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February 11 - 12, 2019 | New York, New York
Greenwich LifeSciences (GLS) is a private biopharmaceutical company located in Houston, TX that is developing GP2, a novel peptide immunotherapy, planning to commence a Phase III trial in 2019, pending funding. In a just completed Phase IIb study, no recurrences have been observed in the Her2/neu 3+ adjuvant setting for up to 5 years if the patient is fully vaccinated. 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.
Upcoming Phase III Clinical Trial – FDA has approved the Phase III trial protocol and manufacturing has commenced.
Substantial Unmet Need – Following breast cancer surgery, a Her2/neu 3+ patient receives Herceptin in the first year and then hopes that their breast cancer will not recur, with the odds of recurrence slowly decreasing over the first 5 years. Herceptin reduces recurrence rates from 25% to 12%, leaving us with the unmet need and potential to use GP2 to fully address the 50% of recurring patients who do not respond to Herceptin.
Compelling Clinical Phase IIb Data – In a just completed randomized single-blinded multi-centered (15 sites) Phase IIb clinical trial of 180 HLA-A02 patients of which 101 patients are Her2/neu (3+) over expressor patients, GP2 displayed outstanding efficacy. At up to 5 years of follow up, there were 0% cancer recurrences in the 51 Her2/neu (3+) patients treated with GP2-GMCSF-Herceptin, when fully vaccinated with the 6 primary injection series, versus a 12% cancer recurrence rate in the 50 patient placebo arm treated with GMCSF-Herceptin (p = 0.0268).
Potent Immune Response – GP2 immunotherapy elucidated a potent immune response in HLA-A02 patients as measured by a local skin test and immunological assays. Further, booster injections given every six months prolonged the immune response thereby providing longer term protection.
Excellent Safety – In the Phase IIb and three Phase I clinical trials where 138 patients have been treated, there were no reported serious adverse events related to GP2 immunotherapy.