低抑菌浓度为4至32微克/毫升，并可破坏微生物膜和抑制生物膜形成。在500微克/毫升时，GT-2的兔红细胞溶血率低于5%，显示出良好的选择性。在铜绿假单胞菌感染的小鼠皮肤创伤模型中，局部给药后创面可培养菌量降至检测限以下。进一步研究发现，GT-2在水相中主要保持柔性、无序状态；进入含磷脂酰乙醇胺或磷脂酰肌醇的细菌样和真菌样膜环境后，则更容易形成螺旋结构并与膜深入结合。相比之下，纯磷脂酰胆碱和胆固醇相关的哺乳动物样细胞膜环境较不利于其有效插入。脂质拮抗实验、光谱分析和全原子分子动力学模拟共同支持"脂质依赖的膜结合"工作模型。这一工作推动了天麻活性成分研究从传统小分子发现延伸至人工智能驱动的新型抗菌肽挖掘，展现了基因组挖掘与生成式人工智能相结合在天然产物药物发现中的巨大潜力。2.4 其他AI抗菌肽设计研究进展 2026年7月，还有多项人工智能驱动的抗菌肽研究取得进展。有研究系统梳理了基于人工智能挖掘微生物组抗菌肽的方法学体系。有研究者提出了基于可解释人工智能框架的计算流程，用于理性从头设计高活性抗菌和抗生物膜肽。另有研究建立了基于人工智能的D-氨基酸取代优化框架，通过D-氨基酸取代增强抗菌肽的稳定性，实现高效发现具有增强临床转化潜力的有效且稳定的候选物。韩国研究者开发了一个基于Transformer的框架，用于设计具有特性感知和部分长度可控的新型抗菌肽，推动人工智能驱动策略探索肽空间并应对抗菌药物耐药性。此外，有课题组聚焦多肽、抗体和适配体三类重要生物分子，全面总结了机器学习、蛋白质语言模型、图神经网络、Transformer及扩散模型等前沿AI技术在分子设计中的应用。三、多肽药物研发进展3.1 翰宇药业HY3003：三靶点激动剂临床前减重优于替尔泊肽与瑞他曲肽 2026年7月，翰宇药业披露了其新一代GLP-1/GIP/GCGR三重受体激动剂HY3003注射液的临床前药效学研究结果。HY3003是翰宇药业与深圳碳云智肽药物科技有限公司合作开发的一款新型GLP-1R/GIPR/GCGR三重受体激动剂。该项目通过人工智能结合多肽芯片技术筛选得到新型多肽分子，由翰宇药业负责临床前研究、IND申报及后续临床试验开发。目前，项目已完成临床前候选化合物筛选和原料药及制剂开发，同步推进周制剂、月制剂及口服制剂的临床前试验。在高脂饮食诱导的DIO小鼠模型中，HY3003展现出了令人瞩目的减重效果。预实验中，研究人员每三日一次皮下注射HY3003或替尔泊肽、瑞他曲肽进行给药。四周后结果显示，同摩尔剂量下，HY3003对DIO小鼠的减重效果约为-57.2%，优于瑞他曲肽的-43.8%；同等剂量下，HY3003减重效果约为-66.2%，优于替尔泊肽的-45.6%。另一项实验中，每三日一次皮下注射HY3003或替尔泊肽，四周后同摩尔剂量下HY3003减重效果约为-56%，优于替尔泊肽的-42%。结果显示，HY3003在饮食诱导的肥胖动物模型中具有良好的减重、减脂甚至降糖效果；对比替尔泊肽及处于临床III期的瑞他曲肽，同等摩尔剂量下减重、降糖和减脂效果显著。围绕GLP-1药物领域，翰宇药业已形成从原料药到制剂、从仿制药到创新药的梯度矩阵：利拉鲁肽注射液获美国FDA首仿批准并商业化，司美格鲁肽注射液降糖、减重两项III期临床达到等效标准并推进上市申请，替尔泊肽注射液降糖及减重两个ANDA亦获FDA首仿受理。HY3003正是公司在这一基础上向更前沿三靶点创新药迈出的关键一步。双方于2024年10月达成战略合作，2025年5月签署联合开发协议，碳云智肽负责分子筛选，翰宇药业负责临床前研究、IND申报、临床试验及产品注册申报，形成"AI+多肽芯片筛选"与产业化开发相结合的协同路径。HY3003长效缓释制剂通过储库缓释机制，旨在维持体内药物浓度平稳，减少血药浓度高峰带来的胃肠道不良反应。3.2 众生药业RAY1225注射液获日本核心专利 2026年7月，广东众生药业股份有限公司发布公告称，公司控股子公司广东众生睿创生物科技有限公司收到日本特许厅颁发的专利证书。专利名称为"多肽在制备治疗和/或预防糖尿病及肥胖症及其相关疾病药物中的制药用途"。该专利是公司在研创新结构多肽药物RAY1225注射液的核心专利。RAY1225注射液具有GLP-1受体和GIP受体双重激动活性，具备每两周注射一次的超长效药物潜力。目前公司正在推进其用于肥胖/超重的III期临床试验（REBUILDING-2），以及单药和联合用药治疗2型糖尿病的III期临床试验（SHINING-2、SHINING-3）。3.3 Rhythm Pharmaceuticals setmelanotide III期结果公布 2026年7月，Rhythm Pharmaceuticals宣布，评估黑皮质素4受体激动剂setmelanotide治疗获得性下丘脑性肥胖患者的关键性3期TRANSCEND试验结果公布。研究数据显示，setmelanotide治疗使成人和4岁及以上儿童患者的体重和饥饿感显著改善。在这项为期52周、随机、双盲、安慰剂对照的3期研究中，接受setmelanotide治疗的患者实现了与安慰剂相比身体质量指数经安慰剂校正后的降幅差异为19.8%；在52周时，所有接受setmelanotide治疗患者的BMI较基线平均下降16.5%，达到主要终点；相比之下，安慰剂组患者的BMI变化为提高3.3%。3.4 ITM-11放射性多肽疗法III期结果公布 2026年7月，ITM Isotope Technologies宣布，其在研放射性治疗药物¹⁷⁷Lu-edotreotide（ITM-11）对比依维莫司治疗晚期胃肠胰神经内分泌肿瘤患者的3期COMPETE研究主要结果公布。