Atossa Therapeutics and Quantum Leap Healthcare Provide Enrollment Update for (Z)-Endoxifen Arm of Ongoing I-SPY 2 Clinical Trial
June 28 2023 - 9:15AM
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 treatment 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 will 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
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 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 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 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 Contact: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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