Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”) announced today that it has licensed the exclusive
worldwide rights to develop, manufacture and market drug candidates
from more than 600 compounds targeting the endocannabinoid system
from Jenrin Discovery LLC (“Jenrin”). The pipeline includes
CRB-4001, Jenrin’s 2nd generation, peripherally-restricted, CB1
inverse agonist targeting liver, lung, heart and kidney fibrotic
diseases. The current portfolio for CRB-4001 includes multiple
issued and pending patents.
“Securing this extensive portfolio of
endocannabinoid system-targeting compounds strongly complements our
existing Phase 3 lead drug lenabasum,” said Yuval Cohen, Ph.D.,
Chief Executive Officer of Corbus. “Our now expanded pipeline is
built on robust underlying science based on the endocannabinoid
system as a master regulator of inflammation and fibrosis in the
body. This transaction is a logical next step in our vision to be a
leader in inflammatory and fibrotic diseases by targeting the
endocannabinoid system with what we believe is one of the
industry’s most innovative pipelines. Plans are underway to advance
one of the pipeline candidates, CRB-4001, into a Phase 1 safety
study before commencing a National Institutes of Health
(“NIH”)-funded first-in-patient Phase 2 study.”
Bob Chorvat, Ph.D. Chief Scientific Officer of
Jenrin, stated, “Jenrin is delighted with this transaction. Corbus
shares our vision for the potential of treating a variety of
diseases through cannabinoid receptor interaction and importantly
has the expertise to pursue promising drug candidates with this
mechanism of action.”
“As we have demonstrated with lenabasum,
rational drug design of synthetic compounds can be applied to
target the endocannabinoid system in specific ways, with the
potential to optimize clinical benefits and reduce side effects,”
commented Mark Tepper, Ph.D., President and Chief Scientific
Officer of Corbus. “Beyond lenabasum and CRB-4001, Corbus now has a
pipeline that we believe will support the advancement of one to two
new drug candidates into clinical testing each year starting in
2020.”
CRB-4001 Planned to Enter Phase 1 in
2019 and has Phase 2 Funding Commitment from NIH
CRB-4001 was developed in collaboration with and
with financial support from the NIH. CRB-4001 was 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 such as
rimonabant.
To provide scientific support for the
development of compounds that target the endocannabinoid system as
therapeutics for a broad range of diseases, Corbus today announced
that George Kunos, M.D., Ph.D., Scientific Director of the National
Institute on Alcohol Abuse and Alcoholism (NIAAA), a part of the
NIH, will join the Company’s Scientific Advisory Board as an
uncompensated member. Dr. Kunos is an expert in the biology of the
endocannabinoid system with a particular focus on its role in the
regulation of metabolic, neuroendocrine, and cardiovascular
functions as well as addictive behaviors, and the related
therapeutic implications.
The National Center for the Advancement of
Translational Science (NCATS), a part of the NIH, conducted and
sponsored IND-enabling studies of CRB-4001. Dr. Kunos led the work
at the NIH to advance CRB-4001 to clinical testing, including
studies in animal models of non-alcoholic fatty liver disease
(NAFLD), type 2 diabetes, diet-induced insulin resistance, and type
2 diabetic nephropathy. Dr. Kunos plans to coordinate a Phase 2
proof-of-concept clinical study at the NIH, following the
completion of a Phase 1 study by Corbus. Before year-end, Corbus
will provide more specific details on the clinical development path
of CRB-4001.
Significant Market Opportunities for Lenabasum and
CRB-4001
Lenabasum, Corbus’ lead ECS-targeting drug
candidate is a synthetic, oral, small-molecule, selective
endocannabinoid system receptor agonist that preferentially binds
to cannabinoid receptor type 2 (CB2). Lenabasum is currently in a
Phase 3 study for treatment of the rare autoimmune disease systemic
sclerosis, which affects approximately 200,000 patients in the
U.S., Europe and Japan. A Phase 3 study of lenabasum for the
treatment of dermatomyositis, another rare autoimmune disease, is
planned to begin at the end of 2018. Dermatomyositis affects
approximately 80,000 patients in the U.S., Europe and Japan.
Lenabasum is currently in a large Phase 2 study for pulmonary
exacerbations in cystic fibrosis patients that is funded in part by
an up to $25 million award from the Cystic Fibrosis Foundation.
Cystic Fibrosis affects approximately 70,000 patients in the U.S.
and Europe. The NIH is also conducting a Phase 2 study of lenabasum
for the treatment of systemic lupus erythematosus, another
autoimmune disease.
Corbus believes CRB-4001 adds additional
significant potential market opportunities to Corbus’ pipeline.
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.
Transaction Terms and Conditions
Under the terms of the exclusive licensing
agreement, Corbus obtained worldwide commercialization rights to
Jenrin’s library of more than 600 endocannabinoid system compounds,
including CRB-4001, as well as a portfolio of issued and pending
patents, for an up-front cash payment and milestone payments to be
paid upon the achievement of certain development and regulatory
milestones for each compound as well as royalty payments for sales
of any Jenrin compound.
Conference Call and Webcast
Information
Corbus management will host a conference call
for investors, analysts and other interested parties on Thursday,
September 20, 2018 at 8:30 a.m. EDT.
The conference call and live webcast will be
accompanied by a slide presentation. To participate in the call,
please dial (877) 407-3978 (domestic) or (412) 902-0039
(international). The live webcast and accompanying slides will be
accessible on the Events page of the Investors section of the
Corbus website, www.corbuspharma.com, and will be archived for 60
days.
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. The Company's lead product candidate,
lenabasum, is a novel, synthetic oral ECS receptor (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.
For more information, please visit
www.CorbusPharma.com and connect with the Company on Twitter,
LinkedIn, and Facebook.
About Jenrin Discovery
Jenrin Discovery LLC, is a privately held,
Pennsylvania-based, discovery stage, life sciences company
specializing in the identification and development of novel
therapies exploiting cutting-edge ECS receptor pathways for the
treatment of metabolic disorders and fibrotic diseases.
About Lenabasum
Lenabasum (formerly known as anabasum) is a
synthetic, oral, small-molecule, selective cannabinoid receptor
type 2 (CB2) agonist that has been shown to preferentially bind to
CB2 expressed on activated immune cells and fibroblasts in animal
studies. CB2 activation triggers physiologic pathways that resolve
inflammation, speed bacterial clearance and halt fibrosis. CB2
activation also induces the production of specialized pro-resolving
lipid mediators that activate an endogenous cascade responsible for
the resolution of inflammation and fibrosis, while reducing
production of multiple inflammatory mediators. Through activation
of CB2, lenabasum also is believed to have a direct effect on
fibroblasts to halt tissue scarring. In preclinical and clinical
studies conducted so far, lenabasum has been shown to induce
resolution rather than immunosuppression by triggering biological
pathways to turn "off" chronic inflammation and fibrotic processes.
Lenabasum has demonstrated promising potency in preclinical models
of inflammation and fibrosis. Preclinical data and clinical studies
to date have shown lenabasum to have a favorable safety,
tolerability and pharmacokinetic profile. Data to date suggest that
the drug may have clinical benefit as well as a beneficial impact
on inflammatory and immunological markers in Phase 2 studies in
diffuse cutaneous systemic sclerosis, dermatomyositis and cystic
fibrosis. Additional clinical studies are being conducted and/or
planned to confirm these preliminary results and support
applications for regulatory approval.
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.
###
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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