RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”),
a specialty biopharmaceutical company, today announced that it has
received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for a new patent application related to
the use of two of RedHill’s proprietary investigational compounds,
opaganib (Yeliva®, ABC294640) and RHB-107 (upamostat)1, for the
treatment of solid tumor cancers. The patent is expected to extend
IP protection for the combination until 2036.
Findings from a recent pre-clinical study
evaluating the antitumor effect of opaganib and RHB-107 on
cholangiocarcinoma (also known as bile duct cancer) patient-derived
xenografts demonstrated that treatment with opaganib and RHB-107,
individually and in combination, resulted in tumor regression.
Moreover, the combination of both drugs was found to be more potent
and well tolerated in the animal models. These findings were
presented at the American Association for Cancer Research (AACR)
annual meeting earlier this year2.
“It is becoming increasingly evident that
cancers are dependent on a number of altered molecular pathways and
can develop diverse mechanisms of resistance to therapy with single
agents,” said Danielle T. Abramson, Ph.D., VP,
Intellectual Property & Research at RedHill. “This
application is part of a growing patent portfolio that expands
patent protection for our oncology program through 2036. We are
very pleased with the additional IP protection for the novel
combination of opaganib and RHB-107, which follows promising
findings on the potent synergistic antitumor activity of this
combination.”
RedHill is conducting a Phase 2a study
evaluating the activity of opaganib in advanced, unresectable
intrahepatic, perihilar and extrahepatic cholangiocarcinoma
(NCT03377179). Enrollment has been completed for the first cohort
of 39 patients, evaluating the activity of orally-administered
opaganib as a stand-alone treatment. Preliminary data from this
cohort indicated a signal of activity in a number of subjects with
advanced cholangiocarcinoma, and in light of these data, input from
key opinion leaders and preclinical research that had been
conducted at Mayo Clinic, RedHill initiated enrollment for a second
cohort, evaluating opaganib in combination with hydroxychloroquine,
an anti-autophagy agent. Given the encouraging pre-clinical data,
RedHill plans to add an additional cohort to the ongoing Phase 2a
study in cholangiocarcinoma, evaluating opaganib in combination
with RHB-107, subject to discussions with the U.S. FDA.
About Opaganib (ABC294640,
Yeliva®)Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor with demonstrated dual anti-inflammatory and
antiviral activity that targets a host cell component, potentially
minimizing the likelihood of viral resistance. Opaganib has also
shown anticancer activity and has the potential to target multiple
oncology, viral, inflammatory and gastrointestinal indications.
Opaganib received Orphan Drug designation
from the U.S. FDA for the treatment of cholangiocarcinoma and is
being evaluated in a Phase 2a study in advanced cholangiocarcinoma
and in a Phase 2 study in prostate cancer. Opaganib is also being
evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for
the treatment of severe COVID-19.
Preclinical data have demonstrated both
anti-inflammatory and antiviral activities of opaganib, with the
potential to reduce inflammatory lung disorders, such as pneumonia,
and mitigate pulmonary fibrotic damage. Opaganib demonstrated
potent antiviral activity against SARS-CoV-2, the virus that causes
COVID-19, completely inhibiting viral replication in an in
vitro model of human lung bronchial tissue. Additionally,
preclinical in vivo studies3 have demonstrated that opaganib
decreased fatality rates from influenza virus infection and
ameliorated Pseudomonas aeruginosa-induced lung injury by reducing
the levels of IL-6 and TNF-alpha in bronchoalveolar lavage
fluids.
Opaganib was originally developed by
U.S.-based Apogee Biotechnology Corp. and completed multiple
successful preclinical studies in oncology, inflammation, GI, and
radioprotection models, as well as a Phase 1 clinical study in
cancer patients with advanced solid tumors and an additional Phase
1 study in multiple myeloma.
Under a compassionate use program, patients with
COVID-19 (as classified by the WHO ordinal scale) were treated with
opaganib in a leading hospital in Israel. Data from the treatment
of these first patients with severe COVID-19 with opaganib have
been published2. Analysis of treatment outcomes suggested
substantial benefit to patients treated with opaganib under
compassionate use in both clinical outcomes and inflammatory
markers as compared to a retrospective matched case-control group
from the same hospital. All patients in the opaganib-treated group
were discharged from hospital on room air without requiring
intubation and mechanical ventilation, whereas 33% of the matched
case-control group required intubation and mechanical ventilation.
Median time to weaning from high-flow nasal cannula was reduced to
10 days in the opaganib-treated group, as compared to 15 days in
the matched case-control group.
The development of opaganib has been
supported by grants and contracts from U.S. federal and state
government agencies awarded to Apogee Biotechnology Corp.,
including from the NCI, BARDA, the U.S. Department of Defense and
the FDA Office of Orphan Products Development.
The ongoing studies with opaganib are
registered on www.ClinicalTrials.gov, a web-based service by
the U.S. National Institute of Health, which provides public access
to information on publicly and privately supported clinical
studies.
About RHB-107
(upamostat)RHB-107 is a proprietary, first-in-class,
orally-administered potent inhibitor of several serine proteases
with demonstrated antiviral and potential tissue-protective
effects. This combined antiviral and potential tissue-protective
action make RHB-107 a strong candidate for evaluation as a
treatment for COVID-19. A U.S. Phase 2/3 study with RHB-107 in an
outpatient setting is planned to be initiated later this year. In
addition, RHB-107 has potential in targeting cancer, inflammatory
lung diseases and gastrointestinal diseases, and has undergone
several Phase 1 studies and two Phase 2 studies, demonstrating its
clinical safety profile in over 300 patients. RedHill acquired the
exclusive worldwide rights to RHB-107, excluding China, Hong Kong,
Taiwan and Macao, from Germany’s Heidelberg Pharmaceuticals
(formerly WILEX AG) for all indications.
