GP2 / Generex, Greenwich LifeSci - LARVOL DELTA

Baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer. (ASCO 2022) - "Background: Delayed type hypersensitivity (DTH) skin tests to GP2 were conducted in the randomized, active-controlled, single-blinded, multicenter Phase IIb trial investigating GLSI-100 (GP2+GM-CSF) administered in the adjuvant setting to node-positive and high-risk node-negative breast cancer patients with tumors expressing HER2. Baseline GP2 immune response as measured by the delayed-type hypersensitivity test may be an independent prognostic factor for recurrence. Knowledge of this GP2 immune response may identify a patient with increased risk of rapid recurrence."

Biomarker • Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Immunology • Oncology • Solid Tumor • CSF2 • HER-2

GP2 immune response a predictor of recurrence in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with breast cancer (AACR 2022) - "The authors did not submit an updated abstract. The original abstract should be considered final."

Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2

Injection site reactions correlate to delayed type hypersensitivity tests and suggest that GP2 reverses immune suppression of trastuzumab-treated HER2 positive patients in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) vs. GM-CSF after adjuvant trastuzumab in HER2 positive women with breast cancer (AACR 2022) - "The authors did not submit an updated abstract. The original abstract should be considered final."

Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2

Evaluation of booster injections in maintaining peak immunity in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus GM-CSF alone after adjuvant trastuzumab in women with HER2-positive breast cancer. (ASCO 2022) - "Background: Injection site reactions (ISR) of booster injections in the randomized, active-controlled, single-blinded, multicenter Phase IIb trial of GLSI-100 (GP2+GM-CSF) administered in the adjuvant setting to node-positive and high-risk node-negative breast cancer patients with tumors expressing HER2 have been analyzed. Administering GLSI-100 boosters at 6 month intervals to patients produced a consistent nadir ISR approximately 20 mm lower than the maximum PIS ISR of 92.1 mm which is still larger than the maximum ISR in GM-CSF only patients of 60.5 mm. A patient’s immune response a month after booster dosing would theoretically be the peak ISR, which will be measured in future trials by measuring T-cell response and DTH one month after booster injections, further helping to evaluate booster strategies to sustain peak immunity over longer periods of time."

Clinical • Late-breaking abstract • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • CSF2 • HER-2

Analysis of GP2 immune response and relationship to recurrence in a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 (GLSI-100) vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer (SABCS 2021) - P2 | "Background : Delayed type hypersensitivity (DTH) skin tests in the randomized, active-controlled, single-blinded, multicenter Phase IIb trial investigating GLSI-100 (GP2+GM-CSF) administered in the adjuvant setting to node-positive and high-risk node-negative breast cancer patients with tumors expressing any degree of HER2 (immuno-histochemistry [IHC] 1-3+) ( NCT00524277 ) have been analyzed. It is theorized that a positive baseline DTH skin test to GP2 may be evidence of an existing immune response to GP2 associated with residual disease, impending recurrence, or prior treatments. Further studies assessing if GP2 immune response is an important prognosticator of cancer disease state or recurrence are planned."

Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Provides Updates on Upcoming Phase III Clinical Trial, Patent Filings, & AACR Meeting (Businesswire) - "The listing of the Flamingo-01 Phase III trial on clinicaltrials.gov provides clinicians and patients with an important source of information including trial updates and design, participating clinical sites, and contact information...Three abstracts/posters were accepted for presentation at the upcoming AACR Annual Meeting 2022. The AACR plans to publish the 3 abstracts on April 8, 2022 and the 3 posters on April 11-12, 2022....The Company anticipates making various patent filings that cover clinical use of GLSI-100, use of immune response data to improve patient treatment, manufacturing of GP2, and the administration and preparation of GLSI-100. If these patent claims are issued, they have the potential to extend the patent life of GP2 beyond 2040."

Clinical • Clinical data • Patent • Breast Cancer • Oncology • Solid Tumor

FLAMINGO-01: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (clinicaltrials.gov) - P3 | N=598 | Not yet recruiting | Sponsor: Greenwich LifeSciences, Inc. | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • HLA-A

Greenwich LifeSciences CEO Participates in TD Ameritrade Interview to Discuss 2021 SABCS Poster (Businesswire) - "Greenwich LifeSciences, Inc...announced that CEO Snehal Patel participated in a TD Ameritrade interview to discuss the Phase IIb poster presented at the 2021 San Antonio Breast Cancer Symposium on December 9, 2021...In the interview, Mr. Patel discussed how the new Phase IIb clinical trial findings could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect metastatic breast cancer recurrences earlier...The number of recurrences was low in the Phase IIb clinical trial, so these observations will be confirmed further in the larger Phase III trial, and the data will be available as early as 2022."

