Greenwich LifeSciences Announces Activation of Clinical Sites and Commencement of Phase III Clinical Trial | national company

STAFFORD, Texas–(BUSINESS WIRE)–August 11, 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 recurrence in post-operative patients surgery, today announced the following:

  • Phase III clinical trial, Flamingo-01, has officially begun
  • Several sites have started the selection and registration process
  • Flamingo-01 is evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in patients with HER2/neu-positive breast cancer who had residual disease or high-risk complete pathological response during surgery

CEO Snehal Patel commented, “We are excited to begin what we hope will be a successful replication of our Phase IIb trial, in which GLSI-100 safely prevented metastatic breast cancer recurrences with life-free survival. 100% disease. The hard work and efforts of the GLSI team and our partners have brought us to this major milestone. We look forward to sharing more contact information with patients and their clinicians in the future as we activate more sites and some of the largest oncology networks in the US and Europe, making Flamingo-01 accessible to as many patients as possible.

The start of the Phase III trial moves the company into pre-marketing activities, which include:

  • Work with the FDA in preparation for a BLA submission and commercial launch
  • Implement a global strategy for the launch of GP2 in international markets outside of the United States and Europe
  • Started full-scale manufacturing, packaging and marketing

The Company plans the following additional activities/steps:

  • Phase III clinical trial progress and open-label data will be presented at major conferences
  • Licensing talks could pick up speed as interim analysis nears
  • Other assets may be developed through acquisition or in-house research, including T cell therapies which may be discovered in the phase III trial by studying the robust immunogenicity of GP2
  • Additional patents for GP2 based on Phase III trial results, manufacturing and pharmacy procedures should be filed to extend patent life

For patients wishing to participate in Flamingo-01

Patients interested in participating in the Phase III Flamingo-01 clinical trial can contact the Company by email at [email protected] and can obtain clinical site contact details for contacting sites directly at www.clinicaltrials. gov with the identifier NCT05232916 (see 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 with residual disease or a high-risk complete pathological response to surgery and who have completed neoadjuvant and postoperative trastuzumab-based therapy. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from teaching hospitals and cooperative networks. In the double-blind arms of the phase III trial, approximately 500 HLA-A*02 patients will be randomized to receive 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 was designed to detect a hazard ratio of 0.3 in survival without invasive breast cancer, where 28 events will be required. An interim analysis of superiority and futility will be performed when at least half of these events, 14, have occurred. This sample size provides 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater.

About breast cancer and HER2/ new Positivity

One in eight women in the United States will develop invasive breast cancer in her lifetime, with an estimated 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/ new (human epidermal growth factor receptor 2) is a cell surface receptor protein that is expressed in a variety of common cancers, including 75% of low (1+), intermediate (2+) and high (3+ or overexpressors).

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy to prevent breast cancer recurrence in post-surgery patients. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of low (1+) breast cancers. ), intermediate (2+), and high levels (3+ or over-expressor). In a phase IIb randomized, single-blind, placebo-controlled, multicenter clinical trial conducted by MD Anderson Cancer Center, no recurrence was observed in patients treated with GLSI-100 in the HER2/neu 3+ adjuvant setting. after the median 5 years of follow-up, if patients have been treated, monitored, and remained disease-free in the first 6 months, which is the time required to reach peak immunity and therefore maximum efficacy and protection (p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date across 4 clinical trials, the treatment has been well tolerated and no serious adverse events related to immunotherapy have been observed. Greenwich LifeSciences plans to begin a Phase III clinical trial using a treatment regimen similar to that of the Phase IIb clinical trial. For more information about Greenwich LifeSciences, please visit the company’s website at www.greenwichlifesciences.com and follow the company’s Twitter at https://twitter.com/GreenwichLS.

About the immune response of GP2 immunotherapy

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

Disclaimer of Forward-Looking Statements

The 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 in this press release can be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “have the ‘intent’, ‘seek’, ‘may’, ‘could’, ‘plan’, ‘potential’, ‘predict’, ‘project’, ‘target’, ‘aim’, ‘should’, ‘will’, ‘should’ , or the negative of these words or other similar expressions, although not all forward-looking statements contain these words regarding the intended use of the net proceeds of the public offering; therefore, actual results may differ materially from those expressed or implied by such forward-looking statements.In addition, certain forward-looking statements are based on assumptions about future events which may not prove to be true.These and other risks and uncertainties are described in full below. the section entitled “Risk Factors” of the annual report uel of Greenwich LifeSciences on Form 10-K for the fiscal year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. assumes no obligation to update such information except as required by applicable law.

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CONTACT: Company Contact

Snehal Patel

Investor Relations

Office: (832) 819-3232

Email: [email protected] Contact and Public Relations for Greenwich LifeSciences

David Gentry

Companies RedChip Inc.

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

Cell: (407) 491-4498

Email: [email protected]

KEYWORD: EUROPE UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: PHARMACEUTICAL RESEARCH ONCOLOGY OTHER TRAINING OTHER MANUFACTURING TRAINING PACKAGING CLINICAL TRIALS SCIENCE SURGERY MANUFACTURING HEALTH

SOURCE: Greenwich LifeSciences, Inc.

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PUBLISHED: 08/11/2022 10:30 a.m. / DISK: 08/11/2022 10:32 a.m.

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