Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
prostate and breast cancer, today announced additional clinical
results from the Phase 2 study demonstrating that the anticancer
benefits of enobosarm, a selective androgen receptor (AR) targeting
agent, were related to the presence and amount of AR expression in
breast cancer tissue in subjects with AR+ER+ HER2- metastatic
breast cancer, will be presented at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8,
2021.
Highlights of presentation:
In preclinical studies, AR has been established as a tumor
suppressor in breast cancer. Clinically, AR is expressed in up to
90% of breast cancers and targeting AR with enobosarm, an oral
selective AR agonist, would be a major new endocrine therapy for
metastatic breast cancer. The positive G200802 Phase 2 clinical
study in 136 heavily pretreated women with AR+ER+HER2- metastatic
breast cancer who progressed following CDK4/6 inhibitor and/or
estrogen blocking agent treatment confirmed that the AR is commonly
expressed in breast cancer tissue (86.5-94%) and when activated by
enobosarm is acting in these patients as a tumor suppressor.
In the overall Phase 2 study, the presence and the amount of AR
receptor expression in breast cancer tissue correlated with a
beneficial antitumor response. The best overall target lesion
reduction of >30% occurred only in subjects who were AR+. In a
post-hoc analysis of 84 women who had AR+ER+HER2- metastatic breast
cancer, measurable disease, and centrally confirmed AR status at
study entry, an AR positivity threshold of ≥ 40% in breast cancer
tissue distinguished patients that responded to enobosarm in both
dose arms (9 and 18 mg). AR positivity ≥ 40% was common as 52% of
subjects in study met this threshold.
Focusing on the 9mg cohort, the dose selected for the Phase 3
ARTEST study, the best objective tumor response rate (complete +
partial responses) was 48% for ≥ 40% AR positivity versus 0% for
<40% AR positivity (p<0.0001). Similarly, the clinical
benefit rate was 79% for ≥ 40% AR positivity versus 18% for <40%
AR positivity (p<0.0001). The median radiographic progression
free survival was 5.5 month for ≥ 40% AR positivity versus 2.75
months for <40% AR positivity (p<0.001). Enobosarm was very
well tolerated without masculinizing side effects, increases in
hematocrit, or liver toxicity.
Conclusions from Phase 2 study:
- Enobosarm, a selective AR agonist, targets AR, a tumor
suppressor, in AR+ ER+ HER2- metastatic breast cancer
- Objective tumor responses (efficacy) to enobosarm monotherapy
require the presence and a threshold level of AR expression (≥40%
AR cutoff) in heavily pretreated AR+ ER+ HER2- metastatic breast
cancer
- AR may be used as a biomarker to identify patients with AR+ ER+
HER2- metastatic breast cancer that are most likely to respond to
enobosarm
- Enobosarm treatment was well tolerated as an endocrine therapy
without masculinizing side effects, increases in hematocrit, or
liver toxicity
- Targeting the AR tumor suppressor pathway to be studied
prospectively in a 3rd line metastatic setting in the Phase 3
ARTEST registration clinical trial of enobosarm monotherapy versus
active control (exemestane everolimus or a SERM) for the treatment
of AR+ER+HER2- metastatic breast cancer patients who have
failed a nonsteroidal aromatase inhibitor, fulvestrant, and a
CDK4/6 inhibitor.
“There is an urgent need for new therapies for patients whose
metastatic breast cancer disease progresses following treatment
with ER directed endocrine therapy and CDK 4/6 inhibitor. This
current exploratory analysis from the Phase 2 study of enobosarm
demonstrates that the amount of AR expressed may be important in
defining patients who are most likely to have an antitumor response
to enobosarm, an oral selective AR agonist. Furthermore, enobosarm
had positive effects on quality of life and was well tolerated.
These key Phase 2 clinical findings will be tested in the Phase 3
ARTEST clinical study, which is comparing enobosarm to physician’s
choice of endocrine therapy in patients progressing following a
CDK4/6 inhibitor and if positive would open up a new treatment
option for women with ER+AR+ metastatic breast cancer,” said
Professor Carlo Palmieri, BSc, MB BS, PhD, FRCP, Professor of
Translational Oncology & Medical Oncologist, University of
Liverpool and lead presenter for this study.“We have transformed
our company into a late clinical stage oncology company. The
enobosarm breast cancer clinical development program is growing and
is led by the Phase 3 ARTEST clinical trial of enobosarm
monotherapy in the 3rd line metastatic setting in subjects with
AR+ER+HER2- metastatic breast cancer which is expected to begin
enrolling in the third quarter of this year,” said Dr. Mitchell
Steiner, Chairman, President and CEO of Veru Inc. “We are also
advancing enobosarm into a Phase 2 clinical study, in the 2nd line
metastatic setting, to evaluate the combination of enobosarm and
abemaciclib in AR+ER+HER2- metastatic breast cancer patients who
progressed following treatment with palbociclib, a CDK4/6
inhibitor, in combination with an estrogen blocking agent. This is
also a large market and unmet medical need. We expect the Phase 2
to commence in calendar Q3 2021.”
