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DRUG:

GLSI-100

i
Other names: GLSI-100, GP2 peptide/GM-CSF vaccine
Associations
Company:
Greenwich LifeSci
Drug class:
Immunostimulant
Related drugs:
Associations
1year
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (SABCS 2023)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. Contact Information: Greenwich LifeSciences, Inc. Stafford, TX Email: Flamingo-01@greenwichlifesciences.com Website: greenwichlifesciences.com
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
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HER-2 expression • HLA-A*02 • HLA-A2 positive
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Herceptin (trastuzumab) • GLSI-100
over1year
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (ESMO 2023)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study has been initiated in the US with plans to open in Europe.
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
HER-2 expression • HLA-A*02 • HLA-A2 positive
|
Herceptin (trastuzumab) • GLSI-100
over1year
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neoadjuvant and postoperative adjuvant anti-HER2 therapy: Flamingo-01. (ASCO 2023)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. The study is also expected to be opened in Spain, Germany, and France. Clinical trial information: NCT05232916.
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
HER-2 expression • HLA-A*02 • HLA-A2 positive
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Herceptin (trastuzumab) • GLSI-100
over1year
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (ESMO-BC 2023)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study has been initiated in the US with plans to open in Europe.
Clinical • P3 data
|
HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
HER-2 expression • HLA-A*02 • HLA-A2 positive
|
Herceptin (trastuzumab) • GLSI-100
over1year
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (AACR 2023)
Funding: This trial is supported by Greenwich LifeSciences. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm.Eligibility Criteria: The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA-A*02; 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy; 3) Exclude Stage IV; and 4) Completed at least 90% of planned trastuzumab-based therapy.Trial Objectives: 1) To determine if GP2 therapy increases IBCFS; 2) To assess the safety profile of GP2; and 3) To monitor immunologic responses to treatment and assess relationship to efficacy and safety.Study Status: The study has been initiated at a number of sites in the US. The study is also expected to be opened in Spain, Germany, and France.
Clinical • P3 data
|
HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
HER-2 expression • HLA-A*02 • HLA-A2 positive
|
Herceptin (trastuzumab) • GLSI-100
2years
Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (SABCS 2022)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. To assess the safety profile of GP2 3. To monitor immunologic responses to treatment and assess relationship to efficacy and safety
Clinical • P3 data
|
HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
HER-2 expression • HLA-A*02 • HLA-A2 positive
|
Herceptin (trastuzumab) • GLSI-100
2years
Analysis of T-cell receptor sequences in a phase 3 study of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (SABCS 2022)
After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. T-cells that were present at baseline potentially represent the existing immune state and may contain some GP2 specific T- cells, which will be confirmed with future singe cell sequencing experiments that identify T-cells specific to GP2 and other antigens. T-cells that expanded after treatment with GLSI-100 are potentially GP2 specific T-cells and may be mechanistically relevant. These findings support further study of the use of TCR sequencing to assess immune response to GLSI-100 vaccination.]
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
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HER-2 expression
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Herceptin (trastuzumab) • GLSI-100
over2years
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02 • HLA-A2 positive
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Herceptin (trastuzumab) • GLSI-100
over2years
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.
Clinical • P2b data
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HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
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HER-2 positive • HER-2 expression
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Herceptin (trastuzumab) • GLSI-100 • GP2 • Leukine (sargramostim)
over2years
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 • P2b data • Late-breaking abstract
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HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
|
HER-2 positive • HER-2 expression
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Herceptin (trastuzumab) • GLSI-100 • GP2 • Leukine (sargramostim)
over2years
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, Flamingo-01 (AACR 2022)
The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up for a total of 4 years following the first year of treatment with trastuzumab-based therapy. Patients will be stratified based on residual disease status at surgery, hormone receptor status, prior pertuzumab therapy and region...Target enrollment is 598 subjects.Contact information: Snehal Patel Greenwich LifeSciences, Inc. Stafford, TX Email: snehal.patel@greenwichlifesciences.com Website: greenwichlifesciences.com
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
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HER-2 expression • HLA-A*02 • HLA-A2 positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • GLSI-100
over2years
Clinical • P2b data
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HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
|
HER-2 positive
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Herceptin (trastuzumab) • GLSI-100 • GP2
over2years
Clinical • P2b data
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HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
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HER-2 positive
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Herceptin (trastuzumab) • GLSI-100 • GP2
over2years
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, 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
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02 • HLA-A2 positive
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Herceptin (trastuzumab) • GLSI-100
almost3years
New P3 trial
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02 • HLA-A2 positive
|
Herceptin (trastuzumab) • GLSI-100
3years
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: greenwichlifesciences.com Funding : This trial is supported by Greenwich LifeSciences.
Clinical • P3 data
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HER-2 (Human epidermal growth factor receptor 2) • HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
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HER-2 expression • HLA-A2 positive
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GLSI-100 • GP2 • Leukine (sargramostim)