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2022-08-11

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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项与 GLSI-100 相关的文献（医药）

2008-12-01·Cancer immunology, immunotherapy : CII2区 · 医学

Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02

2区 · 医学

Article

作者: Yusuf H. Jama ; Sathibalan Ponniah ; Dianna Craig ; Matthew T. Hueman ; Asna Amin ; Jeremy D. Gates ; Linda C. Benavides ; Catherine E. Storrer ; Alex Stojadinovic ; Jarrod P. Holmes ; George E. Peoples ; Elizabeth A. Mittendorf ; Mark G. Carmichael

BACKGROUND:

E75, a HER2/neu immunogenic peptide, is expressed in breast cancer (BCa). We have performed clinical trials of E75 + GM-CSF vaccine in disease-free, node-positive and node-negative BCa patients at high recurrence risk and recurrences were noted in both control and vaccine groups.

METHODS:

Among the 186 BCa patients enrolled, 177 completed the study. Patients were HLA typed; the HLA-A2(+)/A3(+) patients were vaccinated; HLA-A2(-)/A3(-) patients were followed as controls. Standard clinicopathological factors, immunologic response to the vaccine, and recurrences were collected and assessed.

RESULTS:

The control group recurrence rate was 14.8 and 8.3% in the vaccinated group (P = 0.17). Comparing the 8 vaccinated recurrences (V-R) to the 88 vaccinated nonrecurrent patients (V-NR), the V-R group had higher nodal stage (> or = N2: 75 vs. 5%, P = 0.0001) and higher grade tumors (%grade 3: 88 vs. 31%, P = 0.003). The V-R group did not fail to respond immunologically as noted by equivalent dimer responses and post-DTH responses. Compared to control recurrent patients (C-R), V-R patients trended toward higher-grade tumors and hormone-receptor negativity. C-R patients had 50% bone-only recurrences, compared to V-R patients with no bone-only recurrences (P = 0.05). Lastly, V-R mortality rate was 12.5% compared with 41.7% for the C-R group (P = 0.3).

CONCLUSIONS:

The vaccinated patients who recurred had more aggressive disease compared to V-NR patients. V-R patients had no difference in immune response to the vaccine either in vitro or in vivo. V-R patients, when compared to C-R patients, trended towards more aggressive disease, decreased recurrence rates, decreased mortality, and no bone-only recurrences.

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.

项与 GLSI-100 相关的新闻（医药）

2026-02-24

·BioSpace

Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026

STAFFORD, Texas, Feb. 24, 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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, including two corresponding posters. The AACR 2026 conference will be held from April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference. CEO Snehal Patel commented, "One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01." About the AACR Annual Meeting 2026 The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world. About FLAMINGO-01 Open Label Phase III Data More than 1,000 patients have been screened with a current screen rate of approximately 600 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 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. 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 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. 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 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. 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, 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. 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, 2024, 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