Enobosarm Clinical Development ProgramEnobosarm
is an oral, first-in-class, new chemical entity, selective androgen
receptor targeting agonist that activates the androgen receptor, a
tumor suppressor, in AR+ER+HER2- metastatic breast cancer. The
enobosarm clinical development program is initially focusing on two
indications: (1) Phase 3 ARTEST clinical study of enobosarm in the
3rd line metastatic setting for AR+ER+HER2- metastatic breast
cancer patients (≥ 40% AR positivity) whose disease has progressed
after treatment with a nonsteroidal aromatase inhibitor,
fulvestrant, and a CDK4/6 inhibitor which is expected to begin
enrollment calendar third quarter 2021; (2) Phase 2 clinical study
of enobosarm + CDK4/6 inhibitor, abemaciclib, in the 2nd line
metastatic setting for AR+ER+HER2- metastatic breast cancer
patients (≥ 40% AR positivity) whose disease has progressed after
treatment with a 1st line CDK 4/6 inhibitor, palbociclib, in
combination with either a nonsteroidal aromatase inhibitor or
fulvestrant which is expected to begin enrollment during the third
quarter of calendar 2021.
About the Enobosarm Phase 2 Clinical TrialThe
Phase 2 clinical study (G200802) was an international, open label,
parallel design, randomized study to investigate the efficacy and
safety of enobosarm 9mg and 18mg oral daily dosing in 136 heavily
pretreated women with ER+HER2- metastatic breast cancer who had
breast cancer progression being treated with multiple lines of
endocrine therapy including CDK 4/6 inhibitors and 90% who had also
failed chemotherapy. Patients were randomized to receive enobosarm
9mg (n=72) or 18mg (n=64) oral daily dosing. The primary endpoint
was clinical benefit rate at 24 weeks determined by RECIST 1.1.
Secondary endpoints included objective response rate, best overall
response rate, radiographic progression-free survival, and duration
of clinical benefit. About Veru Inc.Veru Inc. is
an oncology biopharmaceutical company with a focus on developing
novel medicines for the management of prostate cancer and breast
cancer. Veru’s prostate cancer pipeline includes: sabizabulin, an
oral, first-in-class, new chemical entity that targets the
cytoskeleton disruptor which in prostate cancer also disrupts
androgen receptor transport. A Phase 3 VERACITY clinical trial
evaluating the efficacy and safety of sabizabulin in approximately
245 men for the treatment of metastatic castration and androgen
receptor targeting agent resistant prostate cancer is expected to
commence in June. VERU-100, a novel, proprietary gonadotropin
releasing hormone antagonist peptide long acting 3-month
subcutaneous injection formulation for androgen deprivation
therapy, is expected to start the planned Phase 2 clinical study
later this month, and the Phase 3 clinical study is planned to
initiate in calendar Q4 2021 to treat hormone sensitive metastatic
prostate cancer. Veru’s breast cancer pipeline includes: enobosarm,
an oral, first-in-class, new chemical entity, selective androgen
receptor agonist that targets the androgen receptor, a tumor
suppressor, to treat AR+ER+HER2- metastatic breast cancer without
unwanted masculinizing side effect enobosarm clinical program is
initially focusing on 2 indications. 1) Phase 3 ARTEST clinical
trial to evaluate enobosarm monotherapy in a 3rd line metastatic
setting in approximately 210 subjects with AR+ER+HER2- metastatic
breast cancer (≥ 40% AR positivity) who have failed nonsteroidal
aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor which is
anticipated to commence calendar Q3 2021. 2) Phase 2 study to
evaluate the efficacy and safety of enobosarm and CDK 4/6
inhibitor, abemaciclib, combination compared to estrogen receptor
blocking agent (Active Control) for the treatment of AR+ER+HER2-
metastatic breast cancer (≥ 40% AR positivity) in a 2nd line
metastatic setting in approximately 106 patients who have failed
1st line treatment with CDK 4/6 inhibitor, palbociclib, in
combination with either an aromatase inhibitor or fulvestrant which
is expected to commence in calendar Q3 2021. Sabizabulin is also
being evaluated in a three arm Phase 2b clinical study in calendar
Q3 2021 to evaluate oral daily dosing of sabizabulin monotherapy,
TRODELVY® monotherapy, and sabizabulin + TRODELVY combination
therapy in approximately 156 women with metastatic triple negative
breast cancer that have become resistant to at least two systemic
chemotherapies including a taxane. Based on positive Phase 2
results on the reduction of mortality, sabizabulin is also being
evaluated in a Phase 3 trial in approximately 300 subjects for the
treatment of hospitalized patients with moderate to severe COVID-19
who are at high risk for acute respiratory distress syndrome.
