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) - GLSI-21-01

Start Date19 Mar 2024

Sponsor / Collaborator

Greenwich LifeSciences, Inc.

NCT05232916 / RecruitingPhase 3

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.

Start Date11 Aug 2022

Sponsor / Collaborator

Greenwich LifeSciences, Inc.

NCT03014076 / CompletedPhase 1

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

Start Date01 Jan 2008

Sponsor / Collaborator

LumaBridge LLCStartup

100 Clinical Results associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

100 Translational Medicine associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

100 Patents (Medical) associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

Literatures (Medical) associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

01 Nov 2024·Journal for ImmunoTherapy of Cancer

Magnitude of antigen-specific T-cell immunity the month after completing vaccination series predicts the development of long-term persistence of antitumor immune response

Article

Author: Reichow, Jessica L ; Stanton, Sasha E ; Lim, Jong-Baeck ; Dai, James Y ; Hitchcock-Bernhardt, Katie M ; Disis, Mary L ; Liao, John B ; Gooley, Theodore A ; Salazar, Lupe G

Background:

For best efficacy, vaccines must provide long-lasting immunity. To measure longevity, memory from B and T cells are surrogate endpoints for vaccine efficacy. When antibodies are insufficient for protection, the immune response must rely on T cells. The magnitude and differentiation of effective, durable immune responses depend on antigen-specific precursor frequencies. However, development of vaccines that induce durable T-cell responses for cancer treatment has remained elusive.

Methods:

To address long-lasting immunity, patients with HER2+ (human epidermal growth factor receptor 2) advanced stage cancer received HER2/neu targeted vaccines. Interferon-gamma (IFN-γ) enzyme-linked immunosorbent spot measuring HER2/neu IFN-γ T cells were analyzed from 86 patients from three time points: baseline, 1 month after vaccine series, and long-term follow-up at 1 year, following one in vitro stimulation. The baseline and 1-month post-vaccine series responses were correlated with immunity at long-term follow-up by logistic regression. Immunity was modeled by non-linear functions using generalized additive models.

Results:

Antigen-specific T-cell responses at baseline were associated with a 0.33-log increase in response at long-term follow-up, 95% CI (0.11, 0.54), p=0.003. 63% of patients that had HER2/neu specific T cells at baseline continued to have responses at long-term follow-up. Increased HER2/neu specific T-cell response 1 month after the vaccine series was associated with a 0.47-log increase in T-cell response at long-term follow-up, 95% CI (0.27, 0.67), p=2e-5. 74% of patients that had an increased IFN-γ HER2 response 1 month after vaccines retained immunity long-term. As the 1-month post-vaccination series precursor frequency of HER2+IFN-γ T-cell responses increased, the probability of retaining these responses long-term increased (OR=1.49 for every one natural log increase of precursor frequency, p=0.0002), reaching an OR of 20 for a precursor frequency of 1:3,000

Conclusions:

Patients not destined to achieve long-term immunity can be identified immediately after completing the vaccine series. Log-fold increases in antigen-specific precursor frequencies after vaccinations correlate with increased odds of retaining long-term HER2 immune responses. Further vaccine boosting or immune checkpoint inhibitors or other immune stimulator therapy should be explored in patients that do not develop antigen-specific T-cell responses to improve overall response rates.

01 Aug 2023·Journal of Cancer Research and Clinical Oncology

HER2/neu-based vaccination with li-Key hybrid, GM-CSF immunoadjuvant and trastuzumab as a potent triple-negative breast cancer treatment

Review

Author: Zhou, Yihan

Abstract:

Purpose:

Constituting 15 to 20% of breast cancer cases, the triple-negative subtype lacks effective treatments as being less responsive to hormone-associated therapies. Alternatively, a more powerful immunotherapeutic vaccination can trigger immune recognition and destruction against breast cancer by incorporating oncological antigens such as human epidermal growth factor receptor 2 (HER2/neu). Currently, HER2/neu-based vaccines have finished three phases with breast cancer patients, in conjunction with granulocyte-macrophage colony-stimulating factor (GM-CSF) that was proven to be a promising vaccine adjuvant in other cancer trials previously.

Methods:

Completed HER2/neu-based vaccine trials with GM-CSF immunoadjuvants for breast cancer were summarised, and additionally, the article discussed prominent findings of vaccine effectiveness in triple-negative breast cancer, regarding li-Key hybrid in vaccine design and co-administration of anti-HER2/neu trastuzumab.

