Greenwich LifeSciences, Inc.
Clinical-stage biopharmaceutical company developing a peptide-based cancer immunotherapy combining a HER2/neu-derived peptide with an immunoadjuvant. Conducting a Fast Track designated Phase III randomized, double-blind multicenter trial (Flamingo-01) across ~150 sites to evaluate prevention of breast cancer recurrence in HER2-positive patients; prior clinical program includes three Phase I trials and one Phase IIb trial with 146 treated patients.
Industries
Nr. of Employees
small (1-50)
Greenwich LifeSciences, Inc.
Products
Peptide-based cancer immunotherapy (peptide + immunoadjuvant)
A short HER2/neu-derived peptide antigen administered intradermally with an immunoadjuvant to stimulate antigen-presenting cells and elicit CD8+ cytotoxic T cell responses against HER2-expressing tumor cells.
Peptide-based cancer immunotherapy (peptide + immunoadjuvant)
A short HER2/neu-derived peptide antigen administered intradermally with an immunoadjuvant to stimulate antigen-presenting cells and elicit CD8+ cytotoxic T cell responses against HER2-expressing tumor cells.
Expertise Areas
- Clinical trial management
- Peptide immunotherapy development
- Immuno-oncology and immune monitoring
- Clinical data management and biostatistics
Key Technologies
- Peptide-based vaccine immunotherapy
- Immunoadjuvant co-administration (GM-CSF)
- Dimer binding assays for antigen-specific CTLs
- Delayed-type hypersensitivity (DTH) skin testing
News & Updates
Initiation and ongoing enrollment of a Fast Track designated Phase III randomized, double-blind multicenter trial (Flamingo-01) to evaluate the peptide immunotherapy for prevention of breast cancer recurrence.
Corporate presentation, analyst reports, and media interviews listed by the company (examples include corporate presentation PDF and analyst conference participation).
Phase IIb prospective randomized trial (16 sites led by MD Anderson) reported an 80% or greater reduction in metastatic breast cancer recurrence rate in the treated HER2 3+ cohort after 5 years of follow-up; immune responses peaked at ~6 months and safety profile showed no serious adverse events attributable to treatment across 146 treated patients in four trials.
Multiple conference posters and publications reporting immune response (dimer assay and DTH) and safety data across multi-year follow-up from Phase IIb and earlier trials.
Initiation and ongoing enrollment of a Fast Track designated Phase III randomized, double-blind multicenter trial (Flamingo-01) to evaluate the peptide immunotherapy for prevention of breast cancer recurrence.
Corporate presentation, analyst reports, and media interviews listed by the company (examples include corporate presentation PDF and analyst conference participation).
Phase IIb prospective randomized trial (16 sites led by MD Anderson) reported an 80% or greater reduction in metastatic breast cancer recurrence rate in the treated HER2 3+ cohort after 5 years of follow-up; immune responses peaked at ~6 months and safety profile showed no serious adverse events attributable to treatment across 146 treated patients in four trials.
Multiple conference posters and publications reporting immune response (dimer assay and DTH) and safety data across multi-year follow-up from Phase IIb and earlier trials.