STAFFORD, Texas, April 02, 2025 (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 following update on FLAMINGO-01 open label immune response data..

德克萨斯州斯塔福德，2025年4月2日（环球新闻社）——Greenwich LifeSciences, Inc.（纳斯达克：GLSI）（“公司”），一家专注于III期临床试验FLAMINGO-01的临床阶段生物制药公司，该试验正在评估免疫疗法GLSI-100以预防乳腺癌复发，今天宣布了以下关于FLAMINGO-01开放标签免疫反应数据的更新。

FLAMINGO-01 Immune Response Data Summary

FLAMINGO-01 免疫反应数据摘要

The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune response data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types (non- HLA-A*02), show that GLSI-100 is creating an immune response over time as the frequency of patients exhibiting an injection site reaction or GP2 Delayed-Type Hypersensitivity (DTH) skin test reaction as measured by induration or erythema is increasing with increased vaccinations..

公司已分析了FLAMINGO-01的初步免疫反应数据。在HLA-A*02治疗组、安慰剂组以及包含所有其他HLA类型（非HLA-A*02）的第三个开放标签组中，免疫反应数据显示，随着时间推移，GLSI-100正在引发免疫反应，因为随着疫苗接种次数增加，出现注射部位反应或GP2迟发型超敏反应（DTH）皮肤试验反应（通过硬结或红斑测量）的患者频率正在上升。

The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in

从基线到第四至第六个月的疫苗接种过程中，出现免疫反应的患者数量随着时间的推移而增加。

both

两者都

HLA-A*02 and non-HLA-A*02 arms.

HLA-A*02 和非 HLA-A*02 臂。

In addition, a baseline immune response to GP2 is being observed before any treatment with GP2 in

此外，在使用GP2进行任何治疗之前，正在观察对GP2的基线免疫反应。

both

两者都

HLA-A*02 and non-HLA-A*02 arms. This result suggests that GP2 is a natural antigen, that may have been part of an immune response in the patient during prior trastuzumab or other treatments.

HLA-A*02 和非 HLA-A*02 组。该结果表明 GP2 是一种天然抗原，可能在患者之前使用曲妥珠单抗或其他治疗期间已参与免疫反应。

These two general immune response findings, immune response at baseline and increasing immune response over time, were also observed in the Phase IIb clinical trial for HLA-A*02 only patients. These results confirm that the HLA prevalence, safety, and immune response in FLAMINGO-01 patients is trending as expected in both HLA arms..

这两项总体免疫反应的发现，即基线时的免疫反应和随着时间推移逐渐增强的免疫反应，也在仅针对HLA-A*02患者的IIb期临床试验中被观察到。这些结果证实，在FLAMINGO-01研究中，患者中的HLA分布、安全性和免疫反应在两个HLA组别中均呈现预期的趋势。

The Company recently filed patent claims for non-HLA-A*02 patients which may be solely owned by the Company separate from any prior license. These claims are also supported by binding prediction algorithms and in vitro binding experiments conducted by the Company. This represents an invention that was originated by the Company which could double the number of patients eligible for GP2 treatment to approximately 88,000 new patients per year in the US and Europe.

公司最近为非HLA-A*02患者提交了专利申请，该专利可能由公司单独拥有，与任何先前的许可无关。这些专利主张还得到了公司进行的结合预测算法和体外结合实验的支持。这项发明由公司原创，可使符合GP2治疗条件的患者数量增加一倍，达到每年在美国和欧洲大约新增88,000名患者。

The market potential using the drug prices per year of Kadcyla or Enhertu could be in the range of $8-10 billion per year..

使用Kadcyla或Enhertu每年的药物价格，市场潜力可能在每年80亿至100亿美元之间。

As mentioned in a prior press release, the non-HLA-A02 types that are most commonly being enrolled in FLAMINGO-01 include HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.

如之前新闻稿中所述，FLAMINGO-01 中最常见的非 HLA-A02 类型包括 HLA-A*03、HLA-A*24、HLA-A*01、HLA-A*11、HLA-A*68、HLA-A*29、HLA-A*30、HLA-A*23 和 HLA-A*33。

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label immune response data is based on the patients enrolled to date in FLAMINGO-01 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..

对来自FLAMINGO-01的开放标签数据的分析以保持研究盲态的方式进行。开放标签的免疫反应数据基于目前在FLAMINGO-01中入组的患者，因此属于初步数据。尽管可以将任何FLAMINGO-01的初步数据与IIb期临床试验数据进行比较，但这些初步结果并不能预测未来的结果，研究结束时的结果可能会有所不同。

CEO Snehal Patel commented, 'We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial.