About RedHill BiopharmaRedHill
Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical
company primarily focused on gastrointestinal and infectious
diseases. RedHill promotes the gastrointestinal drugs,
Movantik® for opioid-induced constipation in
adults with non-cancer pain4, Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in adults5,
and Aemcolo® for the treatment of travelers’
diarrhea in adults6. RedHill’s key clinical late-stage
investigational development programs include: (i)
RHB-204, with a planned Phase 3 study for
pulmonary nontuberculous mycobacteria (NTM) infections; (ii)
opaganib (Yeliva®), a
first-in-class SK2 selective
inhibitor targeting multiple indications with a Phase 2/3 program
for COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-104, with
positive results from a first Phase 3 study for Crohn's disease;
(iv) RHB-102 (Bekinda®), with
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D; (v)
RHB-107, a Phase 2-stage first-in-class, serine
protease inhibitor, targeting cancer and inflammatory
gastrointestinal diseases and is also being evaluated for COVID-19
and (vi) RHB-106, an encapsulated
bowel preparation. More information about the Company is available
at www.redhillbio.com. This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are based
on certain assumptions and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company’s
control and cannot be predicted or quantified, and consequently,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and
uncertainties, include without limitation, the risk that the
Company will not succeed in adding a third cohort to its ongoing
Phase 2a clinical study in patients suffering from advanced
cholangiocarcinoma, in which the Company expects to evaluate the
efficacy of opaganib in combination with RHB-107; as well as other
risks and uncertainties associated with (i) the initiation, timing,
progress and results of the Company’s research, manufacturing,
pre-clinical studies, clinical trials, and other therapeutic
candidate development efforts, and the timing of the commercial
launch of its commercial products and ones it may acquire or
develop in the future; (ii) the Company’s ability to advance its
therapeutic candidates into clinical trials or to successfully
complete its pre-clinical studies or clinical trials or the
development of a commercial companion diagnostic for the detection
of MAP; (iii) the extent and number and type of additional studies
that the Company may be required to conduct and the Company’s
receipt of regulatory approvals for its therapeutic candidates, and
the timing of other regulatory filings, approvals and feedback;
(iv) the manufacturing, clinical development, commercialization,
and market acceptance of the Company’s therapeutic candidates and
commercial products; (v) the Company’s ability to successfully
commercialize and promote Talicia®, and Aemcolo® and Movantik®;
(vi) the Company’s ability to establish and maintain corporate
collaborations; (vii) the Company's ability to acquire products
approved for marketing in the U.S. that achieve commercial success
and build its own marketing and commercialization capabilities;
(viii) the interpretation of the properties and characteristics of
the Company’s therapeutic candidates and the results obtained with
its therapeutic candidates in research, pre-clinical studies or
clinical trials; (ix) the implementation of the Company’s business
model, strategic plans for its business and therapeutic candidates;
(x) the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and commercial products and its ability to operate its
business without infringing the intellectual property rights of
others; (xi) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the
Company; (xii) estimates of the Company’s expenses, future
revenues, capital requirements and needs for additional financing;
(xiii) the effect of patients suffering adverse experiences using
investigative drugs under the Company's Expanded Access Program;
(xiv) competition from other companies and technologies within the
Company’s industry; and (xv) the hiring and maintaining employment
of executive managers. More detailed information about the Company
and the risk factors that may affect the realization of
forward-looking statements is set forth in the Company's filings
with the Securities and Exchange Commission (SEC), including the
Company's Annual Report on Form 20-F filed with the SEC on March 4,
2020. All forward-looking statements included in this press release
are made only as of the date of this press release. The Company
assumes no obligation to update any written or oral forward-looking
statement, whether as a result of new information, future events or
otherwise unless required by law.
Company contact:Adi FrishChief Corporate &
Business Development Officer RedHill
Biopharma+972-54-6543-112adi@redhillbio.com |
Media contact (U.S.):Bryan GibbsVice PresidentFinn
Partners+1 212 529 2236bryan.gibbs@finnpartners.com |
________________________
1 Opaganib (Yeliva®, ABC294640) and RHB-107
(upamostat, WX-671) are investigational new drugs, not available
for commercial distribution.2 Faizal ZA et al. Abstract 3078:
Effects of upamostat and opaganib on cholangiocarcinoma patient
derived xenografts. Cancer Res August 15
2020 (80) (16
Supplement) 3078; DOI: 10.1158/1538-7445.AM2020-30783
Xia C. et al. Transient inhibition of sphingosine kinases confers
protection to influenza A virus infected mice. Antiviral Res. 2018
Oct; 158:171-177. Ebenezer DL et al. Pseudomonas
aeruginosa stimulates nuclear sphingosine-1-phosphate
generation and epigenetic regulation of lung inflammatory injury.
Thorax. 2019 Jun;74(6):579-591.4 Full prescribing information for
Movantik® (naloxegol) is available at: www.Movantik.com.5 Full
prescribing information for Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.6 Full
prescribing information for Aemcolo® (rifamycin) is available at:
www.Aemcolo.com.
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