Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
breast and prostate cancer, today announced that it has entered
into a clinical trial collaboration and supply agreement with Eli
Lilly and Company. The objective of the collaboration is to
evaluate the efficacy and safety of enobosarm, Veru’s oral,
first-in-class, new chemical entity, selective androgen receptor
targeting agonist that activates the androgen receptor (AR), a
tumor suppressor, in combination with Lilly’s Verzenio®
(abemaciclib), a CDK4/6 inhibitor, as a second line therapy in the
treatment of AR+ER+HER2- metastatic breast cancer.
“Independently conducted proof of concept preclinical studies in
human breast cancer models have demonstrated that the combination
of enobosarm with a CDK4/6 inhibitor had greater antitumor
synergistic activity in tumor samples from patients who had breast
cancer progression following treatment with palbociclib, a CDK4/6
inhibitor, and an estrogen blocking agent. The ENABLAR-2 trial will
evaluate the efficacy and safety of the enobosarm and abemaciclib
combination in patients that have previously received first line
therapy of palbociclib and estrogen blocking agent combination in
AR+ER+HER2- metastatic breast cancer,” said Mitchell Steiner, M.D.,
Chairman, President and Chief Executive Officer of Veru Inc. “We
are excited about potentially being an oral 2nd line therapeutic
option in combination with abemaciclib for patients who have
AR+ER+HER2- metastatic breast cancer. We are looking forward to our
collaboration with Lilly on the ENABLAR-2 clinical trial.”
Under the terms of the non-exclusive clinical trial
collaboration and supply agreement, Veru is responsible for
conducting the clinical trial while Lilly will supply Verzenio for
the study. Veru maintains full exclusive, global rights to
enobosarm.
Phase 3 ENABLAR-2 Trial DesignThe Phase 3
ENABLAR-2 clinical trial is an open-label, multicenter, randomized,
active control pivotal study evaluating the efficacy and safety of
enobosarm 9mg oral daily dosing in combination with Verzenio®, a
CDK4/6 inhibitor, versus active control (alternative estrogen
blocking agent) in the 2nd line treatment of 186 metastatic AR+ ER+
HER2- breast cancer patients who had previously received an
estrogen blocking agent in combination with palbociclib. Enobosarm
is being targeted to patients who have androgen receptor staining
levels ≥ 40% in their breast cancer tissue samples. The primary
efficacy endpoint is median radiographic progression free survival.
Secondary endpoints include overall response rate (CR+PR), change
in short physical performance battery (SPPB), and change in
DEXA-body composition muscle and bone. The Phase 3 ENABLAR-2 study
will be conducted in approximately 35 clinical sites across the
United States.
About EnobosarmEnobosarm is an oral,
first-in-class, new chemical entity that is a member of a new class
of endocrine drugs called selective androgen receptor targeting
agonists, which means it is both an agonist and an antagonist
depending on the tissue type. Enobosarm binds to the AR in breast
tissue and inhibits AR+ ER+ breast cancer cell proliferation and
tumor growth in animal models. Unlike testosterone, enobosarm
cannot be aromatized to estrogen. Enobosarm has selective clinical
properties that could have potential benefit in women with AR+ ER+
HER2- breast cancer. Preclinical studies have shown that enobosarm
builds and heals cortical and trabecular bone with the potential to
treat osteoporosis and skeletal related cancer events. Enobosarm
has been shown to build muscle and improve physical function as
well as reduce fat in clinical studies involving elderly subjects
and patients with cancer cachexia including breast cancer.
Furthermore, clinical studies have shown that the tissue
selectivity of enobosarm results in a favorable side effect profile
with no masculinizing adverse effects (facial hair and acne), no
increase in hematocrit and thrombosis, and no liver toxicity.
Enobosarm has extensive nonclinical and clinical experience, having
been evaluated in 25 separate clinical studies in approximately
1,450 subjects dosed, including three Phase 2 clinical studies in
advanced AR+ ER+ HER2- metastatic breast cancer involving more than
250 patients.
