Atossa Therapeutics Completes Enrollment of 80mg Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer
22 July 2024 - 10:30PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) today announced that the 12-patient 80mg pharmacokinetic
(PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus
exemestANe GosEreLIn) study has fully enrolled. EVANGELINE is a
randomized non-inferiority trial of Atossa’s patented Selective
Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane
plus goserelin as a neoadjuvant treatment for pre-menopausal women
with Grade 1 or 2 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 areas of significant unmet medical need in
oncology with a focus on breast cancer.
The 80mg PK run-in cohort consists of 12 pre-menopausal women,
all of whom will be treated with (Z)-endoxifen at 80mg/day for four
weeks. After four weeks of treatment, participants with Ki-67
levels below 10% will continue on study drug for five additional
months, followed by surgery. Ki-67 is a cellular marker for
proliferation that indicates how fast the tumor is growing. Once
the optimal dose of (Z)-endoxifen is determined, the treatment
cohort will commence. The study is expected to enroll approximately
175 patients at up to 25 sites across the United States.
The EVANGELINE study began with a 40mg PK run-in cohort. Data
from this cohort, which was presented at the 2024 American
Association for Cancer Research (AACR) Annual Meeting, showed
encouraging efficacy and an extremely favorable safety profile
compared to currently approved endocrine therapies. Participants
treated for a total of 24-weeks experienced an average reduction in
Ki-67 of 92% and an average target lesion decrease of 37%. MRI
central review at week 12 and week 24 demonstrated tumor shrinkage
in all patients with one complete response, one partial response
and four cases of stable disease. The 80mg dose is expected to
deliver the optimal drug concentrations required to fully target
PKCβ1 inhibition and further enhance (Z)-endoxifen’s antitumor
efficacy.
“Full enrollment of the 80mg pharmacokinetic run-in cohort of
the EVANGELINE study is yet another important milestone in our
ambitious (Z)-endoxifen development program,” said Steven Quay,
M.D., Ph.D., Atossa’s President and Chief Executive Officer. “Based
on data from the 40mg cohort and a review of safety, efficacy and
PK data from participants enrolled earlier in the 80mg PK run-in
cohort, we are confident that the 80mg dose will be well tolerated
and deliver the optimal concentration levels to fully target PKCβ1
inhibition. We look forward to opening the treatment arm of this
important study and bringing this potentially transformative
treatment to women diagnosed with breast cancer as quickly as
possible.”
About the Phase 2 EVANGELINE StudyThe Phase 2
EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study is a
randomized non-inferiority trial of Atossa’s patented Selective
Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane
plus goserelin as a neoadjuvant treatment for pre-menopausal women
with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human
Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
The primary objective of the EVANGELINE study is to evaluate 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 compared to 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,
also called ovarian function suppression (OFS). In premenopausal
women, OFS is associated with significant morbidity and inadequate
compliance, which compromises efficacy and increases the risk of
mortality.
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.
Contact:Heather ReesChief Financial
Officerheather.rees@atossainc.com
Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
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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