Results:

Nine clinical trials of three HER2/neu epitopes, one with li-Key hybrid, were analysed with or without the presence of trastuzumab. Immunological responses and minimal toxicities were observed in these epitopes, and disease-free survival was especially improved in the triple-negative population.

Conclusion:

HER2/neu-based peptide vaccine is a safe and effective approach against breast cancer, and its benefits can be potentially furthered by combining the li-Key hybrid vaccine with targeted drugs and adjuvants selected to enhance cross-presentation for exogenous vaccine antigens.

Graphical abstract:

01 Jan 2022·International journal of cancer

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

Article

Author: Squeo, Gabriella C. ; Olson, Walter C. ; Chianese‐Bullock, Kimberly A. ; Kane, William J. ; Foley, Eugene F. ; Friel, Charles M. ; Slingluff, Craig L. ; Meneveau, Max O. ; Petroni, Gina ; Lynch, Kevin T.

Abstract:

Checkpoint‐blockade therapy (CBT) is approved for select colorectal cancer (CRC) patents, but additional immunotherapeutic options are needed. We hypothesized that vaccination with carcinoembryonic antigen (CEA) and Her2/neu (Her2) peptides would be immunogenic and well tolerated by participants with advanced CRC. A pilot clinical trial (NCT00091286) was conducted in HLA‐A2+ or ‐A3+ Stage IIIC‐IV CRC patients. Participants were vaccinated weekly with CEA and Her2 peptides plus tetanus peptide and GM‐CSF emulsified in Montanide ISA‐51 adjuvant for 3 weeks. Adverse events (AEs) were recorded per NIH Common Terminology Criteria for Adverse Events version 3. Immunogenicity was evaluated by interferon‐gamma ELISpot assay of in vitro sensitized peripheral blood mononuclear cells and lymphocytes from the sentinel immunized node. Eleven participants were enrolled and treated; one was retrospectively found to be ineligible due to HLA type. All 11 participants were included in AEs and survival analyses, and the 10 eligible participants were evaluated for immunogenicity. All participants reported AEs: 82% were Grade 1‐2, most commonly fatigue or injection site reactions. Two participants (18%) experienced treatment‐related dose‐limiting Grade 3 AEs; both were self‐limiting. Immune responses to Her2 or CEA peptides were detected in 70% of participants. Median overall survival (OS) was 16 months; among those enrolled with no evidence of disease (n = 3), median OS was not reached after 10 years of follow‐up. These data demonstrate that vaccination with CEA or Her2 peptides is well tolerated and immunogenic. Further study is warranted to assess potential clinical benefits of vaccination in advanced CRC either alone or in combination with CBT.