临床2期免疫疗法临床3期快速通道临床结果

2026-01-30

·中肽生化

行业研究 | 2026年值得关注的中美多肽药物关键临床一览

｜中肽生化内容团队编辑在经历了跌宕起伏的2025年后，多肽药物开发在2026年又将迎来一批后期临床的“到彼岸”。本文选取在clinicaltrials.gov上注册，在中国或美国进行的3，4期多肽药物的临床试验，它们将于2026年实现主要终点的完成。所涉适应症涵盖遗传性生长障碍、代谢与肥胖相关疾病、肿瘤辅助或免疫治疗、内分泌功能紊乱、炎症与自身免疫疾病，以及分子影像诊断等多个彼此独立的临床场景。多肽药物：Vosoritide 开发商：BioMarin 适应症：Hypochondroplasia (轻型软骨发育不全) 临床：NCT06455059 ，（CANOPY-HCH-3 ）3期 Primary Completion: 2026-08-01 这项 III 期临床研究（NCT06455059）聚焦于轻型软骨发育不全（Hypochondroplasia）这一由 FGFR3 激活突变驱动的遗传性骨骼发育障碍，评估 Vosoritide 作为疾病干预手段的疗效与安全性。Vosoritide 是一种 C 型利钠肽（CNP）类似物，通过激活 NPR-B（NPR2）–cGMP 信号通路，在生长板软骨细胞中功能性对冲 FGFR3 过度信号，从而改善内软骨成骨过程；这一机制已在同一通路相关的骨骼发育障碍中建立了明确的生物学合理性。此前的 II 期研究显示，在经基因检测确诊的 HCH 儿童中，vosoritide 治疗可带来相较基线具有一致方向性的年化生长速度（AGV）改善，且整体安全性特征与其既往在 FGFR3 相关疾病中的经验相符，为进入确证性研究奠定了基础。在此背景下，CANOPY-HCH-3 采用随机、分层、安慰剂对照、双盲、多中心设计，对从既往研究滚入的儿童患者进行 52 周每日皮下注射治疗，以 AGV 作为主要终点，系统验证该机制导向的多肽治疗能否在 HCH 人群中转化为稳定、可重复的临床获益。研究由 BioMarin Pharmaceutical赞助，代表其在 FGFR3 相关罕见骨骼发育障碍领域对既有平台的进一步拓展。多肽药物： GLSI-100（GP2 + GM-CSF）开发商： Greenwich LifeSciences, Inc. 适应症： HER2/Neu 阳性乳腺癌（高复发风险、完成新辅助及辅助治疗后人群）临床阶段： III 期（FLAMINGO-01，NCT05232916） Primary Completion： 2026-12 这项 III 期临床研究（FLAMINGO-01，NCT05232916）评估 GLSI-100 在 HER2/Neu 阳性乳腺癌高复发风险人群中的疗效与安全性。GLSI-100 是一种多肽肿瘤疫苗型免疫治疗，由 HER2/Neu 衍生肽 GP2 联合 GM-CSF 佐剂构成，其靶点为 HER2 蛋白跨膜区表位，设计目标是在完成新辅助治疗及术后辅助曲妥珠单抗为基础标准治疗后，通过诱导HER2 特异性 CD8⁺ T 细胞免疫反应，降低残余病灶或高复发风险患者的复发概率。既往 II 期研究在 HLA-A*02 阳性、HER2 阳性乳腺癌患者中显示，GLSI-100 可诱导持久的抗原特异性免疫应答，并在部分亚组中观察到无病生存期（DFS）改善趋势，且安全性良好，主要不良反应为注射部位反应和轻度全身免疫相关症状。在此基础上，FLAMINGO-01 采用前瞻性、随机、双盲、安慰剂对照、多中心设计，计划入组约 750 例 HER2 阳性受试者，主要研究人群为 HLA-A*02 阳性患者，同时设置第三个开放标签队列探索非 HLA-A*02 阳性人群的免疫治疗潜力。研究旨在系统验证该 HER2 靶向多肽疫苗策略是否能够在高复发风险人群中转化为具有临床意义的长期结局改善。多肽药物： PJ009 开发商： Chongqing Peg-Bio Biopharm Co., Ltd.（重庆派金生物科技）适应症： Short Bowel Syndrome（短肠综合征）；临床阶段： III 期（NCT06512584，CQPJ-PJ009-III） Primary Completion： 2026-03-30 这项 III 期临床研究（NCT06512584）评估 PJ009 在短肠综合征（Short Bowel Syndrome，SBS）且需长期肠外营养支持患者中的疗效与安全性。治疗方案为按体重每日皮下注射，核心评估围绕肠外营养依赖程度的变化及整体安全性展开，验证 PJ009 是否能够在 SBS 人群中带来具有临床意义的营养支持负担改善。多肽药物： 68Ga-PSMA-11 开发商： Telix Pharmaceuticals (Innovations) Pty Limited 适应症：前列腺癌（Prostate Cancer，影像学检测）临床阶段： III 期（NCT07052214） Primary Completion： 2026-06 这项 III 期研究评估 68Ga-PSMA-11 PSMA PET 联合 MRI (磁共振成像) 相较标准诊疗路径在前列腺癌检测中的诊断价值。