TEL AVIV, Israel and
SEATTLE, June 23, 2021 /PRNewswire/ -- Chemomab
Therapeutics, Ltd. (NASDAQ: CMMB), a clinical-stage biotech company
focused on the discovery and development of innovative therapeutics
for fibrosis-related diseases with high unmet need, and AGC
Biologics, a leading global Biopharmaceutical Contract Development
and Manufacturing Organization (CDMO), today announced an expanded
partnership to manufacture CM-101, a Phase II investigational drug
targeting Primary Sclerosing Cholangitis, Systemic Sclerosis, and
Liver Fibrosis MoA (NASH). Under terms of the agreement, the
companies will work together to optimize, upscale and lock the
CM-101 manufacturing process towards its testing in pivotal studies
while AGC Biologics will manufacture the clinical trial materials
at its site in Copenhagen, to
support phase II/III clinical testing and launch readiness.
"AGC is a high-quality partner with global manufacturing
expertise, and we are pleased to extend our long-standing
relationship as we continue to progress in our clinical
development," said Adi Mor, Chief
Executive Officer. "CM-101 has tremendous potential in treating
fibrosis and inflammation, and we are excited to continue to scale
up our manufacturing capacity ahead of our Phase 3
registration-enabling trials."
Mark Womack, Chief Business
Officer at AGC Biologics added, "We are very pleased that Chemomab
has entrusted us to manufacture CM-101, following successful
delivery of the early phase supply. Our Copenhagen site has the proven experience and
expertise to help Chemomab in its journey towards market supply of
this important therapy."
"The Copenhagen team is excited
to help advance the manufacturing process for CM-101 to the next
phase, and is looking forward to a close collaboration with the
Chemomab team," says AGC Biologics General Manager, Copenhagen, Andrea C.
Porchia.
AGC Biologics' Copenhagen
facility has over 20 years' experience delivering a wide range of
mammalian and microbial programs, including several commercially
approved products. The news comes less than seven months after the
announcement of a €160M expansion project that would double the
production capacity in Denmark to
address increasing market demand.
About CM-101
CM-101 is a first-in-class monoclonal antibody that targets
CCL24 and has been shown to interfere with the underlying biology
of liver, skin and lung fibrosis using a novel and differentiated
mechanism of action. Pre-clinical evidence has shown CM-101
to be an effective therapy with potential to fill the gap in
today's fibrotic disease care. CM-101 has been well-tolerated in
healthy subjects and in NAFLD patients via intravenous or
subcutaneous administrations. Both routes of administration support
long dosing intervals and provide evidence of target engagement and
biological activity in humans. CM-101 Phase 2 safety and efficacy
trials in patients with PSC and Liver fibrosis (NASH) are currently
ongoing and a third Ph2, in Systemic sclerosis, is expected to
initiate by the end of 2021.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract
Development and Manufacturing Organization (CDMO) with a strong
commitment to deliver the highest standard of service as we work
side-by-side with our clients and partners, every step of the way.
We provide world-class development and manufacture of mammalian and
microbial-based therapeutic proteins, plasmid DNA (pDNA), viral
vectors and genetically engineered cells. Our global network spans
the U.S., Europe and Asia, with cGMP-compliant facilities in
Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan,
Italy; and Chiba, Japan and
we currently employ more than 1,700 employees worldwide. Our
commitment to continuous innovation fosters the technical
creativity to solve our clients' most complex challenges, including
specialization in fast-track projects and rare diseases. AGC
Biologics is the partner of choice. To learn more, visit
www.agcbio.com.
About Chemomab Therapeutics Ltd.
Chemomab is a clinical-stage biotech company focusing on
the discovery and development of innovative therapeutics for
fibrosis-related diseases with high unmet need. Based on the unique
and pivotal role of the soluble protein CCL24 in
promoting fibrosis and inflammation, Chemomab
developed CM-101, a monoclonal antibody designed to bind and
block CCL24 activity. CM-101 has potential to treat multiple severe
and life-threatening inflammatory and fibrotic diseases and is
currently undergoing clinical development with primary focus for
the orphan diseases, Primary Sclerosing Cholangitis (PSC) and
Systemic Sclerosis (SSc).
For more information on Chemomab, please
visit www.chemomab.com.
Forward Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act. These
forward-looking statements include, among other things, statements
regarding the clinical development pathway for CM-101; the future
operations of Chemomab and its ability to successfully initiate and
complete clinical trials and achieve regulatory milestones; the
nature, strategy and focus of Chemomab; the development and
commercial potential and potential benefits of any product
candidates of Chemomab; and that the product candidates have the
potential to address high unmet needs of patients with serious
fibrosis-related diseases and conditions. Any statements contained
in this communication that are not statements of historical fact
may be deemed to be forward-looking statements. These
forward-looking statements are based upon Chemomab's current
expectations. Forward-looking statements involve risks and
uncertainties. Because such statements deal with future events and
are based on Chemomab's current expectations, they are subject to
various risks and uncertainties and actual results, performance or
achievements of Chemomab could differ materially from those
described in or implied by the statements in this presentation,
including: the uncertain and time-consuming regulatory approval
process; risks related to Chemomab's ability to correctly manage
its operating expenses and its expenses; Chemomab's plans to
develop and commercialize its product candidates, focusing
on CM-101; the timing of initiation of Chemomab's planned
clinical trials; the timing of the availability of data from
Chemomab's clinical trials; the timing of any planned
investigational new drug application or new drug application;
Chemomab's plans to research, develop and commercialize its current
and future product candidates; the clinical utility, potential
benefits and market acceptance of Chemomab's product candidates;
Chemomab's commercialization, marketing and manufacturing
capabilities and strategy; Chemomab's ability to protect its
intellectual property position; and the requirement for additional
capital to continue to advance these product candidates, which may
not be available on favorable terms or at all. Additional risks and
uncertainties relating to Chemomab's and its business can be found
under the caption "Risk Factors" and elsewhere in Chemomab's
filings and reports with the SEC. Chemomab expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Chemomab's expectations with regard thereto
or any change in events, conditions or circumstances on which any
such statements are based.
AGC Biologics Contact:
Media Contact: Matteo
Pellegrino
mpellegrino@agcbio.com
http://www.agcbio.com/
Chemomab Therapeutics Ltd. Contacts:
Investor Relations:
Irina Koffler
LifeSci Advisors, LLC
Phone: +1-917-734-7387
ir@chemomab.com
Chemomab Therapeutics:
Sharon Elkobi
VP, Business Development
Phone: +972-773-310-156
bd@chemomab.com
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SOURCE ChemomAb Ltd.