Atossa Therapeutics and Quantum Leap Healthcare Collaborative Dose First Patient in I-SPY 2 Trial Combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- Breast Cancer
21 August 2024 - 10:30PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) and Quantum Leap Healthcare Collaborative™ (QLHC), today
announced the first patient has been dosed in their clinical trial
evaluating Atossa’s proprietary (Z)-endoxifen in combination with
abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6
inhibitor marketed by Eli Lilly and Company, as a neoadjuvant
treatment in high-risk women with newly diagnosed Estrogen Receptor
positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative
(HER2-) breast cancer. Atossa is a clinical stage biopharmaceutical
company developing innovative medicines in oncology with a focus on
breast cancer.
The study evaluating (Z)-endoxifen in combination with
abemaciclib is part of the ongoing I-SPY 2 Endocrine Optimization
Pilot Protocol (EOP), which focuses on 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 are more effective and
tolerable than the current standard of care.
The combination study, being conducted across the I-SPY network,
will enroll approximately 80 participants across two 40-participant
cohorts. Both cohorts will include pre-and-post menopausal women
who will receive 80 mg (Z)-endoxifen once daily in combination with
150 mg abemaciclib twice daily for 24 weeks prior to surgery.
Premenopausal women in the second cohort will also receive ovarian
function suppression (OFS). The addition of OFS in premenopausal
women enrolled in the second cohort of the study will assess the
impact of OFS with this combination. Data from the study,
anticipated in 2026, is expected to further validate the growing
body of evidence that (Z)-endoxifen is safe and highly efficacious
in both premenopausal and postmenopausal breast cancer
patients.
“Dosing the first patient in this trial marks a significant
milestone for Atossa in support of our important partnership with
the QLHC,” said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer. “The innovative idea of combining (Z)-endoxifen
and abemaciclib in the neoadjuvant setting can open the door to the
development of gentler more patient-friendly treatment options for
women with invasive breast tumors. By combining these therapies, we
hope to achieve improved outcomes compared to available therapies,
not only in terms of safety and efficacy, but also with respect to
patients’ quality of life outcome measures.”
“We are excited to announce that the first patient has been
dosed in this clinical trial,” said Dr. Jo Chien, Professor of
Medicine at UCSF and PI of the sub study. “Finding better options
for patients with HR+ tumors that have high clinical risk and
biology that does not respond well to chemotherapy and
immunotherapy is an unmet need in the field. This study is
addressing this need by exploring the potential of (Z)-endoxifen
combined with abemaciclib in the pre-operative setting.”
Under the terms of the study agreement, QLHC will conduct the
study with Atossa. Atossa and Eli Lilly and Company are 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/tissue 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 five 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/
ContactMichael Parks, VP Investor and Public
Relations 484-356-7105michael.parks@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, such as data related to the (Z)-endoxifen program, the
potential of (Z)-endoxifen as a breast cancer prevention and
treatment agent, and potential milestones and growth opportunities
for the Company, 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 remain compliant 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.
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Oct 2024 to Nov 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Nov 2023 to Nov 2024