—Proteomic Analysis of Human Samples
Highlights the Unique Role of CCL24 in Activating Key PSC-related
Disease Mechanisms Involving Immune Cell Trafficking and HSC
Activation, Further Confirming the Potential of Chemomab's
CCL24-Neutralizing Antibody CM-101 as a Promising Therapy for
PSC—
—CM-101 Phase 2 PSC Trial Has Completed
Patient Enrollment with Topline Data Readout Targeted for Midyear
2024—
TEL
AVIV, Israel, Jan. 30,
2024 /PRNewswire/ -- Chemomab Therapeutics Ltd.
(Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company
focused on the discovery and development of innovative therapeutics
for fibro-inflammatory diseases with high unmet need, today
announced publication of proteomic analyses that further
demonstrate the unique role of the soluble protein CCL24 in driving
pathologies associated with the rare fibrotic liver disease primary
sclerosing cholangitis (PSC). The new studies reinforce the
extensive existing evidence showing that Chemomab's first-in-class
CCL24-neutralizing antibody CM-101 can interrupt these destructive
processes. The study, "The Role of CCL24 in Primary Sclerosing
Cholangitis: Bridging Patient Serum Proteomics to Preclinical
Data"1 has been published in the current online
version of the peer-reviewed journal Cells.
"The patient sample and other proteomic analyses reported in
this publication add to the large and growing body of data showing
that CCL24 is a major driver of PSC pathology, providing more
detail about its central role in orchestrating the fibrosis and
inflammation underlying PSC progression," said Adi Mor, PhD, co-founder, Chief Executive
Officer and Chief Scientific Officer of Chemomab. "These new data
further validating our CCL24 target and the clinical rationale for
our CCL24-neutralizing antibody are especially timely as we look
forward to our CM-101 Phase 2 topline readout expected midyear,
which has the potential to deliver the first significant clinical
proof-of-concept of CM-101's therapeutic activity in PSC, a lethal
disease with no FDA approved therapies."
The studies included advanced proteomic analyses of serum
samples from PSC patients and healthy controls to further
investigate the involvement of CCL24 in PSC and its association
with specific disease-related pathways. They confirmed the
exclusive association of CCL24 with fundamental PSC mechanisms,
with no similar association seen with two other related proteins
(CCL11 and CCL26) sharing the same receptor, emphasizing CCL24's
unique potential as a target for PSC therapies. Additional studies
showed that CCL24 directly contributes to the development of
fibrosis and inflammation in PSC via recruitment of monocytes and
neutrophils and activation of hepatic stellate cells (HSCs), a
major source of the myofibroblasts that are a key driver of liver
fibrogenesis. Notably, an invitro analysis pinpointed a
CCL24-dependant proteomic signature in HSCs treated with CCL24 that
is capable of stratifying PSC patients based on disease severity,
offering promise for future disease activity monitoring.
CM-101 is a first-in-class CCL24-neutralizing monoclonal
antibody whose dual anti-inflammatory and anti-fibrotic activity
has demonstrated disease modifying potential in nonclinical studies
of PSC and other fibro-inflammatory disorders. CM-101 has Orphan
Drug designation for PSC in the U.S. and the European Union and was
recently awarded Fast Track designation by the FDA for the
treatment of PSC in adults.
About Primary Sclerosing Cholangitis
PSC is a rare,
progressive liver disease characterized by inflammation and
fibrosis (scarring) of the bile ducts that can lead to cirrhosis of
the liver, liver failure and death. PSC also increases the risk of
various cancers, which account for about half of PSC-related
mortality. PSC affects an estimated 30,000 patients in the U.S. and
about 80,000 worldwide. The underlying cause of PSC is unknown, but
about 75% of patients also have inflammatory bowel disease.
Currently there are no approved therapies for PSC. Liver
transplantation is common in advanced cases, but even then, PSC
re-occurs in about 20% of transplanted patients. There is a high
unmet need for therapeutic options to address the symptoms and
modify the progression of this devastating illness.
1 Greenman, R.; Snir, T.; Katav, A.;
Aricha, R.; Mishalian, I.; Hay, O.; Frankel, M.; Lawler, J.;
Saffioti, F.; Pinzani, M.; et al. The Role of CCL24 in Primary
Sclerosing Cholangitis: Bridging Patient Serum Proteomics to
Preclinical Data. Cells 2024, 13, 209.
https://doi.org/10.3390/cells13030209
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 expectation that Chemomab will
report topline data from the PSC clinical trial by mid-year 2024;
the length, duration and impact of the war in Israel on Chemomab's business and operations;
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 those 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, except as
required by law.
About Chemomab Therapeutics Ltd.
Chemomab is a
clinical stage biotechnology company developing innovative
therapeutics for fibro-inflammatory diseases with high unmet need.
Based on the unique and pivotal role of CCL24 in promoting fibrosis
and inflammation, Chemomab developed CM-101, a monoclonal antibody
that neutralizes CCL24 activity. In preclinical and clinical
studies, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases. Chemomab
has reported encouraging results from three clinical trials of
CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver
fibrosis trial in NASH patients and an investigator-initiated study
in patients with severe lung injury. The CM-101 program for the
treatment of systemic sclerosis is Phase 2-ready. A Phase 2 trial
in primary sclerosing cholangitis has completed patient enrollment,
with topline data expected midyear 2024. For more information about
Chemomab, visit chemomab.com.
Contacts:
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
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