Greenwich LifeSciences Announces Acceptance of Two Abstracts at Upcoming Major Cancer Conference

Rhea-AI Summary

Greenwich LifeSciences (Nasdaq: GLSI) announced acceptance of two abstracts for presentation at the AACR Annual Meeting 2021. The presentations will highlight GP2, an immunotherapy designed to prevent breast cancer recurrences. The first abstract discusses the final 5-year immune response analysis from the Phase IIb trial, which showed a 0% recurrence rate in HER2/neu 3+ patients. The second abstract outlines the design of the upcoming Phase III clinical trial, aiming for FDA conditional marketing approval based on interim results.

Positive

• 0% breast cancer recurrence rate observed in Phase IIb trial for HER2/neu 3+ patients after 5 years with GP2 treatment.
• Final immune response data from the Phase IIb trial supports the effectiveness of GP2 and will inform Phase III trial design.
• Plans for a Phase III clinical trial, potentially leading to FDA approval, demonstrate continued commitment to advancing GP2.

Negative

• None.

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, today announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, including two corresponding posters. The AACR 2021 conference will be held in a virtual format from April 10-15, 2021. The AACR 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.

Snehal Patel, CEO of Greenwich LifeSciences, commented, “We are pleased that both of our abstracts were accepted by the AACR. 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 Annual Meeting 2021

The AACR 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 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.

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 GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 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: www.greenwichlifesciences.com

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.

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FAQ

What are the key findings from Greenwich LifeSciences' AACR presentation about GP2?

The key findings include a 0% breast cancer recurrence rate over 5 years in HER2/neu 3+ patients treated with GP2, along with final immune response data supporting its effectiveness.

When will the AACR Annual Meeting 2021 occur?

The AACR Annual Meeting 2021 will be held virtually from April 10-15, 2021.

What is the significance of the upcoming Phase III clinical trial for GP2?

The Phase III clinical trial aims for FDA conditional marketing approval based on interim analysis, highlighting the importance of GP2 in preventing breast cancer recurrence.

How does GP2 work in preventing breast cancer recurrences?

GP2 is an immunotherapy that targets the HER2/neu protein to stimulate an immune response, effectively preventing breast cancer recurrences in treated patients.