Clinical-stage biopharmaceutical company Grenwich Lifesciences Inc. (GLSI:NASDAQ), which focuses its work on developing GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced "the publication of a poster for the GP2 Phase 2b clinical trial final efficacy analysis at the San Antonio Breast Cancer Symposium (SABCS) in a virtual format."
The firm advised that the poster presents "the final 5 year follow-up disease-free survival curves evaluating the reduction of breast cancer recurrences for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy, or trastuzumab (Herceptin)."
The company's CEO Snehal S. Patel remarked, "The poster presented at the SABCS is important because the Kaplan Meier survival curves and demographic data further validate our promising HER2 3+ Phase IIb data and support our plan to commence a Phase 3 trial in 2021. Recurring breast cancer affects 1 in 8 women. Approximately 50% of women with recurring breast cancer do not respond to Herceptin or Kadcyla, resulting in metastatic breast cancer and a poor prognosis. Approximately 80-85% of metastatic breast cancer patients do not survive. By addressing this unmet need, GP2 may reach a potential market exceeding $5 billion."
Grenwich Lifesciences summarized the conclusions that can be drawn as outlined in the poster and stated that the trial met all of its clinical endpoints for HER2/neu 3+ patients and reduced recurrence rates to 0% in HER2/neu 3+ patients who had received a standard course of Herceptin after surgery. The company emphasized that the outcome was maintained over what it referred to as "the gold standard" of 5 years of follow-up data and observation.
The company pointed out that it believes that GP2 may also be effective when combined in tandem with Herceptin based therapeutics in HER2/neu 1-2+ patient populations or other HER2/neu expressing cancers.
The firm indicated that the Phase 2b clinical trial investigating GP2+GM-CSF which studied 168 patients across 16 clinical sites is now 100% complete with five-year follow-up. The company explained that "the trial's primary objective was to determine if treatment with GP2, a HER2-derived peptide, reduces recurrence rates."
The firm noted that the SABCS is in its 43rd year and has grown to be the premier breast cancer conference in the industry which attracts basic, translational and clinical cancer research professionals. The company said that annual attendance at the conference exceeds 7,500 health care industry professionals from over 90 countries.
The firm explained that "one in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018."
Grenwich LifeSciences is a clinical-stage biopharmaceutical company headquartered southwest of Houston in Stafford, Tex. The firm concentrates its work on the development of GP2, which it describes as "an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery." The company noted that "GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein." The company stated that GP2 has undergone four clinical trials and that none of the participants in those studies incurred any serious adverse effects from the GP2 immunotherapy. Grenwich LifeSciences advised that it now plans to advance GP2 to a Phase 3 trial that will employ a similar treatment protocol and regime as the Phase 2b study.
Grenwich Lifesciences started off the day with a market capitalization of around $62.5 million with approximately 12 million shares outstanding. GLSI shares opened more than 200% higher today at $16.07 (+$10.8713, +209.12%) over yesterday's $5.1987 closing price and reached a new 52-week high price this morning of $104.51. The stock has traded today between $12.15 to $158.07 per share and is currently trading at $129.33 (+$124.13, +2,387.12%).
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