- The GP2 Phase III clinical trial design was presented in a
poster during the 2021 American Association for Cancer Research
(AACR) Annual Meeting, introduced by the Global Principal
Investigator, Professor Mothaffar F. Rimawi of Baylor College of
Medicine.
- The Company plans to complete manufacturing of GP2 by the end
of the 3rd quarter 2021 and plans to commence the Phase III
clinical trial thereafter.
- A third open-label arm has been added to the Phase III trial to
test GP2 in HLA types other than HLA-A02 and to assess immune
response and clinical outcome. This third arm will function similar
to a Phase II trial, thus creating potential for early immune
response data analysis and proof of concept that GP2 can treat
other HLA types, which would expand GP2’s market by HLA type from
50% up to 80% or more.
- In some clinical sites for the Phase III trial, up to 8 immune
response tests will be taken over time to assess immune response
beyond the 2.5 years tracked in the Phase IIb trial, thus providing
additional high quality immune response data to help identify
responders and correlations to clinical outcome.
- The Phase III trial design will include an event-driven interim
analysis for superiority or futility. This analysis will be
conducted when approximately half of the expected breast cancer
recurrences have occurred, which may allow for submission of a
Biologics Licensing Application (BLA) to the FDA for conditional
marketing approval of GP2 approximately halfway through the
trial.
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
publication of a second poster for the GP2 Phase III clinical trial
design for recurring breast cancer at the 2021 AACR Annual Meeting.
The Global Principal Investigator of the GP2 Phase III clinical
trial, Dr. Mothaffar F. Rimawi of the Dan L Duncan Comprehensive
Cancer Center at Baylor College of Medicine, is the lead author of
the poster and has recorded an audio track providing an
overview.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210414005362/en/
Poster Presentation CT256 from 2021 AACR
Annual Meeting Showing GP2 Phase III Clinical Trial Design for
Recurring Breast Cancer (Graphic: Business Wire)
The AACR published the Phase III trial design abstract on April
9, 2021 and the poster on April 10, 2021. The abstract can be
viewed at the bottom of this press release and the full poster with
audio can be accessed or downloaded on the Company website at
https://greenwichlifesciences.com/clinical-trials/#Phase-III.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “At
present, the Phase III trial is designed to treat up to 500
patients. The data read out for the interim analysis will be event
driven and could be completed approximately halfway through the
planned 5 year follow-up. The recently reported robust immune
response data, which peaked after 6 months in the Phase IIb trial,
will help to finalize the Phase III trial design, including the
immune response monitoring strategy. We will also assess immune
response in an open-label third arm across multiple HLA types to
potentially expand the market for GP2. This immune response data
could be reported before the interim analysis.”
Updated Phase III Clinical Trial Design: The Company and
the Baylor College of Medicine presented the updated design of the
planned Phase III clinical trial to breast cancer key opinion
leaders. The Phase III clinical trial is a prospective, randomized,
double-blinded, multi-center trial. The primary efficacy endpoints
for the three arms of the Phase III trial are invasive Disease Free
Survival (iDFS). The objective is to conservatively reproduce the
Phase IIb trial results which demonstrated 100% iDFS with 5 years
of follow-up in the HER2/neu 3+ population.
In addition to the trial design updates in the bullet points
above, patients meeting all entry criteria will be randomized to
receive either GP2 + GM-CSF or placebo. The Phase III trial design
includes the use of saline in the placebo arm, instead of GM-CSF,
which was used in the placebo arm of the Phase IIb trial. GM-CSF is
not the standard of care and may cause immune responses in placebo
patients.
Dr. Jaye Thompson, VP of Clinical and Regulatory Affairs, added,
“It is critical that the study population and design in the
protocol are carefully crafted so that the resulting data provides
convincing evidence of safety and efficacy for the BLA submission.
We have already engaged a statistician to design the interim
analysis and have begun recruiting clinicians and clinical sites
for participation in the Phase III trial.”