Clinical • P2 data • Breast Cancer • Oncology

A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy (SABCS 2021) - "Background : GP2 is a biologic nine amino acid peptide of the HER2/ neu protein delivered in combination with an FDA-approved immunoadjuvant Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, Sargramostim, Leukine) that stimulates an immune response targeting HER2/neu expressing cancers. This sample size provides 80% power if the annual rate of events in placebo-treated patients is 2.4% or greater. Eligibility Criteria : The patient population is defined by these key eligibility criteria: HER2/neu positive and HLA-A*02 Residual disease or High risk pCR (Stage III at presentation) post appropriate neo-adjuvant therapy Exclude Stage IV Completed at least 75% of planned trastuzumab-based therapy Trial Objectives : To determine if GP2 therapy increases invasive disease-free survival (IDFS) To assess the safety profile of GP2 To monitor immunologic responses to treatment and assess relationship to efficacy and safety Contact information : Website:..."

Clinical • P3 data • Residual disease • Breast Cancer • Oncology • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Announces Presentation of 5 Year Data for GP2 Phase IIb Clinical Trial, Revealing Potential For New T Cell Platform Technology (Businesswire) - P2b, N=456; NCT00524277; "Greenwich LifeSciences, Inc...announced the publication of a poster for the GP2 Phase IIb clinical trial at the San Antonio Breast Cancer Symposium 2021 (SABCS)...It was observed that 22.8% or 33 patients of the 145 patients reacted to GP2 at baseline with a positive immune response, which is defined as an induration of 5 mm or greater in the baseline DTH test...'We expect new T cell data from the Phase III trial to become available in 2022'...After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 46 HER2 3+ patients treated with GLSI-100, if the patient completed the PIS, was 100% versus 89.4% (95% CI:76.2, 95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338)."

P2b data • P3 data • Breast Cancer • HER2 Positive Breast Cancer • Oncology

Greenwich LifeSciences Announces Acceptance of Two Posters at Upcoming 2021 SABCS Breast Cancer Conference (Businesswire) - "Greenwich LifeSciences, Inc...announced that two abstracts and posters have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS)...The second abstract and poster will present additional features of the Phase III clinical trial providing information to breast cancer clinicians who will be attending the in-person conference, visiting our poster session, and participating in our first Phase III trial investigator meeting where the global primary investigator and the Company will present the trial to participating clinicians."

Clinical data • Breast Cancer • Oncology

Greenwich LifeSciences to Participate in Jefferies’ 12th Annual London Healthcare Conference (Businesswire) - "Greenwich LifeSciences, Inc...focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced CEO Snehal Patel will participate in the virtual portion of Jefferies’ Annual London Healthcare Conference held from November 16-19, 2021....The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required."

Clinical • Clinical protocol • Breast Cancer • Oncology • Solid Tumor

Greenwich LifeSciences Provides Updated Corporate Presentation and Webcasts (Businesswire) - "We have been discussing possible licensing of GP2, new investment banking partners, collaboration in our Phase III clinical trial, commercial manufacturing, expansion of our pipeline, expansion of our clinical trials in Europe, and initiation of additional GP2 Phase II/III trials.'"

Licensing / partnership • New P2/3 trial • Breast Cancer • Oncology

[VIRTUAL] Final five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating a time series of immune responses using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer (AACR 2021) - P2 | "Immunological data comparing peak immunity to baseline and GP2 treated patients to placebo showed that GP2 treated patients, independent of HER2 status, experienced a significant increase in their immune response while those receiving GM-CSF only did not. Future studies may explore the use of immune responses to assess: immunogenicity of GP2 by HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders."

Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD8 • CSF2 • HER-2

[VIRTUAL] Final five-year median follow-up safety data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the use of HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer. (ASCO 2021) - P2 | "Clinical Trial Registry Number: NCT00524277 Funding: Greenwich LifeSciences . The study confirms the finding from the Phase I trial evaluating GP2+GM-CSF that the vaccine is safe and well-tolerated . The majority of patients experienced only mild local and systemic toxicities . Importantly, toxicities in the GP2+GM-CSF group were comparable to those seen in the GM-CSF only group, suggesting the toxicities are attributable to GM-CSF."

Clinical • P2b data • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Musculoskeletal Pain • Oncology • Pain • Pruritus • Solid Tumor • CSF2 • HER-2

[VIRTUAL] Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer (SABCS 2020) - P2 | "A pivotal Phase III trial is being initiated to treat HER2 3+ patients in the neoadjuvant setting. GP2 also may be effective when used in parallel to trastuzumab based therapeutics or in combination with trastuzumab based therapeutics in HER2 1-2+ or other HER2 expressing cancers."

Clinical • P2b data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2

Greenwich LifeSciences Publishes Additional Positive Safety Data from GP2 Phase IIb Trial at ASCO 2021, Confirming that GP2 Treatment to Prevent Metastatic Breast Cancer Recurrence is Well Tolerated (Businesswire) - P2, N=456; NCT00524277; "Greenwich LifeSciences...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, presented an abstract and poster of the final 5 year GP2 Phase IIb clinical trial safety data at the 2021 ASCO Annual Meeting....GP2 immunotherapy is well-tolerated and no safety signal for GP2 was identified. Additionally, no serious adverse events related to GP2 immunotherapy were reported over the full 5 year treatment and follow-up periods."