研究以 PSMA 靶向多肽放射性配体成像为核心，通过与 MRI 结果联合指导系统性及靶向活检，旨在提高临床显著性前列腺癌的检出率并减少不必要的活检。多肽药物： Avexitide 开发商： Amylyx Pharmaceuticals Inc. 适应症： Post-Bariatric Hypoglycemia（术后低血糖，Roux-en-Y 胃旁路术后）临床阶段： III 期（NCT06747468，LUCIDITY / AVX-001） Primary Completion： 2026-03 这项 III 期临床研究（LUCIDITY，NCT06747468）评估 Avexitide 在减重手术后低血糖（Post-Bariatric Hypoglycemia，PBH）患者中的疗效与安全性。PBH 常见于 Roux-en-Y 胃旁路术（RYGB）后，其核心病理与术后 GLP-1 信号异常增强、继发高胰岛素反应密切相关。Avexitide 为一款 GLP-1 受体拮抗多肽，通过抑制过度的 GLP-1 介导信号，减少餐后胰岛素峰值，从而降低低血糖事件发生频率。该研究由 Amylyx Pharmaceuticals Inc. 赞助，验证这一机制导向的多肽拮抗策略是否能够为 PBH 提供稳定、可长期使用的药物治疗方案。多肽药物： iGlarLixi（insulin glargine + lixisenatide）开发商： Sanofi 适应症： 2 型糖尿病（T2D，口服降糖药控制不佳的中国初治胰岛素人群）临床阶段： IV 期（NCT06671587，China Soli-CGM / LPS18034） Primary Completion： 2026-09-18 这项 IV 期、多中心、随机、开放标签研究（China Soli-CGM，NCT06671587）比较 iGlarLixi 与胰岛素甘精 U100（Gla-100）在中国口服降糖药治疗失败的 2 型糖尿病患者中的血糖控制效果。研究以连续血糖监测（CGM）测得的血糖达标时间（TIR）变化为主要终点，评估在真实世界治疗路径中，将基础胰岛素与 GLP-1 受体激动剂（lixisenatide）组合是否能够在不增加治疗复杂度的前提下，带来更优的整体血糖稳定性。研究结果将为固定复方注射制剂在中国 T2D 人群中的临床定位与使用策略提供循证依据。多肽药物： CagriSema（cagrilintide + semaglutide）开发商： Novo Nordisk A/S 适应症： 2 型糖尿病（T2D，已使用二甲双胍和/或 SGLT2 抑制剂但控制不佳）临床阶段： III 期（NCT06534411，REIMAGINE 5） Primary Completion： 2026-06-02 这项 III 期随机对照研究（REIMAGINE 5）比较 CagriSema 与 Tirzepatide 在 2 型糖尿病患者中的降糖与减重效果。CagriSema 为 cagrilintide（胰淀素类似物）与 semaglutide（GLP-1 受体激动剂）的联合给药方案，研究采用每周一次皮下注射，评估其在标准口服降糖治疗基础上的血糖控制和体重改善潜力。该研究计划定位于与双/多靶点肠促胰素类药物的头对头比较，为 CagriSema 在 T2D 治疗中的临床价值提供直接对照证据。多肽药物： CagriSema（cagrilintide + semaglutide）开发商： Novo Nordisk A/S 适应症： 2 型糖尿病（T2D，二甲双胍治疗后控制不佳，可合并或不合并 SGLT2 抑制剂）临床阶段： III 期（NCT06221969） Primary Completion： 2026-02-20 这项 III 期随机对照研究（NCT06221969）比较 CagriSema（cagrilintide + semaglutide，2.4 mg/2.4 mg，每周一次皮下注射）与 Tirzepatide（15 mg，每周一次）在 2 型糖尿病患者中的降糖与减重效果。研究入组约 1,000 例在二甲双胍基础治疗下血糖控制不佳的患者，允许合并或不合并 SGLT2 抑制剂，核心在于通过胰淀素通路（cagrilintide）与 GLP-1 通路（semaglutide）的联合调控，评估其相较多靶点肠促胰素药物的临床获益幅度，为 CagriSema 在 T2D 治疗中的定位提供直接头对头证据。多肽药物： Tirzepatide 开发商： Eli Lilly 适应症： 2 型糖尿病（T2D，斋月禁食期间用药管理）临床阶段： IV 期（NCT06635057） Primary Completion： 2026-04 这项 IV 期、多中心、多国家、开放标签、单臂研究（T-RAM，NCT06635057）评估 Tirzepatide 在斋月禁食背景下启动并按说明书用药的有效性与安全性。研究关注在禁食—进食节律显著改变的情境中，每周一次给药的 GLP-1/GIP 双受体激动多肽是否能够维持稳定的血糖控制并避免低血糖风险，为穆斯林 T2D 人群在斋月期间的真实世界用药策略提供循证依据。