3.5 国家药监局集中批准多款创新药 2026年7月，国家药监局集中批准四款自主研发1类创新药，涵盖中药外用、口服小分子、长效多肽、全人源单抗四大药物类型，多款产品斩获国内首款里程碑突破。其中长效多肽类药物的获批进一步丰富了国内多肽药物市场。3.6 石药集团收到阿斯利康研发里程碑付款 2026年7月10日，石药集团公告，集团此前与阿斯利康签订战略合作与授权协议，收到阿斯利康就战略合作与授权协议项下的2500万美元研发里程碑付款。3.7 诺和诺德Amycretin 3期临床完成首例患者给药诺和诺德宣布，其口服GLP-1/胰淀素双受体激动剂amycretin在肥胖症或超重成人中开展的3期临床已完成了首例患者给药。此次进展是基于之前的数据：在伴有或不伴有2型糖尿病的肥胖或超重成人中，amycretin治疗在第20周时体重降幅达13.1%，且在12周后继续呈下降趋势。此前的2期数据显示，接受最大剂量amycretin治疗的患者在20周后体重下降13.1%，而安慰剂组患者的体重下降了1.1%。同时，amycretin具有良好的安全性和耐受性，最常见的不良事件为胃肠道反应，且大多为轻中度。3.8 歌礼制药ASC35获FDA批准开展I期研究歌礼制药的每月一次皮下注射GLP-1R/GIPR双靶点多肽ASC35于2026年6月获美国FDA批准开展I期研究，试验计划入组84名肥胖或超重受试者，并在多次给药阶段与每周一次替尔泊肽进行头对头比较。歌礼制药的三靶点激动剂ASC37每月一次皮下制剂和口服制剂的新药临床试验申请将于2026年第三季度递交，生物制品许可申请将在III期临床完成后向FDA递交。3.9 德源药业DYX116进入临床II期德源药业的GIPR/GLP-1R/GCGR三重激动剂多肽DYX116已经进入临床II期研究，适应症为2型糖尿病和减重。3.10 吉利德Hepcludex获FDA加速批准用于慢性丁型肝炎 2026年7月，吉利德科学旗下Hepcludex（bulevirtide）注射液获得美国FDA加速批准，用于治疗无肝硬化或代偿性肝硬化成人患者的慢性丁型肝炎病毒感染。这是首款获FDA批准用于该疾病的疗法。bulevirtide是一种合成的N-乙酰化肽，由47个氨基酸组成，源自于乙型肝炎病毒大包膜蛋白的N端前结构域，通过结合并阻断肝脏细胞上的钠离子-牛磺胆酸共转运多肽受体，阻止HDV和HBV进入肝细胞。这一批准标志着多肽药物在抗病毒领域的重要突破。3.11 肿瘤免疫领域多肽疫苗与纳米药物进展在肿瘤免疫治疗领域，多肽技术同样展现出强劲的创新活力。 2026年7月，一项关于实验性KRAS疫苗的研究成果对外公布。该研究评估了一种靶向胰腺癌中六种最常见KRAS突变的多肽疫苗。数十名具有胰腺癌遗传易感性且通过影像学检查发现胰腺异常的参与者于2022年至2026年期间接受了该疫苗。研究结果表明，该疫苗能够在具有遗传性胰腺导管腺癌易感性的个体中产生持久的T细胞应答。在纳米疫苗方面，同期的一项研究创建了一种技术先进的聚合物基多价肽疫苗，通过共递送脂质偶联的肿瘤特异性肽与Toll样受体7/8激动剂和STING激动剂，增强了癌症免疫治疗效果。虽然有多项使用新抗原肽基癌症疫苗的临床试验正在进行，但仍然存在抗原稳定性差、递送效率不足和免疫激活不充分等挑战。该研究通过多功能纳米疫苗设计，有望克服上述局限性。此外，还有研究报道了基于GPC3抗原肽的纳米疫苗，用于增强肝细胞癌的免疫治疗效果。在D-肽纳米药物方面，研究者开发了一种具有蛋白酶稳定性的D-肽VISTA抑制剂，具有高结合亲和力和优异的体外血清稳定性。该抑制剂与Toll样受体7/8激动剂共同装载到基质金属蛋白酶-2响应的纳米平台中，在结直肠癌肿瘤模型中显著增加了瘤内CD8阳性T细胞浸润，实现了强效的抗肿瘤效果且无明显的全身毒性。 Greenwich LifeSciences的GLSI-100（GP2+GM-CSF）多肽肿瘤疫苗正在III期临床（FLAMINGO-01）中评估其在HER2/Neu阳性乳腺癌高复发风险人群中的疗效与安全性，预计2026年12月完成主要终点。3.12 其他适应症领域进展 BioMarin的Vosoritide（一种C型利钠肽类似物）正在开展针对轻型软骨发育不全的III期临床研究（CANOPY-HCH-3），预计2026年8月完成主要终点。阳光诺和全资子公司诺和晟泰的STC009注射液获得临床试验批准，拟用于继发性甲状旁腺功能亢进症。STC009是依托iCVETide多肽新药发现平台开发的钙离子敏感受体多肽激动剂。非临床研究显示，STC009在具有良好血清PTH降低效果的同时，血钙及血磷水平能够快速回升，低钙血症风险大幅降低。四、合成技术创新4.1 合肥工业大学与清华大学合作开发中性水相多肽酰肼连接新方法多肽酰肼的自然化学连接作为蛋白质化学合成领域的主流技术，已被广泛用于数百种功能多肽及蛋白分子的获取。然而传统的多肽酰肼连接反应需要在强酸性条件下活化酰肼，随后在中性条件下进行肽片段连接，这一反应模式依赖对反应溶液pH值的严格精细调控，影响了整体合成效率，且难以适配微量样品合成、高通量自动化多肽合成等反应场景。 2026年7月，合肥工业大学食品与生物工程学院李宜明教授课题组储国超副教授与清华大学刘磊教授课题组合作开发了一种铁氰化物介导的多肽酰肼氧化-偶联新体系，在单一中性水相中实现多肽酰肼的高效活化与肽片段拼接。