Veru Inc.’s Oncology Drug Research Program Partner, The University of Tennessee Health Science Center, Awarded Two New Federal Grants
June 21 2023 - 8:30AM
The University of Tennessee Health Science Center (UTHSC), oncology
drug discovery research partner to Veru Inc. (NASDAQ: VERU), a late
clinical stage biopharmaceutical company focused on developing
novel medicines for the treatment of breast cancer and for
SARS-CoV-2 and other viral ARDS-related diseases, has secured two
additional grants to develop oncology therapeutics for indications
of high unmet need. UTHSC was awarded $924,000 from the U.S.
Department of Defense (DoD) and $3,074,470 from the National Cancer
Institute’s Research Project Grant (NCI R01). These two new grants
awarded to UTHSC bring the university’s aggregate oncology funding
related to this project to over $10 million.
Through the Company’s collaboration with UTHSC, leveraging its
existing sponsored research agreement and its private-public
partnership and other arrangements with UTHSC, Veru holds the
opportunity to continue to develop and to potentially commercialize
oncology agents developed by this research which include:
- Targeting drugs, including conjugated drugs for metastatic
prostate cancer and for drug-resistant hormone receptor positive
HER2- metastatic breast cancer as well as brain and bone metastases
from breast cancer
- Novel targeting drugs for drug resistant advanced ovarian
cancer
The research conducted at UTHSC is led by Dr. Wei Li, Ph.D.,
Principal Investigator and Distinguished Professor of
Pharmaceutical Sciences and Director of the Drug Discovery Center
in the College of Pharmacy, and includes Dr. Duane D. Miller,
Ph.D., Professor Emeritus of Pharmaceutical Sciences, Dr. Tiffany
N. Seagroves, Ph.D., Professor of Pathology in the College of
Medicine, and Dr. Junming Yue, Ph.D., associate professor of
Pathology in the College of Medicine.
“We are pleased with our longstanding research collaboration
with the University of Tennessee Health Science Center
investigating new compounds for oncology, which has garnered
additional DoD and NCI funding for new research projects,” said
Mitchell Steiner, M.D., Chairman, President, and Chief Executive
Officer of Veru. “Dr. Wei Li and Dr. Duane Miller’s research labs
have demonstrated a track record of discovering important agents in
advanced cancers. Furthermore, we are particularly excited about
the expansion of their research into targeting cancer using drug
conjugates, which may increase efficacy of these drugs with fewer
unwanted side effects. Validation of this research approach is
reflected in peer-reviewed support from the U.S. government in the
form of two awarded grants. We are confident our public-private
partnership with UTHSC will continue to flourish and potentially
lead to Veru clinical programs in the coming years.”
“A core research principle at UTHSC is to develop new
therapeutics that can overcome existing clinical challenges in
cancer indications,” said Dr. Wei Li, Ph.D., Principal Investigator
and UTHSC Distinguished Professor of Pharmaceutical Sciences and
Director of the Drug Discovery Center. “We are very excited to
receive significant federal grants that enable us to advance our
research in metastatic prostate cancer, metastatic breast cancer
and drug-resistant ovarian cancer. We are committed to
collaborating with our clinical partner, Veru, who may ultimately
pursue for late-stage clinical drug development.”
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
the treatment of breast cancer and for SARS-CoV-2 and other viral
ARDS-related diseases.
Oncology program focuses on breast cancer
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist.
- Enrolling Phase 2b/3 ENABLAR-2 study of enobosarm + abemaciclib
(a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic
breast cancer (second-line metastatic setting). The Company and Eli
Lilly and Company have entered into a clinical study collaboration
and supply agreement for the ENABLAR-2 study. Lilly will supply
Verzenio® (abemaciclib).
- Planned Phase 2b/3 study of enobosarm in nonmeasurable bone
only metastatic breast cancer.
Infectious disease program focuses
viral acute respiratory distress syndrome caused by SARS-CoV-2,
Influenza, and RSV as well as viruses that pose serious worldwide
global threat
- COVID-19: Sabizabulin is an
oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and host mediated antiviral
properties. Veru has conducted a positive double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial in 204
hospitalized moderate to severe COVID-19 patients at high risk for
ARDS and death. The primary endpoint was the proportion of deaths
by Day 60. Treatment with sabizabulin resulted in a clinically
meaningful and statistically significant 51.6% relative reduction
in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track
designation to the Company’s COVID-19 program in January
2022. In April 2023, the Company reached agreement with FDA on
design of Phase 3 confirmatory COVID-19 clinical trial to evaluate
sabizabulin in hospitalized moderate to severe COVID-19 patients at
high risk for ARDS. The Company plans to initiate this Phase 3
clinical study in 2H 2023.
