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

NCT00524277 / CompletedPhase 2

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.

Start Date01 Jan 2007

Sponsor / Collaborator

San Antonio Military Medical Center

[+2]

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 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.

03 Jul 2020·Immunopharmacology and immunotoxicologyQ4 · MEDICINE

Investigation of the combination of anti-PD-L1 mAb with HER2/neu-loaded dendritic cells and QS-21 saponin adjuvant: effect against HER2 positive breast cancer in mice

Q4 · MEDICINE

Article

Author: Karaboz, İsmail ; Özverel, Cenk Serhan ; Nalbantsoy, Ayse ; Uyanikgil, Yiğit

BACKGROUND:

Human epidermal growth factor receptor 2 (HER2) is overexpressed in a subset of cancers including 25% of breast cancers. Since combination therapy consisting of multiple therapeutic approaches is considered a promising regimen, we examined combination treatment modalities in a xenograft model in Balb/c mice injected with 4T1-HER2 cells. We used HER2/neu-loaded bone marrow-derived dendritic cells (BM-DC's) along with anti-PD-L1 monoclonal antibody in a new combination immunotherapy model.

METHODS:

The combination was composed of an active immunotherapy (i.e. BM-DC-based vaccine) designed to boost the immune response against target antigen and was augmented by using anti-PD-L1 mAb to prevent immune evasion by the xenografted tumors. The vaccine combination was further supported using a QS-21 saponin adjuvant and the immune response was evaluated.

RESULTS:

Mice treated with HER2/neu-loaded BM-DCs, combined with QS-21 and anti-PD-L1 mAb had significantly decreased tumor sizes and their splenocytes had enhanced cytotoxic activity, based on the lactate dehydrogenase (LDH) assay, compared to vaccine and adjuvant groups alone. The same vaccination group demonstrated a remarkable increase in IFN-γ secreting CD8+ T-cells analyzed by flow cytometry. ELISA data also revealed a significant increase in the serum anti-HER2 IgG1 response; in addition, there was significant splenocyte proliferation upon stimulation with antigen compared to vaccine and adjuvant groups. Consistently, a significant infiltration of CD4+, CD8+ immune cells in and around the tumors was observed.

CONCLUSIONS:

Our data suggest that the BM-DC + HER2/neu + QS-21 + anti-PD-L1 vaccine combination paradigm synergistically generates anti-tumor activity and immune responses against HER2 overexpressing breast cancer in mice.

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

14 Jun 2024

·www.biospace.com

Greenwich LifeSciences Announces $2.5 Million Private Placement

STAFFORD, Texas, June 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company" or "Greenwich"), 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 that it has entered into a securities purchase agreement with its Chief Executive Officer, Snehal Patel, for the purchase and sale of 174,825 shares of its common stock at a purchase price of $14.30 per share in a private placement. The closing of the private placement is expected to occur on or about June 18, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $2.5 million, before deducting offering expenses payable by the Company. Greenwich intends to use the net proceeds from the offering for clinical development and working capital. No investment banking fees are being paid in connection with this offering. Mr. Patel has agreed to a one year lock up agreement with respect to his shares of common stock acquired in the offering. The offer and sale of the foregoing shares were made by Greenwich in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 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 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

Phase 3Immunotherapy

13 Mar 2024

·www.biospace.com

Greenwich LifeSciences Extends Lock-up of Directors and Officers to June 30, 2025

STAFFORD, Texas, March 13, 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 that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to June 30, 2025 which is approximately 57 months from date of the Company's IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors. 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/neu 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 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (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/neu 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 Form 10-K for the year ended December 31, 2022 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

ImmunotherapyPhase 3

27 Feb 2024

·www.biospace.com

Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries

STAFFORD, Texas, Feb. 27, 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 provided the following update on the expansion of the clinical trial into Europe. The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this final approval, regulators have cleared the way to activate 105 sites as soon as site contracts and site initiation visits are completed. Site initiation visits have been scheduled as early as the week of March 4, 2024. CEO Snehal Patel commented, "We have been planning this expansion for over 2 years and are thrilled to be making GLSI-100 available to patients in Europe in these major countries with a total population of approximately 300 million. The interest in developing a vaccine to prevent the recurrence of breast cancer is very high in the European clinical and academic community, especially given the promising efficacy and safety pro the prior GLSI-100 trials. We look forward to working very closely with our European colleagues and will start by training site staff, pharmacists, and nurses. We hope to open sites as quickly as possible, while applying to open additional sites in the approved countries and potentially adding additional countries in Europe." 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/neu 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 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (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/neu 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 Form 10-K for the year ended December 31, 2022 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

Phase 3ImmunotherapyVaccine

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

R&D Status

10 top R&D records.

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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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05232916 (Corporate Publications) Manual	Phase 2	Metastatic breast cancer HER2 positive \| HER3 positive	180	GLSI-100	empmghveoq(txdvkzsuve) = rroylddcyb zngcoeiccl (sqnozixkce )	Positive	19 Apr 2022
				GM-CSF	empmghveoq(txdvkzsuve) = kwryxmglvd zngcoeiccl (sqnozixkce )
NCT00524277 (AACR2021) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	180	GM-CSF+GP2	mbvfdtglbs(fgscytnvmu) = uphebvfunx kprsaehdil (qiwjrtehbi, 59.5 - 87.9) View more	Positive	15 Feb 2021
				GM-CSF	mbvfdtglbs(fgscytnvmu) = vnxnnjvxdd kprsaehdil (qiwjrtehbi, 60.1 - 88.2) View more

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