新反应操作便捷，可适配2.5至200微升微量反应体系，大幅降低高价肽原料损耗，且反应条件温和、底物兼容性广，成功实现了抗菌肽、环肽、反手性蛋白、翻译后修饰蛋白等系列功能分子的高效合成。新方法大幅简化了多肽及蛋白的合成流程，提升了反应稳定性与合成效率，为多肽药物、功能蛋白创制提供了关键技术。同期，李宜明教授课题组联合清华大学刘磊教授建立基于临时结构支撑的胰岛素单次固相合成策略。借助临时支架介导A链和B链在固相上的有序组装，实现了胰岛素及A/B链异二聚体活性多肽药物的一次性快速固相合成。这一突破有望满足人工智能驱动下海量新型多肽分子的快速合成与高通量筛选需求。4.2 清华大学刘磊团队将可合成氨基酸规模从100个提升至900个 2026年7月，清华大学化学系主任刘磊教授介绍，团队发现了肽酰肼连接反应，构建了以多肽酰肼为核心的完整蛋白质化学合成体系，将可合成氨基酸规模从100个提升至900个，这套方法可用来构建突破天然限制的功能蛋白。北京大学陈鹏教授介绍，团队聚焦活细胞化学，针对传统反应难以脱离生理环境的难题，搭建活细胞化学反应体系，实现蛋白原位调控、体内精准合成，拓展了肿瘤免疫治疗路径。北京大学焦宁教授介绍，团队发现改性产物和1,3-丁二烯共聚可大幅提升橡胶韧性。南方科技大学化学系主任刘心元教授指出，团队研发了从烷烃一步合成手性药物中间体的体系，打通了石油原料到抗肿瘤、降糖药物的制备通道。4.3 国立阳明交通大学与高雄医学大学合作突破困难肽制造瓶颈近年来，GLP-1减重药物迅速发展和精准医疗的快速推进，带动全球肽药物市场蓬勃成长。然而，许多具潜力的新药开发计划却面临共同挑战：药物设计完成后，往往卡在制造阶段，特别是长链肽、环状肽及特殊修饰肽，由于合成困难、产率偏低、纯化复杂及成本高昂，使研发进程受到限制。由国立阳明交通大学药学系副教授陈惠亭与高雄医学大学特聘教授高佳麟共同领导的研发团队，长期投入特殊肽与困难肽合成技术开发，并以自主研发的"固相链结肽合成平台"荣获第22届国家新创奖肯定。现有肽制造技术在面对超过30个氨基酸以上的长链肽时，容易出现产率下降与副产物增加等问题，后续纯化成本也大幅提高。尤其近年热门的减重药物与长效型肽药物，多数同时具有长链结构、脂肪酸修饰及非天然氨基酸等特性，更增加制程开发难度。为突破产业限制，团队开发固相链结肽合成平台，将片段合成与链结反应整合于固相系统中完成，减少传统合成的制程所需的大量分离与纯化步骤。相较于既有方法，新平台可提升合成效率与产品纯度，同时降低副产物生成风险，并适用于长链、环状、两亲性及特殊修饰等高难度肽结构。团队建立的模组化片段设计与固相链结技术，可大幅缩短开发时程，让研究团队与新药研发公司更有效率地验证药物候选分子，加速推进后续临床研究。4.4 中国医学科学院药物所在O-糖基化氨基酸高效化学合成领域获进展中国医学科学院药物研究所开发了一条简洁、高效的O-糖基化氨基酸化学合成新路线，实现天然糖基化生长激素释放激素的精准制备与生物学评价，并证实O-糖基化修饰可大幅提升GHRH抵抗蛋白酶降解的能力。研究围绕O-糖基化氨基酸的高效制备开展系统攻关，创新性地构建了兼具区域选择性糖基化和高立体选择性α-唾液酸化的合成策略。该策略从通用共同中间体出发，通过发散式合成设计，仅需最多三步即可制备包括双唾液酸四糖在内的14种O-糖基化氨基酸。与传统工艺相比，新路线缩短合成步骤，大幅提升制备效率，为糖蛋白分子的精准化学构建提供了一种简便、低成本、普适性更强的技术平台。基于这一高效合成体系，研究结合固相多肽合成技术，成功制备天然糖基化修饰的GHRH分子，并开展酶稳定性测试。结果表明，O-糖基化修饰可增强GHRH抵抗DPP-IV酶降解的能力，为GHRH类多肽药物的结构优化和临床开发提供全新思路。4.5 润辉生物多肽固相合成智能化生产润辉生物是国内少数同时掌握生物多肽固相合成与多糖类生物合成两大核心技术的企业。从氨基酸投料到肽链延长，从裂解纯化到冻干包装，数百个工艺参数被传感器转化为数字语言，在中央控制系统里有序运行。在多肽固相合成工艺中，固相载体树脂是肽链生长的物理支撑，更是决定多肽羧基端化学形式（游离酸或酰胺）与合成效率的关键因素。五、人工智能赋能多肽药物设计5.1 分子之心MMDesign平台环肽从头设计获得湿实验验证在2026世界人工智能大会期间，国内AI生物科技企业"分子之心"宣布，其自主研发的AI生物药设计平台MMDesign在环肽从头设计领域取得关键突破，并在多个长期被视为"难成药"的蛋白-蛋白相互作用靶点上获得湿实验验证。一直以来，靶向蛋白-蛋白相互作用是全球创新药研发的"圣杯"之一，这类靶点与肿瘤、免疫、自身免疫性疾病等密切相关。但由于其结合界面广且平坦，传统小分子药物难以有效作用，长期受困于"难成药"的尴尬境地。环肽药物被业界公认为攻克这一难题的"杀手锏"。它介于小分子与大分子之间，既具备小分子较好的组织渗透性，又拥有抗体药物对复杂靶点的强识别能力。然而，环肽极具商业前景的背后是极高的设计门槛：其序列、环化方式与三维结构高度耦合，可探索的分子空间犹如宇宙繁星。实验数据显示，在p53-MDM2靶点上，MMDesign首轮设计并进入测试的21条候选环肽中，有16条获得实验命中，命中率超过70%；其中，最优候选分子的结合亲和力达到13.7微摩尔，优于同期实验阳性对照。在PD-L1靶点上，AI首轮设计的19条候选环肽中，有6条经表面等离子体共振实验确认可与靶点结合，最佳结合亲和力接近40微摩尔。