Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative medicines in areas
of significant unmet medical need in oncology, and Quantum Leap
Healthcare Collaborative™ today announce that Atossa’s proprietary
Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will
be evaluated in a new study arm of the ongoing I-SPY 2 clinical
trial. The I-SPY 2 TRIAL evaluates neoadjuvant treatments for
locally advanced breast cancer and is a collaborative effort among
academic investigators from major cancer research centers across
the United States, Quantum Leap Healthcare Collaborative, the U.S.
Food and Drug Administration, and the Foundation for the National
Institutes of Health (FNIH) Cancer Biomarkers Consortium.
Approximately 20 patients will be treated with (Z)-endoxifen for up
to 24 weeks prior to surgery.
The new study arm evaluating (Z)-endoxifen 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 agents that are more tolerable and effective than the current
standard of care and address the risk of recurrence.
“Atossa is proud to partner with Quantum Leap Healthcare
Collaborative and excited that (Z)-endoxifen has been added to
their unprecedented I-SPY clinical trial, which is designed to
quickly and efficiently bring new drug therapies to breast cancer
patients who need them urgently,” said Dr. Steven Quay, Atossa’s
President and Chief Executive Officer. “Data from this trial will
supplement data generated through our ongoing Phase 2 EVANGELINE
trial, which is investigating (Z)-endoxifen as a neoadjuvant
treatment for premenopausal women with ER+ / HER2- breast cancer.
There remains a critical need for more effective and tolerable
treatment options for this patient population.”
“(Z)-endoxifen is one of the most active metabolites of
tamoxifen. Tamoxifen is known to be effective in treating and
preventing ER+ breast cancer, but may be most effective in those
patients who can adequately metabolize it,” said Dr. Laura Esserman
of the University of California San Francisco, founder and leader
of the I-SPY TRIAL. “(Z)-endoxifen may overcome some of the
shortcomings of tamoxifen, as it is already the active metabolite.
Perhaps most exciting is that it may be effective in premenopausal
women without the need for ovarian suppression. Ovarian suppression
in premenopausal women and aromatase inhibitors in postmenopausal
women are associated with both short-term and potential long-term
side effects that diminish adherence. (Z)-endoxifen holds promise
of being a more effective and tolerable alternative to targeting
the estrogen receptor in women with early-stage breast cancer.”
Atossa is currently evaluating (Z)-endoxifen in two ongoing
Phase 2 studies:
The EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) trial is
a randomized non-inferiority study of (Z)-endoxifen compared to
exemestane plus goserelin as a neoadjuvant treatment for
premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer.
Participants receive neoadjuvant treatment for up to six months,
followed by surgery. The primary objective of the EVANGELINE study
is to determine whether the endocrine sensitive disease (ESD) rate,
measured by Ki-67 (a proliferation marker prognostic for disease
free survival), after four weeks of treatment with (Z)-endoxifen is
non-inferior to the ESD rate following treatment with current
standard of care, exemestane plus goserelin. Exemestane is an
aromatase inhibitor designed to block the synthesis of estrogen and
slow the growth of ER+ cancers. Goserelin is a medication given to
block the ovaries from making estrogen, which in premenopausal
women is associated with significant morbidity and inadequate
compliance, which compromises efficacy and increases the risk of
mortality.
The Karisma-Endoxifen trial is a randomized, double-blind,
placebo-controlled efficacy study of oral (Z)-endoxifen in
premenopausal women with measurable breast density. Participants
receive daily doses of (Z)-endoxifen for six months, over the
course of which mammograms are conducted to measure reduction in
mammographic breast density (MBD). Participants also have a
mammogram at 24 months to assess the durability of the MBD changes.
MBD affects more than 10 million women in the United States and
many millions more worldwide. Increased MBD reduces the ability of
mammograms to detect cancer. Studies have also shown that women
with MBD have an increased risk of developing breast cancer and
that the higher the MBD, the higher the incidence of breast
cancer.
Atossa will supply (Z)-endoxifen and provide financial support
to Quantum Leap for this study. Quantum Leap, as sponsor, will
provide the clinical sites and clinical expertise. Currently, there
are 41 open sites, all of which have the EOP program open.
About Premenopausal Patients with ER+ / HER2- Breast
CancerBreast cancer is the most frequently diagnosed
cancer in premenopausal women worldwide and accounts for almost
half of the cancers that occur in women aged 15-49. An overwhelming
majority (75%) of premenopausal breast cancer falls under luminal A
(ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function
suppression, when combined with either tamoxifen or an aromatase
inhibitor, is the standard of care for the endocrine management of
stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY
Endocrine Optimization Pilot (EOP) specifically targets women of
all ages with molecularly low risk stage 2 and 3 breast cancer.
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 anti-estrogenic 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 has developed 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 converts 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 our (Z)-endoxifen in healthy women with measurable breast
density and premenopausal women with ER+/HER2- breast cancer.
Atossa’s (Z)-endoxifen is protected by two 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 current focus on breast cancer and lung injury
caused by cancer treatments. 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 Contacts:Kyle GuseGeneral
Counsel and Chief Financial Officerkyle.guse@atossainc.com
Eric 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 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.
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