多肽药物： Tirzepatide 开发商： Eli Lilly 适应症：青少年肥胖或超重（伴至少一种体重相关合并症）临床阶段： III 期（NCT06075667） Primary Completion： 2026-05 这项 III 期随机、双盲、安慰剂对照研究（NCT06075667）评估 Tirzepatide 在青少年肥胖或超重合并症人群中的疗效、安全性与药代动力学。研究采用每周一次给药方案，在生活方式干预基础上比较其相较安慰剂的体重改善效果，并设置长期延伸治疗以评估持续用药的安全性与维持效应，为 GLP-1/GIP 双受体激动多肽在青少年体重管理中的临床应用提供确证性证据。多肽药物： Tirzepatide 开发商： Eli Lilly 适应症：肥胖或超重（伴体重相关合并症，体重减轻后的维持治疗）临床阶段： III 期（Phase 3b）（NCT06047548） Primary Completion： 2026-05 这项 III 期（Phase 3b）随机对照研究（SURMOUNT-MAINTAIN，NCT06047548）评估 Tirzepatide 在完成初始体重下降后的体重维持阶段的疗效与安全性。研究设计为先进行 60 周开放标签减重期，在达到随机条件后进入 52 周双盲维持期，比较固定低剂量（5 mg）或最大耐受剂量（MTD）的 tirzepatide 与安慰剂在维持既有体重减轻效果方面的差异。该研究重点回答 GLP-1/GIP 双受体激动多肽是否能够在长期治疗中稳定维持减重获益，为肥胖的慢病化、长期管理策略提供循证依据。多肽药物： Retatrutide 开发商： Eli Lilly 适应症：肥胖症临床阶段： III 期（NCT06662383） Primary Completion： 2026-12 这项 III 期随机、双盲研究（NCT06662383）头对头比较 Retatrutide 与 Tirzepatide 在成人肥胖人群中的疗效与安全性。Retatrutide 为 GLP-1/GIP/胰高血糖素三受体激动多肽，在 GLP-1/GIP 双通路基础上引入胰高血糖素通路调控，旨在进一步增强能量消耗与体重下降幅度；Tirzepatide 则作为已建立临床基准的 GLP-1/GIP 双受体激动多肽作为直接对照。研究计划入组约 800 例受试者，治疗随访约 89 周，定位于评估三重肠促胰素策略是否能够在肥胖治疗中实现相较现有双靶点方案的增量获益。多肽药物： Inpegsomatropin 开发商： Xiamen Amoytop Biotech Co., Ltd. 适应症：特发性矮小（Idiopathic Short Stature，ISS）临床阶段： III 期（NCT06927310，PEGPESEN-4-2-001） Primary Completion： 2026-03 这项 III 期、多中心、随机、开放标签、阳性对照研究（NCT06927310）比较 Inpegsomatropin 与重组人生长激素（rhGH）在特发性矮小（ISS）儿童中的疗效与安全性。Inpegsomatropin为经 PEG 修饰的人生长激素多肽，采用每周一次皮下注射给药方案，研究以 52 周治疗期为核心，评估其在促进线性生长方面是否能够达到或接近每日给药 rhGH 的疗效，同时验证长效给药在依从性与长期安全性方面的潜在优势。多肽药物： JNJ-77242113 (Icotrokinra) 开发商：J&J 适应症：中重度斑块型银屑病（Plaque Psoriasis）临床阶段： III 期（NCT06934226，ICONIC-ASCEND） Primary Completion： 2026-03-30 这项 III 期、多中心、随机、双盲研究（ICONIC-ASCEND，NCT06934226）比较 JNJ-77242113 (Icotrokinra) 与安慰剂及 Ustekinumab 在中重度斑块型银屑病患者中的疗效与安全性。JNJ-77242113 是一款口服 IL-23 受体拮抗多肽，通过阻断 IL-23/IL-23R 通路抑制 Th17 相关炎症反应；Ustekinumab 作为 IL-12/IL-23 单抗提供成熟生物制剂对照。研究旨在验证口服多肽直接拮抗受体的策略，是否能够在保持生物学疗效的同时，提供不同于注射抗体的给药便利性与长期管理潜力。多肽药物： Cyclosporine（眼用凝胶）赞助商： Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. 适应症：中至重度干眼病（Dry Eye Disease）临床阶段： III 期（NCT06766357） Primary Completion： 2026-02 这项 III 期、多中心、随机、双盲、载体对照研究（NCT06766357）评估环孢素（Cyclosporine）眼用凝胶在中至重度干眼病患者中的疗效与安全性。Cyclosporine 是一款环状十一肽免疫抑制剂，通过抑制钙调神经磷酸酶（calcineurin），下调 T 细胞介导的炎症反应，从而改善干眼相关的炎症病理。研究以 84 天双盲治疗期作为主要疗效分析阶段，随后进入开放用药的安全性观察期，旨在验证局部多肽免疫调节策略在中重度干眼治疗中的临床价值与耐受性。