参照全球公开报道的AI多肽从头设计结果，这组在两个经典PPI靶点上取得的首轮命中率与结合活性数据，处于全球同类工作的领先水平。分子之心创始人、国际计算生物学会会士许锦波认为，真正具有产业壁垒的AI平台，需要系统建模蛋白质结构、局部构象、化学相互作用与生物功能之间的关系，并经受住真实湿实验数据的反复校准。目前分子之心的MMDesign及各项跨模态设计能力，正陆续集成至其自主研发的AI大分子设计操作系统MoleculeOS（简称MOS），这是一个集成了蛋白质结构预测、分子生成、物理验证、实验数据管理于一体的统一大平台。5.2 晶泰科技与甘李药业"AI智肽递送实验室"正式揭牌 2026年7月10日，AI制药企业晶泰控股与代谢疾病领域企业甘李药业联合共建的"AI智肽递送实验室"，获得"北京市重点实验室"认定并正式揭牌。这是继2025年11月双方建立战略伙伴关系以来的又一重要合作进展，标志着双方在AI赋能多肽药物研发领域的合作步入全面深化阶段。该联合实验室主要围绕三大方向开展技术攻关：一是打造AI驱动的"虚拟筛选+湿实验验证"一体化平台，推进代谢性慢病治疗多肽分子的设计与成药性优化；二是开发新型口服递送系统，提升多肽药物的胃肠道稳定性、跨膜转运效率及生物利用度；三是探索超长效递送与缓释制剂技术，推动给药向更长周期延展。目前，晶泰控股PepiX平台已实现多赛道技术落地，正在重点布局多款脑部递送、眼部递送及口服肽等高潜力多肽药物的开发并取得多项标杆性成果。其中，PepiX研发的食品级口服功能肽Tensotide已正式获得美国Self-affirmed GRAS认证，可合法用于美国食品及膳食补充剂市场。5.3 英灵殿科技累计融资近5000万美元，自研全模态分子世界模型 2026年7月，AI4S赛道企业英灵殿科技宣布，三个月内连续完成多轮融资，累计近5000万美元。其创始人张昊天提出"全模态分子设计"理念。公司迭代研发AlloDesign系统，已在环肽设计领域取得进展，短期以药物发现为落地场景，中长期打造Scientific AGI底层平台。5.4 PeptiVerse平台多肽治疗特性预测 2026年7月，一项关于PeptiVerse平台的研究被报道。治疗性多肽结合了小分子和抗体的优点，提供了靶点灵活性和低免疫原性，但其成功转化需要仔细评估结合之外的多项可开发性特性。随着化学修饰多肽在药物设计中日益普遍，PeptiVerse作为一个统一的多肽治疗特性预测平台应运而生。六、监管与市场动态6.1 全球多肽CDMO进入产能扩张周期全球多肽CDMO进入产能扩张周期，以承接多肽药物市场需求。国内外的多肽CDMO公司均加大对于产能的投资建设，尤其注重从临床前到商业化生产的一站式服务能力建设。海外CDMO方面：2024年7月，CodernaPharma宣布对美国及欧洲的产能投入9亿欧元的投资，到2025年追加至10亿欧元；Bachem在瑞士和美国均进行扩建，核心扩建项目Building K在2025年顺利通过cGMP审计并产出首批GMP批次，2026年进入第一部分产能放量爬坡期；PolyPeptide在欧洲、美国、印度产能同步扩张，2026年资本支出预计达到收入的15%至20%。国内CDMO方面：药明康德共有三座TIDES工厂处于建设中，均计划于2027年投入使用，泰兴的两座工厂用于寡核苷酸、多肽及PMO生产；新加坡工厂将加强公司小分子及TIDES的全球API生产能力。2026年4月，凯莱英医药与天津经开区管委会签署合作备忘录，在天津经开区持续扩建化学大分子创新药CDMO研发生产基地，预计投资规模达20亿元人民币。药明康德旗下专注于寡核苷酸、多肽及相关化学偶联药物的CRDMO平台WuXi TIDES为全球合作伙伴开发TIDES药物提供高效、灵活和高质量解决方案。6.2 四川双马多肽原料药产能将扩至10吨/年四川双马湖北原料药生产基地现有多肽原料药年产能已突破4吨，其中GLP-1类原料药年产能达2吨。目前重点推进的A16车间已完成土建工程，净化装修及设备安装正按计划进行，近期将进入设备调试阶段，预计于2026年下半年正式投产。投产后公司多肽原料药总产能将提升至10吨/年，同时，公司依据市场需求已启动新的产能建设规划，进一步强化规模化供应能力。公司重点锚定GLP-1多肽及偶联药物等高景气赛道。七、展望与总结回顾2026年7月多肽技术的进展，可以清晰地看到几条贯穿性的趋势。第一，基础工具的革命正在加速。南京大学黄硕团队开发的纳米孔"逐字读取"技术，通过瞬态孔-分析物环化策略实现了单氨基酸分辨率的肽序列测定，解决了长期以来纳米孔肽测序分辨率不足、信号均一性差的关键瓶颈。该方法能够直接识别肽链中的单个氨基酸突变、翻译后修饰及非天然氨基酸插入。同期报道的基于肽段拼接的纳米孔肽测序方法，进一步拓展了检测能力。这些进展有望像DNA测序一样重塑生命科学的研究范式。第二，人工智能正在重塑多肽药物的发现范式。分子之心MMDesign平台在环肽从头设计上获得湿实验验证，针对p53-MDM2靶点命中率超过70%；晶泰控股与甘李药业联合共建的"AI智肽递送实验室"获得北京市重点实验室认定；英灵殿科技累计融资近5000万美元，自研AlloDesign系统。人工智能已深入渗透到多肽药物研发的各个环节——从分子发现、性质预测到递送系统设计。第三，多肽药物的治疗版图持续拓展。