- Presenting final 5 year immune response data from the Phase IIb
clinical trial for recurring breast cancer
- Planning completion of GP2 manufacturing in 2nd/3rd quarter of
2021
- Presenting updated design for Phase III clinical trial that is
planned to commence in 3rd/4th quarter of 2021
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
titles and authors of the two abstracts/posters that were accepted
for presentation at the upcoming American Association for Cancer
Research (AACR) Annual Meeting 2021, which will be held in a
virtual format from April 10-15, 2021.
The AACR plans to publish 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, “The
first AACR abstract and poster will focus on the final 5 year
analysis of the immune response over time for all patients in our
Phase IIb clinical trial. The immune response data will be critical
to finalizing the Phase III clinical trial design, including the
interim analysis and immune response monitoring strategy. For
example, one could conceivably monitor the quality of dosing at
each clinical site by monitoring immune response by clinical site,
as well as assess immune response by multiple HLA types, separating
responders from non-responders.”
Mr. Patel further added, “Sufficient manufacturing progress has
been made in the 1st quarter of 2021, such that the completion of
GP2 manufacturing is planned for 2nd/3rd quarter of 2021. Thus,
with the updated AACR data and finalization of the clinical trial
protocol and with the shipment of GP2 drug product to clinical
sites, enrollment of the first patients in the Phase III clinical
trial could commence in the 3rd/4th quarter of 2021.”
Mr. Patel concluded, “In addition to our strategy for HER2/neu
3+ patients stated above, analysis of the immune response data in
the HER2/neu low to intermediate expressing (HER2/neu 1-2+) patient
populations in our Phase IIb clinical trial may be helpful in
designing strategies to treat these patients, which include triple
negative breast cancer patients, an area of substantial unmet need.
It may be possible to design trials that combine GP2 and Herceptin
antibody drug conjugates (ADCs) with other clinically active
HER2/neu peptides and immune stimulating therapies, such as
checkpoint inhibitors. This multi-technology strategy could also be
used to treat the many other types of HER2/neu expressing
cancers.”
Final 5 Year Recurrence Rate / Disease Free Survival
Data: In December 2020, the Company presented the Phase IIb
clinical trial efficacy data, including clinical outcome and
recurrence rate data. The Kaplan Meier analysis of disease free
survival for HER2/neu 3+ patients treated with GP2 immunotherapy
showed 100% disease 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.
Final 5 Year Immune Response Data: At the upcoming AACR
2021 conference, in the first abstract and poster, the Company will
present the Phase IIb clinical trial final 5 year immune response
data over time across all patient populations to complement the
December 2020 efficacy data. The immune response is the primary
mechanism of action that is critical to developing dosing and
booster treatment strategies designed to achieve and sustain peak
immunity. The presentation will include analysis of delayed type
hypersensitivity skin tests and immunological assays used to
measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+
patient populations, such as a comparison of peak immune response
versus baseline immune response at multiple time points.
Final 5 Year Safety Data: At a future conference in 2021,
the Company plans to present the Phase IIb clinical trial final 5
year safety data. To date, the Company has administered GP2
immunotherapy to 138 patients in four clinical trials, where no
serious adverse events and a well tolerated safety profile have
been reported.
Updated Phase III Clinical Trial Design: At the upcoming
AACR 2021 conference, in the second abstract and poster, the
Company and the Baylor College of Medicine will present the updated
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 the Company and the Principal
Investigators recruit clinicians and clinical sites for
participation in the Phase III clinical trial.
The numbers, titles, and authors of the Company’s abstracts and
E-posters are as follows:
Abstract/Poster Number & Title: CT183 - Final five
year median follow-up data from a prospective, randomized,
placebo-controlled, single-blinded, multicenter, phase IIb study
evaluating a time series of immune responses using HER2/neu peptide
GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2
positive women with operable breast cancer
Authors can be viewed here:
https://www.abstractsonline.com/pp8/#!/9325/presentation/5254
Abstract/Poster Number & Title: CT256 - A
prospective, randomized, multicenter, double-blinded,
placebo-controlled phase III trial of the HER2/neu peptide GP2 +
GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy
after any trastuzumab-based therapy in HER2-positive women with
operable breast cancer
Authors can be viewed here:
https://www.abstractsonline.com/pp8/#!/9325/presentation/4862
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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version on businesswire.com: https://www.businesswire.com/news/home/20210311005391/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
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