On December 29, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following year end update (Press release, Greenwich LifeSciences, DEC 29, 2022, View Source [SID1234625662]).
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SABCS Update & New Flamingo-01 Steering Committee
At the 2022 San Antonio Breast Cancer Symposium (SABCS), the Company met with the Flamingo-01 Steering Committee and met with clinicians from the US and various countries in Europe who are participating or planning to participate in Flamingo-01.
The Steering Committee is comprised of the following members and may be expanded as Flamingo-01 is expanded into Europe:
Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sara A. Hurvitz – Professor of Medicine at the David Geffen School of Medicine at UCLA, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, Co-Director of the Santa Monica-UCLA Outpatient Oncology Practices, Director of the Breast Cancer Clinical Trials Program at UCLA, and Chief Medical Officer of TRIO-US
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Rimawi, Chair of the Steering Committee, commented, "We are excited about having initiated this trial. We believe that GP2 carries great potential to improve outcomes for patients with HER2 positive breast cancer. With growing interest and excitement about treatments that boost the immune response to cancer, this trial is as timely as it is innovative, and we look forward to conducting it with the exceptional team of investigators we will be collaborating with in Flamingo-01."
CEO Snehal Patel commented, "We were very encouraged by the meetings held at SABCS with clinicians who are participating in or interested in participating in Flamingo-01. The Company will continue to focus on opening more clinical sites than the 20 sites currently opened in the US, expanding Flamingo-01 into the largest countries in Europe, and enrolling and treating patients. We encourage potential patients to reach out to the clinical sites directly or to email the Company."
Clinical Sites Participating in Flamingo-01 Phase III Clinical Trial
Approximately 20 clinical sites with 63 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients. The Company has added a new page to its website to provide updates to Flamingo-01 which includes a map of participating clinical sites in the US (view here).
Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can contact the Company by email at:
Patients can obtain the latest clinical site contact information to contact sites directly on www.clinicaltrials.gov with identifier NCT05232916 (view here, then click on "Contacts and Locations" near the top right corner or near the bottom of the web page). The current listing of US sites from www.clinicaltrials.gov with email contact information for some sites is also shown below and will be continually updated during the trial:
Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Principal Investigator: Erica Stringer-Reasor, MD
Arizona
Arizona Oncology Associates, PC – HOPE
Tucson, Arizona, United States, 85745
Contact: Stacey Kimbell, R.N. [email protected]
Principal Investigator: Aisha Ahmed, MD
California
University of Southern California
Los Angeles, California, United States, 90033
Principal Investigator: Danielle Sterrenberg, MD
University of California, Los Angeles
Los Angeles, California, United States, 90404
Principal Investigator: Sara Hurvitz
Torrance Memorial Physicians Network
Torrance, California, United States, 90505
Principal Investigator: David Chan, MD
PIH Hospital – Whittier
Whittier, California, United States, 90602
Principal Investigator: Lisa Wang, MD
Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
Principal Investigator: Mabel Mardones, MD
Florida
University of Miami
Coral Gables, Florida, United States, 33146
Principal Investigator: Mauricio Escobar, MD
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Principal Investigator: Nikita Shah, MD
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Principal Investigator: Aixa Soyano, MD
Maryland
Maryland Oncology Hematology (USOR)
Annapolis, Maryland, United States, 21401
Principal Investigator: Jeanine Werner, MD
Nebraska
Nebraska Cancer Specialists (USOR)
Omaha, Nebraska, United States, 68114
Contact: Heather Cordes [email protected]
Principal Investigator: Mary Wells, MD
Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Principal Investigator: Stephani Christensen, MD
New York
Columbia University
New York, New York, United States, 10032
Contact: [email protected]
Principal Investigator: Julia McGuinness, MD
Stony Brook University
Stony Brook, New York, United States, 11794
Principal Investigator: Jules Cohen, MD
Oregon
Compass Oncology (USOR)
Tigard, Oregon, United States, 97223
Contact: Jennifer Thompson [email protected]
Principal Investigator: Jay Andersen, MD
Texas
Texas Oncology – Austin
Austin, Texas, United States, 78745
Contact: Sara Manning [email protected]
Principal Investigator: Debra A Patt, MD
Texas Oncology – Dallas (USOR)
Dallas, Texas, United States, 75246
Contact: Christine Terraciano [email protected]
Principal Investigator: Cynthia Osborne, MD
Baylor College of Medicine
Houston, Texas, United States, 77057
Contact: Mothaffar Rimawi, MD
Principal Investigator: Mothaffar Rimawi, MD
Texas Oncology San Antonio (USOR)
San Antonio, Texas, United States, 78240
Contact: Shannon Syring [email protected]
Principal Investigator: Emmalind Aponte, MD
Texas Oncology – Tyler (USOR)
Tyler, Texas, United States, 75702
Principal Investigator: Nanna Sulai, MD
Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Principal Investigator: Shruti Tiwari, MD
The Colorado and Alabama sites listed above are not yet recruiting. An additional 10 sites near the following locations may be activated in the future: San Francisco, Boston, Chicago, Philadelphia, Houston, Cincinnati, Albany, Dallas, Omaha, and New Haven. Negotiations are under way to add an additional 60-75 sites in Europe, bringing the total number of potential sites in Flamingo-01 to over 90 sites.
Flamingo-01 Enrollment & Open Label Data
Future updates or abstracts/posters may include the patient enrollment status of the trial and potentially open label data results.
Mr. Patel further added, "We look forward to analyzing open label data, which may include injection site reactions, delayed type hypersensitivity testing, and immune response data as they become available by HLA type. The objective, although there is no assurance that any of this will be possible, is to assess how Flamingo-01 is progressing compared to the Phase IIb trial, where no recurrences were observed in the GP2 treated patients as previously reported. Along the way, the treatment of patients of different HLA types and the use of new T cell identification technologies may provide additional insights into GP2’s mechanism of action and market potential, including potential additional intellectual property for the Company."
Commercial Manufacturing & New Intellectual Property
In the fourth quarter of 2022, the Company initiated commercial manufacturing activities, which, if successful, would lead to the completion of the first 3 commercial lots of GP2 active ingredient in 2023 and which in total could be used to prepare approximately 200,000 doses of GP2. These commercial lots would be submitted to the FDA in the US and other regulatory agencies in Europe when a marketing application is filed seeking approval to sell GP2 in these respective locations.
In the fourth quarter of 2022, a new patent application was filed with regards to the use of GP2 in an immune response assay that could be used as a biomarker. Plans are in place to potentially file additional patent applications with regards to the use of GP2 in treating patients and with regards to GP2 manufacturing, pharmacy, or injection processes.
IR Calendar, Bloomberg Interview, & Updated Corporate Presentation Webcast
The Company’s events over the past 6 months can be seen on the events calendar (view here), which include Jefferies and Wainwright investor conferences, BIO Europe partnering conference, Susan G. Komen Race for Cure, and an interview of CEO Patel aired on Bloomberg (view here). The corporate presentation has also been updated, and the webcast will be updated shortly (view here).
About Flamingo-01 and GLSI-100
Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. 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.