代谢疾病领域，翰宇药业HY3003三靶点激动剂临床前减重效果优于替尔泊肽与瑞他曲肽；众生药业RAY1225注射液获日本核心专利，具备每两周注射一次的潜力；Rhythm Pharmaceuticals setmelanotide III期结果显示BMI经安慰剂校正后降幅达19.8%；诺和诺德amycretin 3期临床完成首例患者给药；歌礼制药ASC35获FDA批准开展I期研究。放射性多肽疗法ITM-11的III期COMPETE研究结果公布。国家药监局集中批准多款创新药，覆盖长效多肽等多个药物类型。吉利德Hepcludex获FDA加速批准，成为首款用于慢性丁型肝炎的疗法。第四，产业化能力快速提升。合肥工业大学与清华大学合作开发了中性水相多肽酰肼连接新方法，大幅简化了多肽及蛋白的合成流程。清华大学刘磊团队将可合成氨基酸规模从100个提升至900个。国立阳明交通大学与高雄医学大学团队开发的固相链结肽合成平台荣获国家新创奖肯定。全球多肽CDMO进入产能扩张周期，药明康德、凯莱英等国内企业加速扩产。第五，监管与市场的双向互动正在形成新格局。全球多肽原料药供需缺口预计将持续至2028年。多款多肽新药的获批上市和产业化能力的快速提升，共同勾勒出一个从实验室到市场的多层次产业发展图景。多肽药物正处于小分子与生物大分子之间的"黄金分割点"——既保留了小分子的组织渗透力，又兼具大分子的高特异性与低毒副作用。2026年7月的一系列进展表明，这一"黄金分割点"正在释放出远超预期的创新能量。从单分子测序的基础突破到人工智能驱动的药物设计，从三靶点激动剂的临床前验证到产业化能力的快速提升，多肽技术正在从"药物分子的补充者"走向"治疗范式的引领者"。可以预见，随着基础研究、技术平台、临床开发和产业化的协同推进，多肽技术将在未来几年持续释放其巨大的科学价值和临床潜力，为人类健康事业作出更为重要的贡献。

2026-07-22

·BioSpace

Greenwich LifeSciences Announces Approval to Expand FLAMINGO-01 into the United Kingdom

STAFFORD, Texas, July 22, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the regulatory approval to expand FLAMINGO-01 into the United Kingdom. The Company's application to expand FLAMINGO-01 into the UK has been formally approved by UK regulators, thus adding potentially 5-10 geographically distributed UK sites to the approximately 170-180 approved sites in the US and Europe. The Company is collaborating with The Royal Marsden, a leading cancer research institute. Working with The Royal Marsden, we have been in discussions with many academic sites located in the following cities: London (multiple sites), Cambridge, Edinburgh, Oxford, Manchester, Southhampton, Cardiff, and potentially other cities. With regulatory approval, these start-up discussions will now move forward. The principal investigator at Royal Marsden, who will be serving as the UK national principal investigator, also plans to join the Steering Committee. CEO Snehal Patel commented, "We are very excited to be adding these UK sites from prominent research institutions. The initial introduction was driven by patient interest in the UK. Our hard work with The Royal Marsden in submitting our regulatory application has now paid off with our regulatory approval. The UK population of 70 million is one of the largest populations in Europe and we look forward to offering participation in FLAMINGO-01 to these patients." ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The Royal Marsden opened in 1851 as the world's first hospital dedicated to cancer diagnosis, treatment, research and education. Today it operates as a specialist cancer centre. Together with its principal academic partner, The Institute of Cancer Research, London, The Royal Marsden is designated as the UK's only National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) dedicated solely to cancer. The Royal Marsden and The Institute of Cancer Research (ICR) are recognised as one of the top four comprehensive cancer centres in the world for the impact of their research, influencing cancer treatment and care for all cancer patients. As a centre of excellence, they pioneer the very latest in cancer treatments and technologies, as well as leading the way in innovative cancer diagnosis and education. Based on 2019 and 2021-2022 data from Cancer Research UK, there are approximately 59,400 new breast cancer cases in the UK every year. Breast cancer is the most common cancer in females, which is 30% of all new female cancer cases. About FLAMINGO-01 Open Label Phase III Data More than 1,500 patients have been screened at a screen rate of approximately 600-800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection. In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate. The non-HLA-A*02 arm is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety pro non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company's website here . As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time. As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline. Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ. About GLSI-100 Phase IIb Study In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here : 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here . Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to:  flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/ neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime. In the US and Europe, there are approximately 700,000 new breast cancer patients per year and 9.5 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at and follow the Company's Twitter at . Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com

2026-07-21

·BioSpace

Greenwich LifeSciences Announces European Approval for Combining Both HLA Populations in FLAMINGO-01

