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 Patent No. 10,154,986 to the Company which claims
pharmaceutical compositions of lenabasum through 2034. The patent
is entitled: “Ultrapure Tetrahydrocannabinol-11-oic acids.” The
issuance of this new patent follows the previously issued U.S.
Patent Nos. 10,085,964, 9,801,849 and 9,820,964 covering uses of
lenabasum in multiple inflammatory and fibrotic diseases, including
scleroderma, dermatomyositis, cystic fibrosis and systemic lupus
erythematosus as well as multiple sclerosis, rheumatoid arthritis,
psoriasis and other fibrotic and inflammatory diseases.
Lenabasum is a synthetic oral drug candidate
designed to resolve chronic inflammation and fibrosis through the
activation of the CB2 pathway 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.
“We are pleased to receive this new patent
issuance related to lenabasum which reflects the novelty and
uniqueness of the composition. The issuance of this patent
reinforces the lenabasum composition’s unique properties and
combined with the prior issued patents provides exclusivity for the
use of lenabasum for the treatment of multiple inflammatory and
fibrotic diseases that have limited therapeutic options. We remain
dedicated to pursuing the expansion of our lenabasum product
portfolio as we strive to become leaders in the field,” said Mark
Tepper, Ph.D., President and Chief Scientific Officer of
Corbus.
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 has
induced the production of Specialized Pro-resolving lipid Mediators
(“SPMs”) that activate endogenous pathways which resolve
inflammation and speed bacterial clearance without
immunosuppression. Lenabasum is also believed to have 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 suggest that lenabasum can reduce expression of genes and
proteins involved in inflammation and fibrosis. Lenabasum has
demonstrated 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 pipeline of endocannabinoid
system-targeting synthetic 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 designed to eliminate blood-brain
barrier penetration and subsequent brain CB1 receptor occupancy
that mediates the neuropsychiatric adverse events 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. Corbus plans to enter a Phase
1 study of CRB-4001 in 2019, intended to be followed by a National
Institutes of Health (NIH)-funded proof-of-concept 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.
Investor Contacts:
Institutional Investor InquiriesTed Jenkins,
Senior Director, Investor Relations and CommunicationsCorbus
Pharmaceuticals, Inc.Phone: +1 (617) 415-7745Email:
ir@corbuspharma.com
All Other Investor InquiriesJenene ThomasJenene
Thomas Communications, LLCPhone: +1 (833) 475-8247Email:
crbp@jtcir.com
Media Contact
Lindsey SmithPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Source: Corbus Pharmaceuticals Holdings, Inc.
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