Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) and Quantum Leap Healthcare Collaborative™ today
announced the initiation of a new study to evaluate Atossa’s
proprietary (Z)-endoxifen in combination with abemaciclib
(VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed
by Eli Lilly and Company, in women with ER+/HER2- breast cancer.
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 new study arm will enroll approximately 20 women with newly
diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth
Factor Receptor 2 negative (HER2-) invasive breast cancer.
Participants will receive 40mg (Z)-endoxifen once daily in
combination with 150mg abemaciclib twice daily for a total of 24
weeks prior to surgery.
“Endocrine therapy in combination with CDK 4/6 inhibition is a
widely used treatment for patients with advanced-stage ER+ breast
cancer and as an adjuvant therapy for node positive, hormone
positive early-stage disease, found at the time of surgical
resection,” said Dr. Laura Esserman, director of the University of
California San Francisco Breast Care Center and founder of Quantum
Leap Healthcare Collaborative. “Women with high clinical stage but
less proliferative tumors (molecularly low risk or those with late
recurrence risk) are challenging to treat. Late recurrence is high
regardless of either endocrine or chemotherapy. Thus, we are
looking for new combined treatments, which can be used in the
pre-surgery (neoadjuvant) setting. We look forward to learning more
about the potential of (Z)-endoxifen in combination with
abemaciclib in the neoadjuvant setting in the I-SPY TRIAL.”
The new study arm evaluating (Z)-endoxifen in combination with
abemaciclib is part of the ongoing I-SPY 2 Endocrine Optimization
Pilot Protocol (EOP), which targets patients with newly diagnosed
estrogen receptor-positive (ER+) invasive breast cancer whose
tumors are predicted to be sensitive to endocrine therapy but for
whom chemotherapy is expected to provide little or no benefit.
These patients have substantial risk for recurrence, often after
five years, and need novel treatments that address the risk of
recurrence and are more effective and tolerable than the current
standard of care.
“Data recently presented at the American Association for Cancer
Research (AACR) annual meeting was extremely encouraging as it
shows that (Z)-endoxifen can not only stop ER+ breast cancer from
growing, but it can also shrink or eliminate the tumor, as measured
by MRI imaging,” said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer. “Combining this activity with a targeted therapy
like CDK 4/6 inhibition, which interrupts the process through which
breast cancer cells divide and multiply, has the potential to
deliver efficacy beyond the sum of the two monotherapies. We look
forward to seeing the results of this study as it will help us
better understand which patients are best suited for mono vs.
combination therapy in the neoadjuvant setting. It will also inform
plans to potentially explore this combination in the advanced-stage
and metastatic breast cancer settings.”
Under the terms of the study agreement, Quantum Leap will
conduct the study with Atossa and Eli Lilly and Company each
responsible for supplying their respective study drugs.
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.
About Quantum Leap Healthcare
CollaborativeQuantum Leap Healthcare Collaborative is a
501c(3) charitable organization established in 2005 as a
collaboration between medical researchers at University of
California, San Francisco and Silicon Valley entrepreneurs. Our
mission is to integrate care and research, and to foster
high-impact trials with embedded clinical processes and systems
technology and improved data management, greater access to clinical
trial matching, and greater benefit to patients, providers, and
researchers. Our goal is to improve and save lives. Quantum Leap
provides operational, financial, and regulatory oversight to I-SPY.
For more information, visit https://www.quantumleaphealth.org/
About the I-SPY TRIALsThe I-SPY TRIAL
(Investigation of Serial studies to Predict Your Therapeutic
Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was
designed to rapidly screen promising experimental treatments and
identify those most effective in specific patient subgroups based
on molecular characteristics (biomarker signatures). The Endocrine
Optimization Pilot (EOP) is developing better endpoints and new
endocrine targeted agents for stage 2/3 molecularly low risk breast
cancer. The trial is a unique collaborative effort by a consortium
that includes the Food and Drug Administration (FDA), industry,
patient advocates, philanthropic sponsors, and clinicians from 30
major U.S. cancer research centers. Under the terms of the
collaboration agreement, Quantum Leap Healthcare Collaborative is
the trial sponsor and manages all study operations. For more
information, visit www.ispytrials.org
Atossa Therapeutics ContactEric Van ZantenVP,
Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
Quantum Leap Healthcare Collaborative Media
Contact:Jacqueline MurrayDirector, Marketing and
Communications(415) 839-8082j.murray@quantumleaphealth.org
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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