Atossa Therapeutics Announces Expanded Research Agreement with Weill Cornell Medicine to Further Evaluate Synergy Between Antibody Drug Conjugates (ADCs) and (Z)-Endoxifen
29 Abril 2024 - 7:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) today announced an expanded research agreement with
Weill Cornell Medicine to explore the potential synergy between
antibody drug conjugates (ADCs) and (Z)-endoxifen. Atossa is a
clinical stage biopharmaceutical company developing innovative
medicines in areas of significant unmet medical need in oncology
with a focus on breast cancer.
The expanded research agreement with Weill Cornell will build on
previously conducted in silico research that determined a strong
clinically relevant anti-tumor effect when combining ADCs and
(Z)-endoxifen. Specifically, the artificial intelligence modeling
showed that the combination of (Z)-endoxifen with ADCs will enhance
the pro-apoptotic effects seen after administration of either
therapy alone. This computer-based analysis was further validated
by previously published preclinical studies looking at the effect
of selective estrogen receptor modulator (SERM) and chemotherapy
combination strategies. Seven key opinion leaders also confirmed
the strong scientific rationale and proposed efficacy of combining
(Z)-endoxifen with ADCs in patients with advanced breast
cancer.
ADCs are a specially designed class of therapeutics that target
cancer cells expressing specific antigens using directed
antibody-drug delivery. The therapies bind to targets on the cell,
causing the release of a cytotoxic drug designed to kill the cancer
cell. The Weill Cornell research will focus on the combination of
(Z)-endoxifen and two FDA-approved ADCs, TRODELVY® and ENHERTU®.
Both are currently approved as monotherapies to treat metastatic
breast cancer. Additionally, TRODELVY is approved to treat adults
with metastatic bladder and urinary tract cancers.
“The in silico modeling analysis identified multiple synergistic
mechanism of actions of ADCs and (Z)-endoxifen, including cell
cycle arrest and upregulation of pro-apoptotic mechanisms,” said
Dr. Steven Quay, Atossa’s President and Chief Executive Officer.
“This means that the combination may be far greater than the sum of
the individual parts. The work we are doing with Weill Cornell is
designed to validate the in silico modeling in well-established
cell culture models of breast cancer. Once we have this data, we
expect to move quickly into a clinical study investigating a
(Z)-endoxifen / ADC combination in patients with late-line
metastatic breast cancer.”
About (Z)-Endoxifen(Z)-endoxifen is the most
potent Selective Estrogen Receptor Modulator (SERM) for estrogen
receptor inhibition and also causes estrogen receptor degradation.
It has also been shown to have efficacy in the setting of patients
with tumor resistance to other hormonal treatments. In addition to
its potent anti-estrogen effects, (Z)-endoxifen has been shown to
target PKCβ1, a known oncogenic protein, at clinically attainable
blood concentrations. Finally, (Z)-endoxifen appears to deliver
similar or even greater bone agonistic effects while resulting in
little or no endometrial proliferative effects compared with
standard treatments, like tamoxifen.
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 significant
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.
(Z)-endoxifen is currently being studied in four Phase 2 trials:
one in healthy women with measurable breast density, one in women
diagnosed with ductal carcinoma in situ, 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 using (Z)-endoxifen to prevent and treat
breast cancer. For more information, please visit
www.atossatherapeutics.com.
TRODELVY® and ENHERTU® are registered trademarks of Gilead
Sciences and Daiichi Sankyo Company, Limited, respectively.
Contact:Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSThis press release
contains certain information that may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. We may identify these forward-looking
statements by the use of words such as “expect,” “potential,”
“continue,” “may,” “will,” “should,” “could,” “would,” “seek,”
“intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or
other comparable words. Forward-looking statements in this press
release are subject to risks and uncertainties that may cause
actual results, outcomes, or the timing of actual results or
outcomes, including the timing of data related to the (Z)-endoxifen
program, the potential of (Z)-endoxifen as a breast cancer
prevention and treatment agent, and the potential safety and
tolerability profile of (Z)-endoxifen, to differ materially from
those projected or anticipated, including risks and uncertainties
associated with: macroeconomic conditions and increasing
geopolitical instability; the expected timing of releasing data;
any variation between interim and final clinical results; actions
and inactions by the FDA and foreign regulatory bodies; the outcome
or timing of regulatory approvals needed by Atossa, including those
needed to continue our planned (Z)-endoxifen trials; our ability to
satisfy regulatory requirements; our ability to comply with the
continued listing requirements of the Nasdaq Stock Market; our
ability to successfully develop and commercialize new therapeutics;
the success, costs and timing of our development activities,
including our ability to successfully initiate or complete our
clinical trials, including our (Z)-endoxifen trials; our
anticipated rate of patient enrollment; our ability to contract
with third-parties and their ability to perform adequately; our
estimates on the size and characteristics of our potential markets;
our ability to successfully defend litigation and other similar
complaints and to establish and maintain intellectual property
rights covering our products; whether we can successfully complete
our clinical trial of oral (Z)-endoxifen in women with mammographic
breast density and our trials of (Z)-endoxifen in women with breast
cancer, and whether the studies will meet their objectives; our
expectations as to future financial performance, expense levels and
capital sources, including our ability to raise capital; our
ability to attract and retain key personnel; our anticipated
working capital needs and expectations around the sufficiency of
our cash reserves; and other risks and uncertainties detailed from
time to time in Atossa’s filings with the Securities and Exchange
Commission, including without limitation its Annual Reports on Form
10-K and Quarterly Reports on 10-Q. Forward-looking statements are
presented as of the date of this press release. Except as required
by law, we do not intend to update any forward-looking statements,
whether as a result of new information, future events or
circumstances or otherwise.
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