The Company’s Sexual Health Business commercial product is the
FC2 Female Condom® (internal condom) (“FC2”), an FDA-approved
product for dual protection against unintended pregnancy and the
transmission of sexually transmitted infections. The Company’s
Female Health Company Division markets and sells FC2 commercially
and in the public health sector both in the U.S. and globally. In
the U.S., FC2 is available by prescription through multiple
third-party telemedicine and internet pharmacy providers and retail
pharmacies. In the global public health sector, the Company markets
FC2 to entities, including ministries of health, government health
agencies, U.N. agencies, nonprofit organizations and commercial
partners, that work to support and improve the lives, health and
well-being of women around the world. The second potential
commercial product, if approved, expected for the Sexual Health
Business is TADFIN™ (tadalafil 5mg and finasteride 5mg) capsule for
the administration of tadalafil 5mg and finasteride 5mg combination
formulation dosed daily for benign prostatic hyperplasia (BPH). An
NDA was filed by FDA in April 2021 with a PDUFA date in December
2021. The Company plans to launch through telemedicine and
telepharmacy sales channels. To learn more about Veru products,
please visit www.verupharma.com.
Forward-Looking StatementsThe statements in
this release that are not historical facts are “forward-looking
statements” as that term is defined in the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this
release include statements whether future clinical development and
results will demonstrate sufficient efficacy and safety and
potential benefits to secure FDA approval of the Company’s drug
candidates, the anticipated design and scope for clinical trials
and FDA acceptance of such design and scope, whether sabizabulin,
enobosarm, VERU-100 and TADFIN will serve any unmet need, what
dosage, if any, might be approved for use in the US or elsewhere,
and whether the enrollment timelines for the clinical trials will
be met, whether and when a companion diagnostic test for AR will be
developed and used successfully for enobosarm in breast cancer, and
also statements about the potential, timing and efficacy of the
rest of the Company’s development pipeline, including whether and
when TADFIN will be approved by the FDA and the ability of the
Company to successfully launch TADFIN, if approved. These
forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: the development of the
Company’s product portfolio and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials and the
ability to enroll subjects in accordance with planned schedules;
the ability to fund planned clinical development; the timing of any
submission to the FDA and any determinations made by the FDA or any
other regulatory authority; the possibility that as vaccines become
widely distributed the need for new COVID-19 treatment candidates
may be reduced or eliminated; government entities possibly taking
actions that directly or indirectly have the effect of limiting
opportunities for sabizabulin as a COVID-19 treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 treatments; the Company’s existing products and any future
products, if approved, possibly not being commercially successful;
the effects of the COVID-19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain and other
third-party providers, commercial efforts, and business development
operations; the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations; demand for, market acceptance of, and competition
against any of the Company’s products or product candidates; new or
existing competitors with greater resources and capabilities and
new competitive product approvals and/or introductions; changes in
regulatory practices or policies or government-driven healthcare
reform efforts, including pricing pressures and insurance coverage
and reimbursement changes; the Company’s ability to successfully
commercialize any of its products, if approved; the Company’s
ability to protect and enforce its intellectual property; the
potential that delays in orders or shipments under government
tenders or the Company’s U.S. prescription business could cause
significant quarter-to-quarter variations in the Company’s
operating results and adversely affect its net revenues and gross
profit; the Company’s reliance on its international partners and on
the level of spending by country governments, global donors and
other public health organizations in the global public sector; the
concentration of accounts receivable with our largest customers and
the collection of those receivables; the Company’s production
capacity, efficiency and supply constraints and interruptions,
including potential disruption of production at the Company’s and
third party manufacturing facilities and/or of the Company’s
ability to timely supply product due to labor unrest or strikes,
labor shortages, raw material shortages, physical damage to the
Company’s and third party facilities, COVID-19 (including the
impact of COVID-19 on suppliers of key raw materials), product
testing, transportation delays or regulatory actions; costs and
other effects of litigation, including product liability claims;
the Company’s ability to identify, successfully negotiate and
complete suitable acquisitions or other strategic initiatives; the
Company’s ability to successfully integrate acquired businesses,
technologies or products; and other risks detailed from time to
time in the Company’s press releases, shareholder communications
and Securities and Exchange Commission filings, including the
Company’s Form 10-K for the fiscal year ended September 30, 2020
and subsequent quarterly reports on Form 10-Q. These documents are
available on the “SEC Filings” section of our website at
www.verupharma.com/investors. The Company disclaims any intent or
obligation to update these forward-looking statements.
Contact:Sam
Fisch 800-972-0538Director
of Investor Relations
Veru (NASDAQ:VERU)
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