首席执行官Snehal Patel评论道：“我们非常高兴地看到，FLAMINGO-01的初步结果显示，在HLA-A*02和非HLA-A*02患者中均产生了免疫反应。我们现在正在考虑为非HLA-A*02患者增加一个随机安慰剂组的优点，将当前这个开放标签的第三组转变为实质上的第二个关键且设盲的III期试验。”

If successful, the Company could pursue approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups with the potential to double the market for GP2 to up to $10 billion in revenue per year.'.

如果成功，公司可以寻求在相似的时间框架内对HLA-A*02和非HLA-A*02患者的同时批准，通过对两个患者组进行独立或联合分析，有可能将GP2的市场扩大一倍，每年收入高达100亿美元。

Mr. Patel added, 'The Company may choose to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of the T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response increases over time. Expansion into GP2 specific CAR-T cells could potentially become another platform technology to complement GP2 peptide treatment for non-responding higher risk patients.

帕特尔先生补充道：“公司可以选择通过在基线和GP2治疗后对T细胞的DNA进行测序，来扩展对GP2特异性T细胞的免疫反应分析。可以将T细胞序列与随时间增加的免疫反应进行比较。扩展到GP2特异性的CAR-T细胞有可能成为另一个平台技术，以补充针对无应答高风险患者的GP2肽段治疗。”

Blood samples have been collected at multiple timepoints for future T cell and immune response analysis.'.

已在多个时间点收集血液样本，用于未来的T细胞和免疫反应分析。

Previously Published Phase IIb Immune Response Data

之前发布的二期b阶段免疫反应数据

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.

在HLA-A*02乳腺癌患者的前瞻性、随机、单盲、安慰剂对照、多中心（由MD安德森癌症中心主导的16个试验点）IIb期临床试验中，46名HER2/neu 3+过表达患者接受了GLSI-100治疗，50名安慰剂组患者仅接受GM-CSF治疗。

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.

经过5年的随访，HER2/neu 3+患者在接受GLSI-100治疗后，癌症复发率降低了80%或更多，并且在最初的6个月内保持无病状态，我们认为这是达到峰值免疫力所需的时间，从而实现最大疗效和保护。

The Phase IIb results can be summarized as follows:.

二期b阶段的结果可以总结如下：。

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products

与其它获批产品降低20-50%的复发率相比，在五年的随访期内，转移性乳腺癌复发率降低了80%或更多。

Peak immune response at 6 months

6个月时达到免疫反应峰值

No reported serious adverse events attributable to treatment

没有报告因治疗引起的严重不良事件

Well-tolerated safety profile

耐受性良好的安全性概况

Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection.

在初级免疫系列（PIS）中完成了全程免疫，该系列包括在前6个月内接种的6次GLSI-100注射。通过局部皮肤测试和免疫学检测评估，PIS引发了强烈的免疫反应。此外，每6个月加强注射一次，延长了免疫反应时间，从而提供了更长期的保护。

In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100..

在IIb期和三个I期临床试验中，共有146名患者接受了治疗，GP2免疫疗法耐受性良好，且未报告与GLSI-100相关的严重不良事件。

The Phase IIb immune response data in HLA-A*02 only patients was published at AACR in 2021 with the following findings:

HLA-A*02阳性患者的IIb期免疫应答数据于2021年在AACR上发表，研究结果如下：

GP2 immunotherapy generated GP2-specific immune responses leading to promising clinical benefit, thus supporting GP2’s mechanism of action.

GP2免疫治疗引发了GP2特异性的免疫反应，带来了可观的临床效益，从而验证了GP2的作用机制。

Immune responses to GP2 were measured over time using a CD8 T cell dimer binding assay (Dimer Binding Assay) and GP2 DTH skin tests. GP2 immunity peaked at 6 months in HER2 3+ patients after they completed their first 6 immunizations, as measured by the Dimer Binding Assay. The data also shows that for the 2.5 years that the immune response was measured, the immunity was sustained and remained above baseline, resulting in a reduction in metastatic breast cancer recurrences..

使用CD8 T细胞二聚体结合试验（Dimer Binding Assay）和GP2迟发型超敏反应（DTH）皮肤测试，随时间测量了对GP2的免疫反应。通过二聚体结合试验测量，HER2 3+患者在完成前6次免疫后，GP2免疫力在6个月时达到峰值。数据还显示，在测量免疫反应的2.5年中，免疫力得以维持并保持在基线水平之上，从而减少了转移性乳腺癌的复发。

Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat low HER2 and other HER2 1-3+ expressing cancers in combination with trastuzumab or trastuzumab antibody drug conjugates.

广泛的基础免疫反应表明，GP2免疫疗法和基于赫赛汀的产品可能还具有与曲妥珠单抗或曲妥珠单抗抗体药物结合使用治疗低HER2及其他HER2 1-3+表达癌症的潜力。

About FLAMINGO-01 and GLSI-100

关于FLAMINGO-01和GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of 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.