News (Medical) associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

26 Nov 2024

·www.globenewswire.com

Greenwich LifeSciences Partners with GIM in Italy

STAFFORD, Texas, Nov. 26, 2024 (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 its partnership with clinical sites in Italy. The Company has partnered with "Gruppo Italiano Mammella" (GIM), the largest academic cooperative breast cancer research group in Italy, including over 150 participating centers and approximately 500 investigators, with 28 clinical trials on-going today. GIM conducts independent research in innovative technologies and overall, more than 16,000 patients have been involved in approximately 30 studies conducted by the group so far. According to the latest data collected by the European Cancer Information System (click here), a total of 58,160 new cases of breast cancer were diagnosed in Italy in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Italy with 15,455 deaths in 2022. Nine of the top enrolling institutions belonging to GIM have agreed to participate in FLAMINGO-01. These sites were approved by Italian authorities, which has led to in-person training and start-up activities with all sites. At the annual national GIM conference in September 2024, updates on the FLAMINGO trial and new research proposals of interest to the entire group were discussed. Professor Grazia Arpino commented, "The FLAMINGO-01 trial is of great interest to me and to my patients. I originally served on the Data Safety Monitory Board of FLAMINGO-01. As I became more familiar with the potential of GLSI-100, I felt that it was important to give the opportunity to patients in Italy to participate in the trial. I therefore presented the FLAMINGO-01 to my colleagues in GIM, and they also enthusiastically agreed to participate. My institution was the first site in Italy to be activated, and we have already started enrollment and treatment of patients." Grazia Arpino, Professor in Oncology and head of the Breast Cancer Group at the University of Naples Federico II is an expert in mechanism of resistance to endocrine therapy and anti-HER2 therapies in breast cancer. Her research mainly focuses on the development of novel medical strategies to overcome mechanisms of resistance to current anticancer therapies, with more than 137 published articles and an h-index of 39. She is the Principal Investigator in several national and international clinical trials, she is a member of the scientific committee of GIM, and she serves as the Italian National Principal Investigator for FLAMINGO-01. Professor Sabino De Placido, head of the GIM group, commented, "In the past, HER2-positive breast cancer had a very bad prognosis. Today, with novel anti-HER2 targeting therapies, the relapse rate in patients with early disease has improved, but there is still room for amelioration, particularly in high-risk patients. The vaccine being tested in the FLAMINGO-01 study offers an excellent, innovative opportunity to reduce these relapses without increasing the side effects of treatment." CEO Snehal Patel commented, "Italy is the first country where we have personally visited and trained all of the sites participating in FLAMINGO-01. These sites are well located near large cities that will provide convenient access to patients. We are truly grateful for the time and commitment from our Italian colleagues." “The team of trial sites, clinical investigators, and support personnel in Italy has exceeded our expectations, and we are encouraged that FLAMINGO-01 is off to an excellent start in Italy,” added Jaye Thompson, VP of Clinical and Regulatory Affairs. Some of the most important Italian breast cancer units are participating in the trial: NCI Pascale of Naples with Professor Michelino De Laurentiis, San Martino Hospital in Genova with Professor Lucia Del Mastro, Maggiore Hospital in Novara with Professor Alessandra Gennari, IOV in Padova with Professor Valentina Guarneri, Saint Orsola Hospital in Bologna with Professor Claudio Zamagni, Humanitas Cancer Centre in Rozzano (MI) with Professor Alberto Zambelli, Maugeri Institute in Pavia with Professor Laura Locati, and Gemelli Foundation with Professor Alessandra Fabi. The full list of participating centers is shown below and listed on clinicaltrials.gov here, where an interactive map can be used by patients to locate a hospital to contact regarding potential participation in the clinical trial. Bologna Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Genova Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Milan Humanitas Research Hospital Naples (2) Azienda Ospedaliera Universitaria Federico II Di NapoliIstituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Novara Azienda Ospedaliero Universitaria Maggiore della Carità di Novara Padova Istituto Oncologico Veneto Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Rome Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) About FLAMINGO-01 and 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. 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. 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 www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. 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 Form 10-K for the year ended December 31, 2023 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 ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 3ImmunotherapyVaccine

18 Nov 2024

·www.globenewswire.com

Greenwich LifeSciences Provides Update on Corporate Events

STAFFORD, Texas, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on corporate events. The Company's 2024 events to date are listed below: Feb 29 - Mar 1, 2024 – GBG Annual Scientific Meeting (German clinical network conference)Jun 1 - 4, 2024 – American Society of Clinical Oncology (ASCO) Annual MeetingJun 3 - 6, 2024 – BIO International Convention (partnering conference)Jun 4 - 6, 2024 – Jefferies Global Healthcare ConferenceSep 9 - 10, 2024 – H.C. Wainwright 26th Annual Global Investment ConferenceOct 5, 2024 – Komen Houston Race for the Cure (sponsor)Nov 4 - 6, 2024 – 30th Annual BIO-Europe Fall 2024 (partnering conference)Nov 7, 2024 – 13th Annual Texas Life Science Forum (guest speaker) The Company's planned upcoming events are listed below: Nov 19 - 21, 2024 – Jefferies London Healthcare ConferenceDec 10 - 13, 2024 – San Antonio Breast Cancer Symposium (SABCS)Dec 19, 2024 – Annual Meeting of StockholdersFeb 10 - 11, 2025 – BIO CEO & Investor ConferenceMar 6 - 7, 2025 – GBG Annual Scientific Meeting About FLAMINGO-01 and 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. 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. 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 www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. 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 Form 10-K for the year ended December 31, 2023 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 ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 3ImmunotherapyASCO

