Greenwich LifeSciences Reports Robust Immune Response Phase IIb Data Supporting GP2 Clinical Outcome of 0% Metastatic Breast ...
April 09 2021 - 5:00AM
Business Wire
- 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.
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.
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.
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 at www.greenwichlifesciences.com and follow the
Company's Twitter at https://twitter.com/GreenwichLS.
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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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
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