临床3期临床2期疫苗免疫疗法临床终止

2026-01-27

·BioSpace

Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

STAFFORD, Texas, Jan. 27, 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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its cash burn rate and financing strategy. The Company's ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for 2025 exceeded the Company's 2025 cash burn rate of approximately $9.5 million, leading to a year end cash balance of approximately $6 million as of December 31, 2025. Furthermore, the Company more than doubled its cash balance as of the close of business on January 23, 2026, to approximately $12.5 million, having raised approximately $7 million in the first three weeks of January 2026 through the ATM. The above preliminary financial figures are unaudited and are subject to change following completion of the Company's financial audit for 2025. CEO Snehal Patel commented, "Our financing strategy in January 2026 has been quite impressive so far without daily or constant use of the ATM. The current cash balance of $12.5 million could exceed the Company's cash needs for all of 2026, given the $9.5 million annual burn rate in 2025 and the modest increase in cash needs over the $7 million annual burn rates in 2024 and 2023. We believe the Company's lean structure and ongoing cost saving initiatives have been instrumental in this strategy, including the increasing number of patients entering the less expensive booster phase of Flamingo-01, due to less frequent site visits and vaccinations, and fewer more expensive site start-up costs." Mr. Patel further added, "While our cash burn rates in 2026 and 2027 are projected to increase, the expected ongoing use of the ATM to sustain or grow the current cash balance may reduce the likelihood of the Company doing a large near term financing in 2026 or 2027, though there can be no assurance of this. Since the follow-on offering in 2020, we primarily utilized the ATM with initially Jefferies and more recently H.C. Wainwright to fund the Company. Continued use of the ATM may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities." About FLAMINGO-01 Open Label Phase III Data More than 1,000 patients have been screened with a current screen rate of approximately 600 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 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. 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 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. 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 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. 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, 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. 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, 2024, 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

