Atossa Therapeutics Announces Sponsored Research Agreement with Weill Cornell Medicine to Address Treatment Challenges in Triple Negative Breast Cancer
2023年7月6日 - 10:15PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative proprietary
medicines to address significant unmet needs in oncology with a
focus on breast cancer, today announces a strategic, sponsored
research agreement with Weill Cornell Medicine to study the
potential of inducing estrogen receptor (ER) expression in
triple-negative breast cancer (TNBC). The goal of this research is
to determine if treating TNBC with extracellular vesicles carrying
the ER will convert the tumor to ER+ and render it sensitive to
treatment with Selective Estrogen Receptor Modulators (SERM),
including Atossa’s proprietary (Z)-endoxifen.
The research project will be led by David Lyden, M.D., Ph.D.,
the Stavros S. Niarchos Professor in Pediatric Cardiology and
Director of the Department of Pediatrics’ Physician Scientist
Training Program at Weill Cornell Medicine. Dr. Lyden’s laboratory
is focused on the molecular pathways activated by tumor
extracellular vesicle uptake at the metastatic site and identifying
potential therapeutic targets to thwart metastasis. His work has
led to a new understanding of how primary tumor cells dictate their
own metastases, by decoding how cancer-derived extracellular
vesicles mediate intercellular communication. Most recently, Dr.
Lyden has identified specific extracellular vesicle subpopulations
and discovered a new subset of particles known as exomeres, which
collectively have distinct functional roles in the systemic effects
of cancer.
“We look forward to working with Atossa and think this project
could provide proof of principle for novel approaches to estrogen
receptor reinduction in triple negative breast cancer,” said Dr.
Lyden. “If we are able to change the cancer phenotype and turn on
the estrogen receptor, we could then treat these patients with
hormone therapy, which is more effective than currently approved
treatments for triple-negative breast cancer.”
“Triple-negative breast cancer grows and spreads faster than
other forms of breast cancer, disproportionately affects Black and
Hispanic women and has a higher risk of recurrence,” said Dr.
Steven Quay, Atossa’s President and Chief Executive Officer. “It’s
called triple-negative breast cancer because it does not have any
of the receptors that are commonly found in most breast cancers.
This makes triple-negative breast cancer particularly difficult to
treat because drugs that target estrogen, progesterone, or the
human epidermal growth factor protein are ineffective. Activating
the estrogen receptor and converting the tumor to ER+ would
fundamentally transform the treatment paradigm for these
patients.”
About Triple-Negative Breast
CancerTriple-negative breast cancer (TNBC) accounts for
about 10-15% of all breast cancers, which amounts to almost 200,000
cases worldwide each year. The term triple-negative breast cancer
refers to the fact that the cancer cells don’t have estrogen or
progesterone receptors (ER or PR) and also don’t make any or much
of the human epidermal growth factor receptor 2 (HER2) protein. The
tumor cells test "negative" on all three tests. These cancers tend
to be more common in women who are younger than age 40, are Black
or Hispanic, or who have a BRCA1 mutation. TNBC differs from other
types of invasive breast cancer in that it tends to grow and spread
faster, has fewer treatment options, has a higher risk of
recurrence, and tends to have a worse prognosis.
About (Z)-Endoxifen(Z)-endoxifen is the most
active metabolite of the FDA approved Selective Estrogen Receptor
Modulator (SERM), tamoxifen. Studies by others have demonstrated
that the therapeutic effects of tamoxifen are driven in a
concentration-dependent manner by (Z)-endoxifen. In addition to its
potent anti-estrogen effects, (Z)-endoxifen at higher
concentrations has been shown to target PKCβ1, a known oncogenic
protein.
Atossa is developing a proprietary oral formulation of
(Z)-endoxifen that does not require liver metabolism to achieve
therapeutic concentrations and is encapsulated to bypass the
stomach as acidic conditions in the stomach convert a greater
proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s
(Z)-endoxifen has been shown to be well tolerated in Phase 1
studies and in a small Phase 2 study of women with breast cancer.
We are currently studying (Z)-endoxifen in three Phase 2 studies:
one in healthy women with measurable breast density and two other
studies including the EVANGELINE study in women with ER+/HER2-
breast cancer. Atossa’s (Z)-endoxifen is protected by three issued
U.S. patents and numerous pending patent applications.
About Atossa TherapeuticsAtossa Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing
innovative medicines in areas of significant unmet medical need in
oncology with a focus on breast cancer. For more information,
please visit www.atossatherapeutics.com.
CONTACT:Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSForward-looking
statements in this press release, which Atossa undertakes no
obligation to update, are subject to risks and uncertainties that
may cause actual results to differ materially from the anticipated
or estimated future results, including the risks and uncertainties
associated with any variation between interim and final clinical
results, actions and inactions by the FDA, the outcome or timing of
regulatory approvals needed by Atossa including those needed to
commence studies of (Z)-endoxifen, lower than anticipated rate of
patient enrollment, estimated market size of drugs under
development, the safety and efficacy of Atossa’s products,
performance of clinical research organizations and investigators,
obstacles resulting from proprietary rights held by others such as
patent rights, whether reduction in breast density or in Ki-67 or
any other result from a neoadjuvant study is an approvable endpoint
for (Z)-endoxifen, whether Atossa can complete acquisitions, and
other risks detailed from time to time in Atossa’s filings with the
Securities and Exchange Commission, including without limitation
its periodic reports on Form 10-K and 10-Q, each as amended and
supplemented from time to time.
Atossa Therapeutics (NASDAQ:ATOS)
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