Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on
becoming a leader in the development and commercialization of
treatments for rare and orphan diseases, today announced that its
wholly-owned subsidiary, Aevi Genomic Medicine, LLC (“Cerecor”),
has entered into an expanded agreement with Kyowa Kirin Co., for
exclusive worldwide rights to develop, manufacture and
commercialize CERC-002, Kyowa Kirin’s first-in-class fully human
anti-LIGHT (tumor necrosis factor superfamily member 14, TNFSF14)
monoclonal antibody for all indications.
“We are pleased to expand our agreement for this
promising first-in-class asset with Kyowa Kirin, a global leader in
innovative antibody engineering technology,” said Mike Cola, Chief
Executive Officer of Cerecor. “We have recently demonstrated
clinically meaningful and statistically significant results with
CERC-002 in patients with COVID-19 ARDS and will continue to
explore the role of LIGHT in additional inflammatory disorders. We
believe the expansion of this agreement enables us to potentially
develop this innovative therapy to fill a significant unmet medical
need for a growing number of patients worldwide.”
Under the terms of the agreement, Cerecor will
receive exclusive rights for the development, manufacturing and
commercialization of the antibody for all indications worldwide
including the United States, Europe and Japan. Kyowa Kirin has an
option to retain the rights in Japan. Kyowa Kirin will receive an
up-front payment from Cerecor and is also eligible to receive
additional payments based on achievement of regulatory and
commercial milestones, as well as sales-based royalties and a share
of sublicensing income.
CERC-002 (anti-LIGHT monoclonal
antibody)
CERC-002 is a fully human anti-LIGHT or tumor
necrosis factor superfamily member 14 (TNFSF14) monoclonal antibody
licensed from Kyowa Kirin Co., Ltd. It is the only clinical stage
anti-LIGHT therapy and has the potential to treat a number of
LIGHT-associated immune diseases including cytokine storm-induced
COVID-19 ARDS. It is currently in development for pediatric onset
Crohn’s disease and cytokine storm induced COVID-19 ARDS. Cerecor
has also developed a validated, high sensitivity serum/plasma free
LIGHT assay in collaboration with Myriad RBM.
Role of LIGHT in Acute Inflammatory
Response
LIGHT (homologous to
Lymphotoxin, exhibits inducible
expression and competes with HSV glycoprotein D
for binding to herpesvirus entry mediator, a
receptor expressed on T lymphocytes) is a cytokine
with inflammatory actions encoded by the TNFSF14 gene. LIGHT plays
an important role in regulating immune responses in the lung, gut
and skin. It stimulates T Cell and B Cell response as well as
induces the release of other cytokines such as IL-1, IL-6, IL-8,
IL-10, TNF and GM-CSF. Therefore, LIGHT potentially plays a key
role in immune responses to viral pneumonia and other diseases.
About Cerecor
Cerecor is a biopharmaceutical company focused
on becoming a leader in the development and commercialization of
treatments for rare and orphan diseases. The company is
advancing its clinical-stage pipeline of innovative therapies that
address unmet patient needs within rare and orphan diseases.
The company's rare disease pipeline includes CERC-801, CERC-802 and
CERC-803, which are in development for congenital disorders of
glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in
development for the treatment of complex lymphatic malformations.
The company is also developing two monoclonal antibodies, CERC-002,
and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14)
and is in clinical development for treatment of severe
pediatric-onset Crohn's disease, and COVID-19 acute respiratory
distress syndrome. CERC-007 targets the cytokine IL-18 and is
in clinical development for the treatment of Still’s disease (adult
onset Still’s disease (AOSD) and systemic juvenile idiopathic
arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802
and 803 have all received Orphan Drug Designation and Rare
Pediatric Disease Designation, which makes all four eligible for a
priority review voucher upon FDA approval.
For more information about Cerecor, please visit
www.cerecor.com.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel
medicines with life-changing value. As a Japan-based Global
Specialty Pharmaceutical Company with over 70-year heritage, they
apply cutting-edge science including an expertise in antibody
research and engineering, to address the needs of patients and
society across multiple therapeutic areas including Nephrology,
Oncology, Immunology/Allergy and Neurology. Across their four
regions – Japan, Asia Pacific, North America and EMEA/International
– they focus on their purpose, to make people smile, and are united
by their shared values of commitment to life, teamwork, innovation,
and integrity. You can learn more about the business of Kyowa Kirin
at: https://www.kyowakirin.com.
Forward-Looking Statements
This press release may include forward-looking
statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are statements that
are not historical facts. Such forward-looking statements are
subject to significant risks and uncertainties that are subject to
change based on various factors (many of which are beyond Cerecor’s
control), which could cause actual results to differ from the
forward-looking statements. Such statements may include, without
limitation, statements with respect to Cerecor’s plans, objectives,
projections, expectations and intentions and other statements
identified by words such as “projects,” “may,” “might,” “will,”
“could,” “would,” “should,” “continue,” “seeks,” “aims,”
“predicts,” “believes,” “expects,” “anticipates,” “estimates,”
“intends,” “plans,” “potential,” or similar expressions (including
their use in the negative), or by discussions of future matters
such as: the development of product candidates or products; timing
and success of trial results and regulatory review; potential
attributes and benefits of product candidates; and other statements
that are not historical. These statements are based upon the
current beliefs and expectations of Cerecor’s management but are
subject to significant risks and uncertainties, including: drug
development costs, timing and other risks, including reliance on
investigators and enrollment of patients in clinical trials, which
might be slowed by the COVID-19 pandemic; regulatory risks;
Cerecor's cash position and the need for it to raise additional
capital; general economic and market risks and uncertainties,
including those caused by the COVID-19 pandemic; and those other
risks detailed in Cerecor’s filings with the Securities and
Exchange Commission. Actual results may differ from those set forth
in the forward-looking statements. Except as required by applicable
law, Cerecor expressly disclaims any obligations or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Cerecor’s
expectations with respect thereto or any change in events,
conditions or circumstances on which any statement is based.
For media and investor
inquiries
Chris BrinzeyWestwicke, an ICR
Companychris.brinzey@westwicke.com339-970-2843
or
Schond L. GreenwayInvestor RelationsChief
Financial OfficerCerecor Inc.sgreenway@cerecor.com610-522-6200
office
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