In the two Phase 2 clinical studies conducted in women with AR+
ER+ HER2- metastatic breast cancer, enobosarm demonstrated
clinically significant objective tumor responses, improvement in
quality of life, and favorable safety profile in a heavily
pretreated population of women with AR+ER-HER2- metastatic breast
cancer. Higher % AR nuclei staining in breast cancer tissue
correlated with a greater antitumor activity. By targeting and
activating AR in breast cancer tumors with sufficient AR expression
(≥40% AR nuclei staining), women with metastatic breast cancer may
be identified who are most likely to respond to enobosarm therapy.
Consequently, Veru is developing a companion diagnostic to
determine a patient’s androgen receptor expression status, and has
partnered with Roche/Ventana Diagnostics, a world leader in
oncology companion diagnostics, which will develop and, if it is
approved, commercialize the companion AR diagnostic.
Overall, these studies of enobosarm clearly establish the
clinical relevance of targeting the AR with a selective AR agonist.
Enobosarm introduces a novel endocrine therapy to patients with
breast cancer that have exhausted endocrine therapies targeting ER,
but prior to IV chemotherapy.
About Verzenio®
(abemaciclib)Verzenio® abemaciclib is a targeted
treatment known as a CDK4/6 inhibitor. Verzenio is a
non-chemotherapy oral tablet. Verzenio works inside the cell to
block CDK4/6 activity and help stop the growth of cancer cells, so
they may eventually die (based on preclinical studies).
Cyclin-dependent kinases (CDK)4/6 are activated by binding to
D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell
lines, cyclin D1 and CDK4/6 promote phosphorylation of the
retinoblastoma protein (Rb), cell cycle progression, and cell
proliferation. In vitro, continuous exposure to Verzenio inhibited
Rb phosphorylation and blocked progression from G1 to S phase of
the cell cycle, resulting in senescence and apoptosis (cell death).
Preclinically, Verzenio dosed daily without interruption resulted
in reduction of tumor size. Inhibiting CDK4/6 in healthy cells can
result in side effects, some of which may be serious. Clinical
evidence also suggests that Verzenio crosses the blood-brain
barrier. In patients with advanced cancer, including breast cancer,
concentrations of Verzenio and its active metabolites (M2 and M20)
in cerebrospinal fluid are comparable to unbound plasma
concentrations. Verzenio is Lilly's first solid oral dosage form to
be made using a faster, more efficient process known as continuous
manufacturing. Continuous manufacturing is a new and advanced type
of manufacturing within the pharmaceutical industry, and Lilly is
one of the first companies to use this technology.
About Veru Inc.Veru is an oncology
biopharmaceutical company with a principal focus on developing
novel medicines for the management of breast and prostate
cancers.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin, a cytoskeleton disruptor.
Current studies on the two drugs include:
- Enrolling Phase 3 ARTEST study of enobosarm in androgen
receptor positive, estrogen receptor positive, and human epidermal
growth factor receptor two negative (AR+ ER+ HER2-) metastatic
breast cancer with AR ≥ 40% (third-line metastatic setting), and
which has been granted Fast Track designation by the FDA.
- Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm +
abemaciclib (a CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic
breast cancer with AR ≥ 40% (second-line metastatic setting). The
Company has entered into a clinical trial collaboration and supply
agreement with Lilly regarding Lilly’s supply of Verzenio
(abemaciclib) in connection with the ENABLAR-2 trial.
- Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% (third-line metastatic
setting).
The Company has determined that patients who have ≥ 40% androgen
receptor nuclei staining by immunohistochemistry in their breast
cancer tissue, a measure of AR expression, are most likely to
respond to enobosarm. Consequently, Veru is developing a companion
diagnostic to determine a patient’s androgen receptor expression
status, and has partnered with Roche/Ventana Diagnostics, a world
leader in oncology companion diagnostics, which will develop and,
if it is approved, commercialize the companion AR diagnostic.