P2 data • Breast Cancer • Oncology

[VIRTUAL] A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. (ASCO 2021) - "Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with an FDA-approved immunoadjuvant Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, sargramostim, leukine) that stimulates an immune response targeting HER2/neu expressing cancers . To monitor for any unexpected adverse events and toxicities related to GP2 therapy . Accrual: The target enrollment is up to approximately 500 patients."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • CSF2 • HER-2

[VIRTUAL] Greenwich LifeSciences (BIO 2021) - "In a completed Phase IIb study, no recurrences have been observed in the Her2/neu 3+ adjuvant setting after median 5 years follow-up, if the patient received the 6 primary intradermal injections over the first 6 months. 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 75% of breast cancers."

Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

[VIRTUAL] A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer (AACR 2021) - "Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with an FDA-approved immunoadjuvant Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, Sargramostim, Leukine) that stimulates an immune response targeting HER2/neu expressing cancers. The participant duration of the trial will be 3 years treatment plus 2 years follow-up for a total of 5 years following the first year treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.Eligibility Criteria: The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year treatment with trastuzumab-based therapy.Trial Objectives:To determine if GP2 therapy reduces recurrence in HER2/neu positive breast cancer patients.To..."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2

Greenwich LifeSciences Announces Update of GP2 Phase III Clinical Trial Design at the 2021 AACR Annual Meeting (Businesswire) - “The GP2 Phase III clinical trial design was presented in a poster during the 2021 American Association for Cancer Research (AACR) Annual Meeting…The Company plans to complete manufacturing of GP2 by the end of the 3rd quarter 2021 and plans to commence the Phase III clinical trial thereafter. A third open-label arm has been added to the Phase III trial to test GP2 in HLA types other than HLA-A02 and to assess immune response and clinical outcome…The Phase III trial design will include an event-driven interim analysis for superiority or futility. This analysis will be conducted when approximately half of the expected breast cancer recurrences have occurred, which may allow for submission of a Biologics Licensing Application (BLA) to the FDA for conditional marketing approval of GP2 approximately halfway through the trial.”

Clinical protocol • New P3 trial • Breast Cancer • Oncology

Greenwich LifeSciences Presents Immune Response Phase IIb Poster, Published Today at AACR 2021, Showing Peak Immunity after 6 Months of GP2 Treatment, Resulting in 100% Disease Free Survival from Recurring Breast Cancer (Businesswire) - P2, N=456; NCT00524277; "Poster published today at the 2021 American Association for Cancer Research (AACR) Annual Meeting shows the GP2 final 5 year immune response data from the Phase IIb clinical trial, concluding that GP2 immunotherapy generated GP2-specific immune responses leading to promising clinical benefit, thus supporting GP2’s mechanism of action...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 100% disease free survival (0% recurrence rate) over 5 years."

P2 data • Breast Cancer • Oncology

Greenwich LifeSciences Reports Robust Immune Response Phase IIb Data Supporting GP2 Clinical Outcome of 0% Metastatic Breast Cancer Recurrences Over 5 Years of Follow-up (Businesswire) - P2, N=456; NCT00524277; “Statistically significant peak immunity was reached after 6 months of GP2 treatment as measured in both a GP2 specific CD8 T cell dimer binding assay and a delayed-type-hypersensitivity (DTH) skin test. HER2 3+ population immune response was similar to the HER2 1-2+ population immune response, suggesting the potential to treat the HER2 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents. Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat other HER2 1-3+ expressing cancers. Greenwich LifeSciences…announced the abstract results of the final 5 year immune response data of the Phase IIb clinical trial at the 2021 AACR Annual Meeting.”

P2b data • Breast Cancer • Oncology

Greenwich LifeSciences Updates 2021 Timeline & Announces Two Upcoming Presentations at the American Association for Cancer Research Annual Meeting (Businesswire) - “Final 5 Year Safety Data…Company plans to present the Phase IIb clinical trial final 5 year safety data. To date, the Company has administered GP2 immunotherapy to 138 patients in four clinical trials, where no serious adverse events and a well tolerated safety profile have been reported. Updated Phase III Clinical Trial Design…The Company and the Baylor College of Medicine will present the updated design of the planned Phase III clinical trial. The clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by the submission of a Biologics Licensing Application (BLA).”

P2b data • Trial status • Breast Cancer • Oncology

Greenwich LifeSciences Updates 2021 Timeline & Announces Two Upcoming Presentations at the American Association for Cancer Research Annual Meeting (Businesswire) - “Greenwich LifeSciences…announced the titles and authors of the two abstracts/posters that were accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held in a virtual format from April 10-15, 2021…completion of GP2 manufacturing is planned for 2nd/3rd quarter of 2021…Enrollment of the first patients in the Phase III clinical trial could commence in the 3rd/4th quarter of 2021…Final 5 Year Immune Response Data…The presentation will include analysis of delayed type hypersensitivity skin tests and immunological assays used to measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, such as a comparison of peak immune response versus baseline immune response at multiple time points.”

Commercial • Enrollment status • P3 data • Breast Cancer • Oncology