Greenwich LifeSciences Inc

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) is a public biopharmaceutical company based in the Houston, TX area that is developing GP2, a novel peptide immunotherapy, and has commenced a Phase III clinical trial.

GP2 is derived from the HER2/neu protein, which is expressed in a variety of common cancers, including breast cancer. Tumors with elevated expression of HER2/neu protein are highly aggressive, resulting in an increased disease recurrence and a worse prognosis. In a Phase IIb clinical trial in the HER2/neu 3+ adjuvant setting, no breast cancer recurrences were observed after median 5 years of follow-up if the patient was fully immunized. In addition, GP2 treatment is well tolerated and no serious adverse events related to GP2 immunotherapy were reported.

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