Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical stage drug development company with the
industry’s leading pipeline focused on treating inflammatory and
fibrotic diseases by targeting the endocannabinoid system,
announced today that the U.S. Patent and Trademark Office (“USPTO”)
issued U.S. Patent No. 10,085,964 to the Company. This patent
includes claims covering the use of pharmaceutical compositions
comprising lenabasum for the treatment of all fibrotic diseases,
including Corbus’ lead indications systemic sclerosis,
dermatomyositis, cystic fibrosis and others. The patent provides
exclusivity in the U.S. for the use of lenabasum through 2034. This
patent follows the previously issued U.S. Patent Nos. 9,801,849 and
9,820,964 covering uses of lenabasum in multiple inflammatory and
fibrotic diseases, including systemic lupus erythematosus, multiple
sclerosis, rheumatoid arthritis, psoriasis and others.
This new patent is part of an expanding and
comprehensive portfolio of patents, patent applications and other
intellectual property covering the composition, synthesis,
manufacturing, formulation and uses of lenabasum for the treatment
of a variety of indications including the Company’s lead
indications: systemic sclerosis, dermatomyositis, cystic fibrosis
and systemic lupus erythematosus. Lenabasum is a synthetic oral
drug candidate designed to resolve chronic inflammation and
fibrosis through the activation of CB2 to stimulate production of
specialized pro-resolving mediators, inhibition of pro-inflammatory
mediators and tissue infiltration with inflammatory cells as well
as cessation of fibrogenic processes.
“The issuance of this third key patent
reinforces lenabasum’s unique properties to treat diseases that
typically have limited therapeutic options for patients,” said Mark
Tepper, Ph.D., President and Chief Scientific Officer of Corbus.
“This newly issued patent, along with the previously issued U.S.
patent Nos. 9,801,849 and 9,820,964, provides Corbus with broad and
long-term intellectual property rights to lenabasum through
2034.”
About Lenabasum
Lenabasum is a rationally-designed, oral,
small-molecule that selectively binds as an agonist to the
cannabinoid receptor type 2 (CB2). CB2 is preferentially expressed
on activated immune cells, fibroblasts, muscle cells, and
endothelial cells. In both animal and human studies conducted
to-date, lenabasum induces the production of Specialized
Pro-resolving lipid Mediators (“SPMs”) that activate endogenous
pathways which resolve inflammation and speed bacterial clearance
without immunosuppression. Lenabasum also has a direct effect on
fibroblasts to limit production of fibrogenic growth factors and
extracellular connective tissue that lead to tissue fibrosis
(scarring). Data from animal models and human clinical studies show
lenabasum reduces expression of genes and proteins involved in
inflammation and fibrosis. Lenabasum demonstrates promising
activity in animal models of skin and lung inflammation and
fibrosis in systemic sclerosis (SSc). Lenabasum is also active in
animal models of lung infection and inflammation in cystic fibrosis
and joint inflammation and scarring in rheumatoid arthritis.
Lenabasum has demonstrated favorable safety and
tolerability profiles in clinical studies to date. Lenabasum
improved multiple physician-assessed and patient-reported efficacy
outcomes in Phase 2 studies in patients with diffuse cutaneous SSc
and skin-predominant dermatomyositis. Lenabasum also reduced
pulmonary exacerbations in a Phase 2 cystic fibrosis study.
Additional clinical studies are being conducted and/or planned to
confirm these results and support applications for regulatory
approval.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a Phase
3 clinical-stage pharmaceutical company focused on the development
and commercialization of novel therapeutics to treat inflammatory
and fibrotic diseases by leveraging its industry leading pipeline
of endocannabinoid system-targeting drug candidates. The Company's
lead product candidate, lenabasum, is a novel, synthetic, oral,
selective cannabinoid receptor type 2 (CB2) agonist designed to
resolve chronic inflammation and fibrotic processes. Lenabasum is
currently being evaluated in systemic sclerosis, cystic fibrosis,
dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights
to develop, manufacture and market drug candidates from more than
600 novel compounds targeting the endocannabinoid system from
Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd
generation, peripherally-restricted, selective cannabinoid receptor
type 1 (CB1) inverse agonist specifically designed to eliminate
blood-brain barrier penetration and brain CB1 receptor occupancy
that mediate the neuropsychiatric issues associated with
first-generation CB1 inverse agonists. Potential indications for
CRB-4001 include NASH, primary biliary cholangitis, idiopathic
pulmonary fibrosis, radiation-induced pulmonary fibrosis,
myocardial fibrosis after myocardial infarction and acute
interstitial nephritis, among others. CRB-4001 is scheduled to
enter a Phase 1 study in 2019 followed a National Institutes of
Health (NIH)-funded first-in-patient Phase 2 study.
For more information, please visit
www.CorbusPharma.com and connect with the Company on Twitter,
LinkedIn, and Facebook.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to the Company's product
development, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of
operations, business strategies, potential growth opportunities and
other statement that are predictive in nature. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets
in which we operate and management's current beliefs and
assumptions.
These statements may be identified by the use of
forward-looking expressions, including, but not limited to,
"expect," "anticipate," "intend," "plan," "believe," "estimate,"
"potential, "predict," "project," "should," "would" and similar
expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve
known and unknown risks, uncertainties, and other factors which may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such
factors include those set forth in the Company's filings with the
Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Source: Corbus Pharmaceuticals Holdings, Inc.
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Investor Contacts:
Institutional Investor Inquiries
Ted Jenkins, Senior Director, Investor Relations and Communications
Corbus Pharmaceuticals, Inc.
Phone: +1 (617) 415-7745
Email: ir@corbuspharma.com
All Other Investor Inquiries
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (833) 475-8247
Email: crbp@jtcir.com
Media Contact
Eliza Schleifstein
Scient Public Relations
Phone: + 1 (917) 763-8106
Email: eliza@scientpr.com
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