Chemomab Therapeutics and AGC Biologics Expand Partnership to Manufacture CM-101 for Phase II/III
June 23 2021 - 8:30AM
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.
Investor Relations: Irina
Koffler LifeSci Advisor, LLC Phone:
+1-917-734-7387 ir@chemomab.com
Chemomab
Therapeutics: Sharon Elkobi VP,
Business Development Phone:
+972773310156 bd@chemomab.com
Matteo Pellegrino
AGC Biologics
mpellegrino@agcbio.com
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