01 Aug 2024

·www.globenewswire.com

Greenwich LifeSciences Provides Update on Expansion of Flamingo-01 into Spain

STAFFORD, Texas, Aug. 01, 2024 (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 of the expansion of clinical sites into Spain. As previously announced, the Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01. To date, approximately 30 out of 38 sites have conducted site initiation visits (SIVs). An SIV is followed by site activation, HLA type screening, and study treatment. To date approximately 19 sites have been activated. Multiples sites have begun screening patients for HLA type and have started treating patients. The Company has visited and trained in-person at approximately 26 out of the 38 sites to ensure optimal treatment at each site. In the coming months, GEICAM hopes to complete the remaining SIVs and the Company hopes to visit the remaining sites. "It has been an honor to meet with the excellent study staff, investigators and GEICAM staff across Spain. Their expertise and interest in FLAMINGO-01 is encouraging for the success of the study. We look forward to seeing patient recruitment increase in Spain as other countries in the European Union become active," remarked Jaye Thompson, VP of Clinical and Regulatory Affairs. CEO Snehal Patel commented, "The remarkable progress in Spain, in just May through July, is a testament to the commitment of GEICAM and our team to collaborate and to train the sites together, which we hope will lead to high quality treatment of patients. With just these 30 sites, we have approximately doubled the number of sites that we have opened in the US." The Company may provide updates on the status of other countries in Europe as the clinical trial is expanded to up to 150 sites in the US, Spain, Italy, France, Germany, and Poland. About GEICAM Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain. It has conducted more than 140 studies involving more than 67,000 women and men and is comprised of more than 900 experts based in over 200 Spanish hospitals. Its mission is to promote independent clinical, epidemiological, and translational research in oncology, with a multidisciplinary approach and under quality criteria, to improve health outcomes, as well as prevention, medical education, and the dissemination of the knowledge of this disease to patients and general society. More information on GEICAM can be found at https://www.geicam.org/. About FLAMINGO-01 and 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. 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. 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 www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. 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 Form 10-K for the year ended December 31, 2023 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 ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 3Immunotherapy

100 Deals associated with HER2/Neu GP2 vaccine (Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 3	US	Greenwich LifeSciences, Inc.	11 Aug 2022
HER2 Positive Breast Cancer	Phase 3	FR	Greenwich LifeSciences, Inc.	11 Aug 2022
HER2 Positive Breast Cancer	Phase 3	DE	Greenwich LifeSciences, Inc.	11 Aug 2022
HER2 Positive Breast Cancer	Phase 3	IT	Greenwich LifeSciences, Inc.	11 Aug 2022
HER2 Positive Breast Cancer	Phase 3	PL	Greenwich LifeSciences, Inc.	11 Aug 2022
HER2 Positive Breast Cancer	Phase 3	ES	Greenwich LifeSciences, Inc.	11 Aug 2022
Breast Cancer	Phase 2	US	NuGenerex Immuno-Oncology, Inc.	01 Jan 2007
Breast Cancer	Phase 2	DE	NuGenerex Immuno-Oncology, Inc.	01 Jan 2007
Breast Cancer	Phase 2	GR	NuGenerex Immuno-Oncology, Inc.	01 Jan 2007
Breast Cancer	Phase 2	GR	Greenwich LifeSciences, Inc.	01 Jan 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00524277 (ASCO2022) Manual	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2 Positive	180	GLSI-100	fsfzgzvbxr(btafhilmrc) = bxytxvdhdh gmnrnxnafq (alzbogmcse )	Positive	02 Jun 2022
				GM-CSF	fsfzgzvbxr(btafhilmrc) = iszxcvsapt gmnrnxnafq (alzbogmcse )
NCT05232916 (Corporate Publications) Manual	Phase 2	Metastatic breast cancer HER2 positive \| HER3 positive	180	GLSI-100	uinfqigyke(fpjiuzltqr) = ooxmufztqe bwcthndumq (kvvabedqrq )	Positive	19 Apr 2022
				GM-CSF	uinfqigyke(fpjiuzltqr) = bipbyupckb bwcthndumq (kvvabedqrq )
NCT00524277 (AACR2021) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	180	GM-CSF+GP2	zinnbzguww(rjfyqdjwng) = ixbcseeddr vaabnmtfau (vkzagryuxy, 59.5 - 87.9) View more	Positive	15 Feb 2021
				GM-CSF	zinnbzguww(rjfyqdjwng) = yrtxcdmtif vaabnmtfau (vkzagryuxy, 60.1 - 88.2) View more
NCT00524277 (GP2, SABCS2021)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2 positive	180	GP2+GM-CSF	nngmvnxpev(rocycrpcur) = mhcrcjxssl efwpwvdxin (awmuyorvrz )	Positive	15 Feb 2021
				GM-CSF	nngmvnxpev(rocycrpcur) = nrdtarilyd efwpwvdxin (awmuyorvrz, 76.2 - 95.5)

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