Greenwich LifeSciences is focused on developing GP2, an innovative immunotherapy aimed at preventing breast cancer recurrences in patients who have undergone surgery. This therapy is derived from the HER2/neu protein, which is commonly expressed in breast cancer and other malignancies. The company is currently conducting the Flamingo-01 Phase III clinical trial, which aims to assess the safety and efficacy of GP2 in HER2/neu positive patients with residual disease or high-risk pathologic complete response after receiving trastuzumab-based treatment. The trial is set to expand globally, with plans to open up to 150 sites, reflecting the company's commitment to advancing cancer treatment through rigorous clinical research.

The GP2 immunotherapy has shown promising results in previous studies, particularly in a Phase IIb trial where it demonstrated a significant reduction in cancer recurrences among treated patients. The therapy involves a Primary Immunization Series (PIS) of intradermal injections, which elicits a robust immune response, as evidenced by various immunological assays. Additionally, booster injections are administered every six months to prolong the immune response, contributing to long-term protection. The safety profile of GP2 has been favorable, with no serious adverse events reported, indicating its potential as a well-tolerated treatment option for patients at high risk of breast cancer recurrence.

United States

Greenwich Life Sciences is a biopharmaceutical company that focuses on developing an immunotherapy, GP2, to prevent breast cancer recurrences in post-surgery patients.

Cancer

Immune System Diseases

Greenwich LifeSciences

Breast cancer

GP2 is a nine amino acid transmembrane peptide of the HER2/neu protein. &nbsp;HER2/neu is a cell surface receptor protein that is expressed in 75% of breast &nbsp;cancer in addition to a variety of other common cancers.&nbsp; Following GP2 &nbsp;immunotherapy, CD8+ cytotoxic T lymphocytes (“CTLs”) recognize and &nbsp;destroy HER2/neu-expressing cancer cells.&nbsp; GP2 is administered &nbsp;in combination with GM-CSF, an FDA-approved immunoadjuvant, which &nbsp;stimulates the proliferation of antigen presenting cells.
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Greenwich LifeSciences

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