Greenwich LifeSciences Announces Commencement of the First Commercial Line Filling of GP2
December 06 2021 - 7:15AM
Business Wire
- The first commercial line filling of GP2 was commenced today,
setting the scale and path forward for commercial manufacturing of
GP2.
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 provides
manufacturing and clinical updates on Phase III clinical trial
FLAMINGO-01.
Over the past six months, the Company has been actively
selecting and contracting partners to manufacture clinical and
commercial lots of GP2 and to manage the Phase III clinical trial.
An update on these activities follows:
- Today, the Company ran its first commercial fill line of GP2 at
its fill and finish partner’s production facility with sufficient
scale to produce up to 80,000 doses of GP2 per lot. Three
commercial lots of GP2 will be required to file a Biologics License
Application (BLA) for GP2. The three lots combined should treat
approximately 22,000 patients, and in the initial GP2 indication,
approximately 17,000 new patients could be treated per year, saving
up to 1,500 to 2,000 lives per year.
- Clinical research organization (CRO) has been engaged to manage
the Phase III clinical trial.
- GP2 active ingredient manufacturer has been engaged to produce
commercial scale GP2 lots.
- Commercial testing laboratory has been engaged to release
clinical and commercial GP2 lots and to manage GP2 stability
program.
- In addition to their operational role, these partners will play
a key role in preparing the manufacturing and clinical information
necessary to submit a BLA upon a successful interim analysis of the
Phase III clinical trial.
- Partners for HLA typing, blood test collection, GP2 storage and
distribution, GM-CSF distribution, immune response testing, and
blood sample storage have been selected to support the Phase III
clinical trial.
CEO Snehal Patel commented, “Commencing commercial scale
manufacturing is a major milestone for the Company. We are
carefully selecting partners who are leaders in the industry with
whom we hope to work with over the long term. At the same time, the
Company is developing a back-up strategy by location and function
to reduce risk and provide multiple options going forward. In
addition, all of the various parties required to operate the Phase
III clinical trial testing, storage, and distribution activities
have been integrated well through our management team and CRO. The
expertise of our partners has served to enhance the quality and
accelerate the progress of our manufacturing and clinical
plans.”
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the
combination of GP2 + GM-CSF will be called GLSI-100. The Phase III
trial is comprised of 2 blinded, randomized, placebo-controlled
arms for approximately 500 HLA-A*02 patients and 1 open label arm
of up to 100 patients for all other HLA types. An interim analysis
has been designed to detect a hazard ratio of 0.3 in IDFS, where 28
events will be required. An interim analysis for superiority and
futility will be conducted when at least half of those events, 14,
have occurred. This sample size provides 80% power if the annual
rate of events in placebo-treated subjects is 2.4% or greater. The
trial is currently being registered on clinicaltrials.gov and the
link and trial identifier will be published shortly. For future
updates about FLAMINGO-01 please visit the Company’s clinical trial
tab at https://greenwichlifesciences.com/clinical-trials/.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over
her lifetime, with approximately 282,000 new breast cancer patients
and 3.8 million breast cancer survivors in 2021. 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 GLSI-100 to date over 4
clinical trials, treatment was well tolerated and no serious
adverse events were observed related to the 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/.
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/20211206005316/en/
Company Contact Snehal Patel Investor Relations Office:
(832) 819-3232 Email: 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 Email:
dave@redchip.com
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