Veru’s late-stage prostate cancer portfolio comprises
sabizabulin, VERU-100, a long-acting GnRH antagonist, and
zuclomiphene citrate, an oral nonsteroidal estrogen receptor
agonist.
Current studies on these drugs include:
- Enrolling Phase 3 VERACITY and ongoing Phase 2 studies of
sabizabulin in metastatic castration and androgen receptor
targeting agent resistant prostate cancer prior to IV
chemotherapy.
- Enrolling Phase 2 dose-finding study of VERU-100 in advanced
hormone-sensitive prostate cancer.
- Planned Phase 2b study of zuclomiphene citrate in men with
advanced prostate cancer undergoing androgen deprivation therapy
who suffer from hot flashes.
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, is currently enrolling in a Phase 3
study for the treatment of hospitalized COVID-19 patients at high
risk for acute respiratory distress syndrome, also known as the
cytokine storm, and which has been granted Fast Track designation
by the FDA.
Veru also has a commercial sexual health division, the proceeds
of which help fund its drug development programs, comprised of:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia, for which
commercialization launch plans are underway.
- FC2 Female Condom® (internal condom), for the dual protection
against unplanned pregnancy and the transmission of sexually
transmitted infections which is sold in the U.S. and globally.
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 regarding: the expected commencement
timing of the Phase 3 ENABLAR-2 study; whether enobosarm in
combination with abemaciclib will demonstrate sufficient safety and
efficacy to ever be approved by the FDA or any other regulatory as
an oral 2nd line therapeutic option for patients who have
AR+ER+HER2- metastatic breast cancer; whether and when enobosarm
will be approved by FDA for the treatment of any other breast
cancers and the timing of the Company’s submissions to FDA and
FDA’s review of such submissions; whether any of the selective
clinical properties previously observed in clinical studies of
enobosarm will be replicated in the current and planned clinical
development program for enobosarm and whether any such properties
will be recognized by the FDA in any potential approvals and
labeling; 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 and
companion diagnostic, the anticipated design and scope for clinical
trials and FDA acceptance of such design and scope, whether any
accelerated regulatory pathways, including Fast Track designation,
to secure FDA approval for sabizabulin, enobosarm or any of the
Company’s drug candidates are available, when clinical results from
the ongoing sabizabulin COVID-19 Phase 3 trial will be available,
whether sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI
will serve any unmet need, what dosage, if any, might be approved
for use in the US or elsewhere, and whether the commencement or
enrollment timelines for the clinical trials and development of the
companion diagnostic will be met, and also statements about the
potential, timing and efficacy of the rest of the Company’s
development pipeline, including the ability of the Company to
successfully launch ENTADFI, whether and when enobosarm will be
approved by FDA for the treatment of certain breast cancers and the
timing of the Company’s submissions to FDA and FDA’s review of such
submissions; whether any of the selective clinical properties
previously observed in clinical studies of sabizabulin, enobosarm
or other drug candidates will be replicated in the current and
planned clinical development program for such drug candidate and
whether any such properties will be recognized by the FDA in any
potential approvals and labeling; when commercial launch of ENTADFI
will occur; the magnitude of any potential revenues generated by
ENTADFI; whether the Company’s current or future clinical
development program results will demonstrate sufficient efficacy
and safety and potential benefits to secure FDA approval of the
Company’s drug candidates; and whether the companion diagnostic for
enobosarm will be developed successfully or be approved by the FDA
for use. 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;
including the risk of a delay or failure in reaching agreement with
the FDA on the design of a clinical trial or in obtaining
authorization to commence a clinical trial or commercialize a
product candidate in the U.S.; 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, 2021 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.
Verzenio® is a trademark owned by or licensed to Eli Lilly and
Company, its subsidiaries, or affiliates.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relationsand Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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