- Influenza: The Company is planning a Phase 3
clinical trial to evaluate sabizabulin in hospitalized influenza
patients at high risk for ARDS.
- Smallpox and Ebola viruses: The Company is
planning a pre-IND meeting with FDA to discuss the development of
sabizabulin for smallpox virus and Ebola virus under the Animal
Rule FDA regulatory approval pathway.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is
comprised of:
- 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: whether the development by
UTHSC will produce any compounds that Veru will choose to further
develop and whether any such further development will lead to any
approval or commercialization of any such compound potentially
deriving from the research collaboration between UTHSC and Veru;
what indications, if any, such UTHSC research may focus on or
produce meaningful results in; the planned design, enrollment,
timing, commencement, interim and full data readout timing, scope,
regulatory pathways, and results of the Company’s current and
planned clinical trials, including the confirmatory Phase 3 study
of sabizabulin for certain COVID-19 patients, the Phase 2b/3 study
of enobosarm in combination with abemaciclib for the 2nd line
treatment of AR+ ER+ HER2 metastatic breast cancer, the Phase 2b/3
study of enobosarm in bone-only non-measurable hormone receptor and
HER2- metastatic breast cancer, the Phase 3 study of sabizabulin in
hospitalized influenza patients at high risk of ARDS, and studies
of sabizabulin in smallpox virus and Ebola virus, and whether any
of such studies will meet any of its primary or secondary endpoint;
whether and when any of the planned interim analyses in the planned
Phase 3 confirmatory study of sabizabulin for certain COVID
patients will occur and what the results of any such interim
analyses will be; whether the results of such interim analyses or
the completed confirmatory Phase 3 study or any other interim data
will be sufficient to support a new EUA application or an NDA;
whether and when any potential EUA or NDA would be grated; whether
and when the Company will meet with BARDA regarding any potential
partnering opportunities and whether those efforts will be
successful; whether and how the Company will fund the planned Phase
3 studies of sabizabulin in influenza, pox virus and COVID-19;
whether and when the Company will expand the study of sabizabulin
into other ARDS indications; whether the current and future
clinical development efforts of the Company, including all studies
of sabizabulin in infectious disease indications and enobosarm in
oncology indications, and any of their results will demonstrate
sufficient efficacy and safety and potential benefits to secure FDA
approval of any of the Company’s drug candidates; whether the drug
candidates will be approved for the targeted line of therapy;
whether sabizabulin will become a treatment for broad ARDS; whether
the Company’s FC2 telemedicine portal sales will grow or replace
prior revenue from the U.S. prescription sales of FC2; whether the
Company will recover any of the monies owed it by The Pill Club;
whether and when the Company will receive the remaining
installments from Blue Water in connection with the sale of ENTADFI
or will receive any of the potential sales milestones related
thereto; whether, when and how many shares may be sold under the
Lincoln Park Capital Fund equity line; and whether the Company’s
current cash will be sufficient to fund its planned or expected
operations. 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 studies possibly being unsuccessful or insufficient to
meet applicable regulatory standards or warrant continued
development; the ability to enroll sufficient numbers of subjects
in clinical studies and the ability to enroll subjects in
accordance with planned schedules; the ability to fund planned
clinical development as well as other operations of the Company;
the timing of any submission to the FDA or any other regulatory
authority and any determinations made by the FDA or any other
regulatory authority; the possibility that as vaccines, anti-virals
and other treatments 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, including FC2 and
ENTADFI and, if authorized, sabizabulin, 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 studies, 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; risks relating to the Company's
development of its own dedicated direct to patient telemedicine and
telepharmacy services platform, including the Company's lack of
experience in developing such a platform, potential regulatory
complexity, and development costs; 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 and securities litigation; 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, 2022 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.
Investor Contact: Samuel FischExecutive Director, Investor
Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Media Contact:Hannah GendelManager, Corporate
CommunicationsEmail: media@verupharma.com
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