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Greenwich LifeSciences (GLSI) Reports Robust Immune Response Phase IIb Data Supporting GP2 Clinical Outcome of 0% Metastatic Breast Cancer Recurrences Over 5 Years of Follow-up

April 9, 2021 6:12 AM EDT

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 the abstract results of the final 5 year immune response data of the Phase IIb clinical trial at the 2021 AACR Annual Meeting. Immune response is the primary mechanism of action and is critical to developing dosing and booster treatment strategies that are designed to achieve and sustain peak immunity and to prevent metastatic breast cancer recurrences.

  • Abstract published today at the American Association for Cancer Research (AACR) Annual Meeting shows the GP2 final 5 year immune response data from the Phase IIb clinical trial.
  • Poster showing graphs of immune response data over time will be published by AACR on Saturday, April 10th at 8:30 am ET. The Company plans to publish the poster, the abstract, and an audio recording in a joint press release on April 10th.
  • Potent immune response data supports the previously reported clinical outcome of 0% metastatic breast cancer recurrences over 5 years of follow-up.
  • Statistically significant peak immunity was reached after 6 months of GP2 treatment as measured in both a GP2 specific CD8 T cell dimer binding assay and a delayed-type-hypersensitivity (DTH) skin test.
  • HER2 3+ population immune response was similar to the HER2 1-2+ population immune response, suggesting the potential to treat the HER2 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents.
  • Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat other HER2 1-3+ expressing cancers.

The AACR published the Phase IIb final 5 year immune response data abstract on Friday, April 9th and plans to publish the corresponding poster on Saturday, April 10th. The poster, the abstract, and an audio recording will be published by the Company on Saturday, April 10th in a joint press release.

Summary of Additional Upcoming Posters/Press Releases:

Week of April 12th – Press release of the second poster at AACR, co-sponsored by the Company and the Baylor College of Medicine, will provide more details behind the updated design of the planned Phase III clinical trial.

Week of June 4th – The Company will present two abstract/poster presentations at the 2021 American Society of Clinical Oncology (ASCO) conference. The poster presentations will include the final 5 year safety data of the GP2 Phase IIb clinical trial and an introduction to the interim analysis and clinical strategy of the planned Phase III clinical trial.



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