Atossa Therapeutics Announces Updated Protocol for Clinical Trial Evaluating (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer
28 June 2024 - 10:30PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) today announced protocol changes in the previously
initiated study to evaluate Atossa’s proprietary (Z)-endoxifen in
combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase
(CDK) 4/6 inhibitor marketed by Eli Lilly and Company. The study is
investigating the combination as a neoadjuvant treatment in 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 areas of significant unmet medical need in
oncology with a focus on breast cancer.
Based on accumulating data from the ongoing Phase 2 EVANGELINE
study, the dose of (Z)-endoxifen in the combination study has been
increased from 40 mg to 80 mg once daily. The change in study dose
was determined following a review of safety, efficacy and
pharmacokinetic (PK) data from participants currently enrolled in
the 80 mg PK run-in cohort of the EVANGELINE study.
The EVANGELINE study is enrolling premenopausal women with
ER+/HER2- breast cancer. The study began with a 40 mg
pharmacokinetic (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. Efficacy was measured by both reduction in Ki-67, a
cellular marker for proliferation that indicates how fast the tumor
is growing, and response (tumor shrinkage). 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%. The study is
now enrolling an 80 mg PK cohort, which is expected to deliver the
optimal drug concentrations required to fully target PKCβ1
inhibition and further enhance (Z)-endoxifen’s antitumor
efficacy.
Additionally, the combination study will now enroll
approximately 80 participants across two 40-participant cohorts.
Both cohorts will include pre-and-menopausal women who will receive
80 mg (Z)-endoxifen once daily in combination with 150 mg
abemaciclib twice daily for up to 24-weeks prior to surgery.
Premenopausal women in the second cohort will also receive ovarian
function suppression (OFS).
Increasing the number of study participants was done to ensure a
statistically significant number of menopausal and premenopausal
women are enrolled in each cohort. The addition of OFS in
premenopausal women enrolled in the second cohort of the study will
allow for a direct comparison of safety and efficacy among the two
treatment groups. This data is expected to further validate the
growing body of evidence that (Z)-endoxifen is safe and highly
efficacious in premenopausal women without the need for OFS.
“We are extremely excited about the updated combination study
protocol and grateful for the significantly expanded support from
Eli Lilly to run the trial,” said Steven Quay, M.D., Ph.D.,
Atossa’s President and Chief Executive Officer. “As we expected,
and the preliminary EVANGELINE data has confirmed, the 80 mg dose
of (Z)-endoxifen has a highly favorable safety profile and delivers
the desired concentration levels to optimally target PKCβ1. We also
know from both the 40 mg and 80 mg EVANGELINE cohorts that
premenopausal women treated with (Z)-endoxifen experience profound
clinical benefit without the need for ovarian suppression. Further
validating this with a head-to-head comparison of data from the two
cohorts in the combination study will be extremely valuable as we
continue conversations with prospective partners and
regulators.”
Under the terms of the study agreement, 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 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: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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