SEATTLE and SAN
FRANCISCO, June 28, 2023 /PRNewswire/ -- Atossa
Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative medicines in areas
of significant unmet medical need in oncology with a focus on
breast cancer, and Quantum Leap Healthcare Collaborative™ ("Quantum
Leap") today announced that six patients have been dosed with
Atossa's proprietary Selective Estrogen Receptor Modulator (SERM),
(Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial.
(Z)-endoxifen is being evaluated as a neoadjuvant treatment for
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.
The I-SPY 2 TRIAL 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. The (Z)-endoxifen treatment arm,
which is expected to enroll approximately 20 patients, is part of
the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). Patients
will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior
to surgery. Currently, there are 41 I-SPY 2 sites, all of which
have the EOP program open.
"Reaching 30% enrollment in the I-SPY 2 study is another
important milestone in our ambitious (Z)-endoxifen development
program," said Dr. Steven Quay,
Atossa's President and Chief Executive Officer. "These patients
have substantial risk for recurrence and need novel treatments
options that are more tolerable and more efficacious than currently
approved drugs. (Z)-endoxifen has the potential to slow the
progression of ER-positive breast cancer in the neoadjuvant
setting, making surgery more effective and reducing the risk of
recurrence. We look forward to seeing data from this trial, which
along with data from our Phase 2 EVANGELINE trial, will inform
conversations with the FDA and our planned Phase 3 protocol."
"With the ISPY 2.2 TRIAL, we have focused on optimizing
treatments for the fast-growing breast cancers; that focus has
allowed us to make great progress. But one of the biggest
challenges in breast cancer is the hormone positive breast cancers
that are slow growing. They can recur for up to 15 years or more,
and we urgently need to find predictors of response so that we can
prevent late recurrence. And we know that women suffer from the
side effects of years of extended endocrine therapy, especially
when they have larger tumors. So, we have a great need to find more
effective and more tolerable agents so that women with live longer
and better. The goal of the endocrine optimization pilot is to test
these new and exciting hormone directed therapies like
endoxifen," said Dr. Laura
Esserman of the University of
California San Francisco, founder and leader of the I-SPY
TRIAL.
About Premenopausal Patients with ER+ / HER2- Breast
Cancer
Breast 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 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.
The Company is 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 Therapeutics
Atossa 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
About Quantum Leap Healthcare Collaborative
Quantum
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 TRIALs
The 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.
FORWARD LOOKING STATEMENTS
Forward-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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-and-quantum-leap-healthcare-provide-enrollment-update-for-z-endoxifen-arm-of-ongoing-i-spy-2-clinical-trial-301865328.html
SOURCE Quantum Leap Healthcare Collaborative