July 16, 2026 -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01 in Europe. The Company previously announced that US clinical sites started enrolling both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA's review of such protocol changes, effectively more than doubling the enrollment rate of the pivotal arm of the study. Non-HLA-A*02patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment. The European Medicines Agency (EMA) has completed their review and will also allow the combination of both HLA-A*02 and non-HLA-A*02 patients in Europe. Thus, all 170-180 clinical sites in the US and Europe, are now operating under the same protocol and could continue enrolling up to the first interim analysis. Data can be analyzed by individual HLA types as well. Additional feedback is expected from UK and Canadian regulators. The Company plans to provide updates regarding the resulting improved trial design, including a pathway for the Company to now pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together potentially doubling the market for GP2 by accelerating the clinical development of the non-HLA-A*02 population. More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection. In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate. This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety pro non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company's website . As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time. As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline. Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ. In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows: 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally. One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法快速通道

100 项与 GLSI-100 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性乳腺癌	临床3期	美国	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	比利时	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	法国	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	德国	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	爱尔兰	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	意大利	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	波兰	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	葡萄牙	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	罗马尼亚	Greenwich LifeSciences, Inc.	2022-12-16
HER2阳性乳腺癌	临床3期	西班牙	Greenwich LifeSciences, Inc.	2022-12-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05232916 (Flamingo-01, ESMO_BC2026)	临床3期	乳腺癌辅助 HER2/neu positive \| HLA-A*02	498	GLSI-100	餘願襯糧艱廠窪鹽積願(製醖壓襯選願築壓憲鬱) = 顧膚願淵襯鑰選簾壓積憲膚蓋夢齋鏇積鏇顧鬱 (憲襯膚積鏇淵廠夢憲齋 ) 更多	积极	2026-05-07
				Placebo	餘願襯糧艱廠窪鹽積願(製醖壓襯選願築壓憲鬱) = 鹽積糧齋鑰簾繭製鹽鏇憲膚蓋夢齋鏇積鏇顧鬱 (憲襯膚積鏇淵廠夢憲齋 ) 更多
NCT05232916 (Flamingo-01, AACR2026)	临床3期	HER2/neu positive \| HLA-A*02	247	GLSI-100	衊築窪醖窪醖繭衊艱膚(膚壓憲襯糧窪遞糧簾構) = 願餘構獵觸壓憲願範淵餘顧襯膚壓鹹繭簾網鹹 (壓構夢鑰醖鑰築網鏇廠 ) 更多	积极	2026-04-20
NCT05232916 (FLAMINGO-01, Company_Website) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	250	GLSI-100	選獵願積憲醖觸積夢鬱(積築襯膚廠簾繭齋壓艱) = 製衊獵醖壓遞鹹觸簾築廠製簾築繭築鹹蓋網鏇 (壓鹹襯築獵願鑰製艱鏇 )	积极	2026-03-17
NCT05232916 (FLAMINGO-01, GlobeNewswire) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	-	GLSI-100 (HLA-A*02 patients)	夢餘憲製鑰積網繭鏇鹹(鑰製選糧廠糧構壓觸鹽) = The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A02 and non-HLA-A02 arms. 構衊窪艱糧鬱製窪製鏇 (獵觸淵襯選窪齋齋積衊 ) 更多	积极	2025-04-02
				GLSI-100 (non-HLA-A*02 patients)
NCT05232916 (FLAMINGO-01, Company_Website) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	-	GLSI-100	夢繭餘選鏇願壓願窪築(願衊窪鑰簾鏇糧鏇製壓) = 網觸簾願鹽糧醖簾淵糧壓膚繭壓繭選顧構夢鹽 (網鬱鑰襯鹹鹽衊襯遞餘 )	积极	2025-02-10
				Placebo	-
NCT05232916 (Flamingo-01, Company_Website) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	-	GLSI-100	網鑰醖糧夢憲範淵蓋鹹(鹹膚鏇醖繭製繭衊淵醖) = None 淵網築艱齋選襯顧製構 (齋範鑰製醖製願顧鑰糧 )	积极	2024-02-14
NCT00524277 (ASCO2022) 人工标引	临床2期	HER2阳性乳腺癌辅助 HER2 Positive	180	GLSI-100	夢窪築築齋憲艱夢窪範(齋觸蓋構廠築壓範積醖) = 廠蓋繭鬱鏇鑰鏇鑰鑰襯範艱鏇繭簾醖鑰簾選簾 (願選夢選鹽淵餘窪鏇構 )	积极	2022-06-02
				GM-CSF	夢窪築築齋憲艱夢窪範(齋觸蓋構廠築壓範積醖) = 憲構範選構製觸繭網鑰範艱鏇繭簾醖鑰簾選簾 (願選夢選鹽淵餘窪鏇構 )
NCT05232916 (Corporate Publications) 人工标引	临床2期	转移性乳腺癌 HER2 positive \| HER3 positive	180	GLSI-100	醖簾衊艱齋範選觸簾夢(製遞衊窪憲築憲窪製鹹) = 積積醖鏇繭艱鑰觸糧夢鏇壓衊鑰夢觸積繭艱醖 (觸鏇顧選範衊壓積憲艱 )	积极	2022-04-19
				GM-CSF	醖簾衊艱齋範選觸簾夢(製遞衊窪憲築憲窪製鹹) = 壓憲積鏇範餘艱獵構繭鏇壓衊鑰夢觸積繭艱醖 (觸鏇顧選範衊壓積憲艱 )
NCT00524277 (AACR2021) 人工标引	临床2期	HER2阳性乳腺癌 HER2 Positive	180	GM-CSF+GP2	鏇膚簾淵網鹹繭襯餘簾(醖築構淵鹽蓋簾壓壓鹹) = 窪蓋衊糧夢廠築選壓衊衊襯網艱築築廠鏇壓餘 (鹹淵餘膚鬱網選廠願鹹, 59.5 ~ 87.9) 更多	积极	2021-02-15
				GM-CSF	鏇膚簾淵網鹹繭襯餘簾(醖築構淵鹽蓋簾壓壓鹹) = 鹹醖鏇餘憲廠鏇餘鹽鬱衊襯網艱築築廠鏇壓餘 (鹹淵餘膚鬱網選廠願鹹, 60.1 ~ 88.2) 更多
GP2+GM-CSF (SABCS2016)	临床2期	乳腺癌辅助 HER2 3+	180	GP2+GM-CSF vaccine	網壓蓋衊夢鹽範簾鏇夢(衊顧夢構艱積蓋蓋夢夢) = 積淵鹽製糧願夢齋醖衊顧積築構願糧網夢網糧 (遞淵網遞遞願願製壓糧 ) 更多	不佳	2016-02-15
				GM-CSF alone	網壓蓋衊夢鹽範簾鏇夢(衊顧夢構艱積蓋蓋夢夢) = 窪衊齋蓋餘顧餘糧築構顧積築構願糧網夢網糧 (遞淵網遞遞願願製壓糧 ) 更多