FLAMINGO-01（NCT05232916）是一项III期临床试验，旨在评估GLSI-100（GP2 + GM-CSF）在HER2阳性乳腺癌患者中的安全性和有效性。这些患者在手术时有残留病灶或高风险病理完全缓解，并已完成新辅助治疗和术后基于曲妥珠单抗的辅助治疗。

The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm.

该试验由贝勒医学院主导，目前包括来自基于大学的医院和合作网络的美国临床站点，并计划扩展到欧洲，并在全球开设多达150个站点。在III期试验的双盲部分，大约500名HLA-A*02患者将被随机分配到GLSI-100或安慰剂组，而在第三个试验组中，多达250名其他HLA类型的患者将接受GLSI-100治疗。

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..

试验设计用于检测侵袭性乳腺癌无病生存期的风险比为0.3，需要28例事件。当至少一半的事件（即14例）发生时，将进行一次中期优效性和无效性分析。如果安慰剂组受试者的年事件发生率为2.4%或更高，该样本量可提供80%的检验效能。

For more information on FLAMINGO-01, please visit the Company's website

有关FLAMINGO-01的更多信息，请访问公司网站。

here

这里

and clinicaltrials.gov

和 clinicaltrials.gov

here

这里

. 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:

可以在“联系方式和地点”部分查看大多数参与临床试验的站点的联系信息和交互式地图。请注意，交互式地图在移动设备屏幕上无法查看。相关问题和参与兴趣可通过电子邮件发送至：

flamingo-01@greenwichlifesciences.com

火烈鸟-01@格林威治生命科学公司.com

About Breast Cancer and HER2/

关于乳腺癌和HER2/

neu

新

Positivity

积极性

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..

在美国，八分之一的女性在其一生中会患上浸润性乳腺癌，大约有 30 万名新乳腺癌患者和 400 万名乳腺癌幸存者。HER2（人类表皮生长因子受体 2）蛋白是一种细胞表面受体蛋白，常见于多种癌症中表达，包括 75% 的乳腺癌，其表达水平分为低（1+）、中（2+）和高（3+ 或过度表达）。

About Greenwich LifeSciences, Inc.

关于格林威治生命科学公司

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.

格林威治生命科学是一家临床阶段的生物制药公司，专注于开发GP2，这是一种免疫疗法，旨在预防曾经接受过手术的乳腺癌患者复发。GP2是HER2蛋白的一个9个氨基酸的跨膜肽，HER2是一种细胞表面受体蛋白，在多种常见癌症中表达，包括75%的乳腺癌在低（1+）、中（2+）和高（3+或过度表达）水平表达。

Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at .

格林威治生命科学公司已开始进行第三期临床试验，FLAMINGO-01。欲了解有关格林威治生命科学公司的更多信息，请访问该公司的网站。

www.greenwichlifesciences.com

www.greenwichlifesciences.com

and follow the Company's Twitter at

并关注公司的Twitter

https://twitter.com/GreenwichLS

https://twitter.com/GreenwichLS

.

。

Forward-Looking Statement Disclaimer

前瞻性声明免责声明

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.

本新闻稿中的声明包含“前瞻性声明”，这些声明受重大风险和不确定性影响。本新闻稿中除历史事实陈述外的所有声明均为前瞻性声明。本新闻稿中的前瞻性声明可以通过使用诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“预计”、“意图”、“寻求”、“或许”、“也许”、“计划”、“潜在”、“预测”、“预计”、“目标”、“瞄准”、“应该”、“将”、“会”或这些词语的否定形式或其他类似表达来识别，尽管并非所有前瞻性声明都包含这些词语。

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.

前瞻性声明基于格林威治生命科学公司的当前预期，并受制于难以预测的固有不确定性、风险和假设，包括关于公开发行净收益的预期用途的声明；因此，实际结果可能与这些前瞻性声明中明示或暗示的结果存在重大差异。

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 Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission.

此外，某些前瞻性声明是基于对未来事件的假设，而这些假设可能被证明不准确。这些风险和其他不确定性在格林威治生命科学公司2023年12月31日年度报告的10-K表格中的“风险因素”部分以及提交给证券交易委员会的其他定期报告中有更全面的描述。

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..

本公告中包含的前瞻性声明是截至本日期作出的，Greenwich LifeSciences, Inc. 除适用法律要求外，不承担更新此类信息的义务。

Company Contact

公司联系方式

Snehal Patel

斯内哈尔·帕特尔

Investor Relations

投资者关系

Office: (832) 819-3232

办公室电话：（832）819-3232

Email:

电子邮件：

info@greenwichlifesciences.com

info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences

格林威治生命科学公司的投资者和公共关系联系人

Dave Gentry

戴夫·根特里

RedChip Companies Inc.

红筹公司

Office: 1-800-RED CHIP (733 2447)

办公室：1-800-RED CHIP（733 2447）

Email:

电子邮件：

dave@redchip.com

戴夫@红芯片.公司