临床2期临床结果免疫疗法临床3期快速通道

100 项与 GLSI-100 相关的药物交易

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研发状态

10 条进展最快的记录,

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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.	2022-08-11
HER2阳性乳腺癌	临床3期	法国	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	德国	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	爱尔兰	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	意大利	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	波兰	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	罗马尼亚	Greenwich LifeSciences, Inc.	2022-08-11
HER2阳性乳腺癌	临床3期	西班牙	Greenwich LifeSciences, Inc.	2022-08-11
淋巴结阳性乳腺癌	临床2期	美国	Greenwich LifeSciences, Inc.	2007-01-01
淋巴结阳性乳腺癌	临床2期	美国	NuGenerex Immuno-Oncology, Inc.	2007-01-01

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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, GlobeNewswire) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	-	GLSI-100 (HLA-A*02 patients)	糧繭構選觸獵願鑰糧鹹(繭艱鏇簾鏇簾衊蓋憲淵) = 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. 艱遞衊網壓簾膚獵鬱鑰 (夢糧鏇壓鹹選遞壓獵遞 ) 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	鹽願遞築選醖網餘廠艱(鬱築醖糧壓選夢鏇齋鑰) = 膚選窪選淵鏇鹽觸醖遞糧鹹顧廠艱蓋憲鬱網構 (觸窪夢製網憲廠廠鹹築 )	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	夢廠憲獵積蓋遞遞夢顧(網製構夢壓簾網淵繭醖) = None 繭衊觸窪繭廠築艱遞遞 (鬱築繭觸網齋齋窪襯製 )	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	遞構襯廠製淵壓壓憲膚(製衊壓網願繭廠鏇鹹簾) = 構糧醖願遞鏇壓鹽憲網襯積鏇齋製醖範網壓壓 (願夢膚觸製鏇蓋淵構糧 )	积极	2022-06-02
				GM-CSF	遞構襯廠製淵壓壓憲膚(製衊壓網願繭廠鏇鹹簾) = 構窪顧齋衊醖鹽醖膚選襯積鏇齋製醖範網壓壓 (願夢膚觸製鏇蓋淵構糧 )
NCT05232916 (Corporate Publications) 人工标引	临床2期	转移性乳腺癌 HER2 positive \| HER3 positive	180	GLSI-100	窪衊簾遞蓋鏇襯製觸憲(衊壓鑰衊繭鹽夢衊衊醖) = 繭顧繭顧鏇淵淵餘範餘鹹膚選獵憲範構鏇壓構 (憲遞餘網範壓鏇蓋鑰鏇 )	积极	2022-04-19
				GM-CSF	窪衊簾遞蓋鏇襯製觸憲(衊壓鑰衊繭鹽夢衊衊醖) = 糧簾範築夢鏇範繭製廠鹹膚選獵憲範構鏇壓構 (憲遞餘網範壓鏇蓋鑰鏇 )
NCT00524277 (AACR2021) 人工标引	临床2期	HER2阳性乳腺癌 HER2 Positive	180	GM-CSF+GP2	衊膚窪壓製簾鹽鑰願窪(齋鹹壓鏇艱餘膚壓艱糧) = 簾鹹憲鹽衊衊衊鏇構積網憲網廠憲窪鏇願願製 (繭選襯艱願鬱醖觸醖衊, 59.5 ~ 87.9) 更多	积极	2021-02-15
				GM-CSF	衊膚窪壓製簾鹽鑰願窪(齋鹹壓鏇艱餘膚壓艱糧) = 築鹽願網鹹蓋鏇範鹹範網憲網廠憲窪鏇願願製 (繭選襯艱願鬱醖觸醖衊, 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	簾憲鬱夢範獵簾選餘構(齋遞構膚簾簾選築醖艱) = 遞鹹窪選遞構簾淵觸積憲觸遞繭夢製壓選觸築 (艱鹹廠鹹鑰憲糧餘糧築 ) 更多	不佳	2016-02-15
				GM-CSF alone	簾憲鬱夢範獵簾選餘構(齋遞構膚簾簾選築醖艱) = 襯積構膚築淵構襯鏇選憲觸遞繭夢製壓選觸築 (艱鹹廠鹹鑰憲糧餘糧築 ) 更多