On February 25, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, including two corresponding posters (Press release, Greenwich LifeSciences, FEB 25, 2021, View Source [SID1234575591]). The AACR (Free AACR Whitepaper) 2021 conference will be held in a virtual format from April 10-15, 2021. The AACR (Free AACR Whitepaper) plans to publish the titles on March 10, 2021 at 4:30 pm EST, the abstracts on April 9, 2021 at 12:01 am EST, and the posters on April 10, 2021.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are pleased that both of our abstracts were accepted by the AACR (Free AACR Whitepaper). On December 9, 2020, we presented the Phase IIb clinical trial Kaplan Meier analysis of disease free survival for HER2/neu 3+ patients treated with GP2 immunotherapy, which showed 100% survival over 5 years of follow-up (0% breast cancer recurrences, p = 0.0338) if the patients received their primary GP2 treatments following surgery and Herceptin treatment. In the first abstract and poster, we are excited to present the final 5 year analysis of the immune response over time for all patients in the Phase IIb clinical trial."
Patel added, "As the immune response is the primary mechanism of action, this final analysis assessing GP2’s effectiveness in creating peak immunity is important in further validating the clinical outcome, where we observed the 0% recurrence rate, and will provide more insight into the design of the Phase III clinical trial, which is our second abstract and poster. Immune response data is critical in developing dosing and booster treatment strategies designed to achieve and sustain peak immunity, providing protection against metastatic breast cancer recurrence for as long as possible."
The first abstract and poster will present the final 5 year immune response data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical trial. The presentation will include analysis of the various methods used to measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including comparison of peak immune response versus baseline immune response at multiple time points.
The second abstract and poster, jointly sponsored with Baylor College of Medicine, will present the design of the planned Phase III clinical trial. The clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by the submission of a Biologics Licensing Application (BLA). Additional features of the clinical trial design will be presented to breast cancer key opinion leaders as we recruit clinicians and clinical sites for participation in the Phase III clinical trial.
About the AACR (Free AACR Whitepaper) Annual Meeting 2021
The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.
About Breast Cancer and HER2/neu Positivity
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. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.