AACR Abstract CT256
Title: 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
Snehal S Patel1, David B McWilliams1, Christine T Fischette1,
Jaye Thompson1, F Joseph Daugherty1, C Kent Osborne2 and Mothaffar
F Rimawi2.
1Greenwich LifeSciences, Stafford, TX; 2Baylor College of
Medicine, Houston, TX
Background: GP2 is a
biologic nine amino acid peptide of the HER2/neu protein delivered
in combination with an FDA-approved immunoadjuvant
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF,
Sargramostim, Leukine) that stimulates an immune response targeting
HER2/neu expressing cancers. In a prospective, randomized,
single-blinded, placebo-controlled, multicenter Phase IIb clinical
trial completed in 2018, no recurrences were observed in the
HER2/neu positive adjuvant setting after median 5 years of
follow-up, if the HLA 2+ patient received the 6 primary intradermal
injections over the first 6 months (p = 0.0338) in a pre-specified
subgroup analysis. Furthermore, the GP2 immunotherapy elicited a
potent immune response measured by local skin tests and
immunological assays. 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
the GP2 immunotherapy. This Phase III trial aims to reproduce the
Phase IIb study and will explore the use of GP2 + GM-CSF as
adjuvant therapy to prevent the recurrence of breast cancer in
HER2/neu positive and HLA 2+ patients, post-surgery and following
the first year treatment with any trastuzumab-based therapy.
Trial Design: This Phase III
trial is a prospective, randomized, double-blinded, multi-center
study. After 1 year of trastuzumab-based therapy or an approved
biosimilar, treatment with GP2 + GM-CSF or placebo (Bacteriostatic
Saline/WFI) will be administered intradermally for the 6 primary
immunization series over the first 6 months and 5 subsequent
boosters over the next 2.5 years for a total of 11 injections over
3 years of treatment. The participant duration of the trial will be
3 years treatment plus 2 years follow-up for a total of 5 years
following the first year treatment with trastuzumab-based therapy
or approved biosimilar. An interim analysis is planned and patients
will be stratified based on prior and current treatments, among
other factors.
Eligibility Criteria: The
majority of breast cancer patients will be HER2/neu positive and
HLA 2+, disease-free, conventionally treated node-positive, post
breast tumor removal surgery and following the first year treatment
with trastuzumab-based therapy.
Trial Objectives:
- To determine if GP2 therapy reduces recurrence in HER2/neu
positive breast cancer patients.
- To monitor the in vitro and in vivo immunologic responses to
GP2 therapy and correlate these responses with the clinical
outcomes.
- To monitor for any unexpected adverse events and toxicities
related to GP2 therapy.
Accrual: The target
enrollment is up to approximately 500 patients.
Funding: This trial is
supported by Greenwich LifeSciences.
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 at www.greenwichlifesciences.com and follow the
Company's Twitter at https://twitter.com/GreenwichLS.
About GP2 Immunotherapy Immune Response
As previously reported, GP2 immunotherapy generated GP2-specific
immune responses, leading to no metastatic breast cancer recurrence
in the HER2/neu 3+ population in the Phase IIb clinical trial, thus
supporting GP2’s mechanism of action. Statistically significant
peak immunity was reached after 6 months of GP2 treatment, as
measured in both the Dimer Binding Assay and the DTH skin test.
HER2/neu 3+ population immune response was similar to the HER2/neu
1-2+ population immune response, suggesting the potential to treat
the HER2/neu 1-2+ population (including triple negative breast
cancer) with GP2 immunotherapy in combination with trastuzumab
(Herceptin) based products and other clinically active agents. The
broad based immune response suggests the potential for GP2 to treat
other HER2/neu 1-3+ expressing cancers. For more information on GP2
immune response and clinical data, please visit the Company’s
clinical trial tab at
https://greenwichlifesciences.com/clinical-trials/#Phase-IIb-AACR.
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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