Greenwich LifeSciences Announces Acceptance of Two Posters at Upcoming 2021 SABCS Breast Cancer Conference

Rhea-AI Summary

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announced the acceptance of two abstracts and posters for presentation at the San Antonio Breast Cancer Symposium (SABCS) scheduled for December 7-10, 2021. The posters will highlight data from their ongoing Phase IIb clinical trial of GLSI-100, their immunotherapy aimed at preventing breast cancer recurrence. CEO Snehal Patel emphasized the significance of this data, citing a 100% disease-free survival rate over five years. The Phase III trial, FLAMINGO-01, is set to commence, targeting approximately 500 patients.

Positive

• Acceptance of two abstracts for presentation at SABCS, indicating recognition within the medical community.
• Demonstrated 100% disease-free survival rate over five years from Phase IIb trials, suggesting potential efficacy of GLSI-100.
• Plans for enhanced immune response technology and increased testing frequency in upcoming Phase III trials, potentially leading to improved outcomes.

Negative

• None.

STAFFORD, Texas--(BUSINESS WIRE)-- 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, today announced that two abstracts and posters have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS).

SABCS 2021 will be held in a hybrid in-person and virtual format from December 7-10, 2021. SABCS anticipates publishing the two posters on the evening of December 8, 2021.

Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are thrilled to be presenting our 4th poster of our 5 year Phase IIb data at SABCS, completing a full year of publications. This data is a result of our ongoing data analysis and will speak to the mechanism of GP2 and the potential to use immune response data in novel ways. As a result of our previously published immune response data and this upcoming data, we plan to substantially improve the immune response technology and to increase the frequency of testing and sample collection in our Phase III trial. This data will be published on the 1 year anniversary of our initial poster at SABCS showing the 100% disease free survival or 0% metastatic breast cancer recurrence rate over 5 years of follow-up.”

The second abstract and poster will present additional features of the Phase III clinical trial providing information to breast cancer clinicians who will be attending the in-person conference, visiting our poster session, and participating in our first Phase III trial investigator meeting where the global primary investigator and the Company will present the trial to participating clinicians.

About SABCS

The 44th annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. For more information, please visit the conference website at: https://www.sabcs.org/

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, 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. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.

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.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is 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. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GLSI-100 to date over 4 clinical trials, treatment was well tolerated and no serious adverse events were observed related to the immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS.

About GP2 Immunotherapy Immune Response

As previously reported, GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2’s mechanism of action. Statistically significant peak immunity was reached after 6 months of GP2 treatment, as measured in both the Dimer Binding Assay and the DTH skin test. HER2/neu 3+ population immune response was similar to the HER2/neu 1-2+ population immune response, suggesting the potential to treat the HER2/neu 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents. The broad based immune response suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. For more information on GP2 immune response and clinical data, please visit the Company’s clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211111005490/en/

Company Contact

Snehal Patel

Investor Relations

(832) 819-3232

info@greenwichlifesciences.com



Investor & Public Relations Contact for Greenwich LifeSciences

Dave Gentry

RedChip Companies Inc.

Office: 1-800-RED CHIP (733 2447)

Cell: (407) 491-4498

dave@redchip.com

Source: Greenwich LifeSciences, Inc.

FAQ

What abstracts will Greenwich LifeSciences present at SABCS 2021?

Greenwich LifeSciences will present two abstracts related to their Phase IIb clinical trial of GLSI-100, their immunotherapy for preventing breast cancer recurrence.

When is the San Antonio Breast Cancer Symposium (SABCS) taking place?

SABCS 2021 will be held from December 7-10, 2021.

What is the significance of the Phase IIb data being presented?

The Phase IIb data includes a 100% disease-free survival rate over five years, highlighting the potential effectiveness of GLSI-100.

What is the FLAMINGO-01 trial?

FLAMINGO-01 is the upcoming Phase III clinical trial for GLSI-100, involving approximately 500 patients.

Who is the CEO of Greenwich LifeSciences?

The CEO of Greenwich LifeSciences is Snehal Patel.