Chemomab Therapeutics Announces New Publications Reinforcing the Clinical Potential of Its CCL24-Neutralizing Antibody CM-101 in Primary Sclerosing Cholangitis
18 Giugno 2024 - 1:00PM
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical
stage biotechnology company developing innovative therapeutics for
fibro-inflammatory diseases with high unmet need, today announced a
new scientific publication that further confirms the important role
of the soluble protein CCL24 in the pathologies underlying the rare
fibrotic liver disease primary sclerosing cholangitis (PSC). The
new study reinforces the extensive evidence showing the potential
of Chemomab’s CCL24-neutralizing antibody, CM-101, to interrupt the
biological processes driving PSC disease progression and severity.
The study, “Machine Learning Identifies Key Proteins in Primary
Sclerosing Cholangitis Progression and Links High CCL24 to
Cirrhosis”
1 has been published in the current
online version of the peer-reviewed International Journal of
Molecular Science.
The study applied machine learning to proteomic profiles of PSC
patient sera to assess the involvement of CCL24 and to identify
markers of disease presence, severity and cirrhosis. The pathway
analysis underscored the importance of both fibrosis-related
pathways and pathways associated with immune response and
inflammation in PSC. Notably, the analysis showed that enrichment
for PSC-related biological pathways was associated with high levels
of CCL24 and that patients with cirrhosis had higher levels of
CCL24, providing further evidence for the role of CCL24 in disease
progression and severity. The authors also noted that the
biomarkers identified in this study have significant translational
importance, offering potential advancements in the monitoring of
disease progression in clinical settings.
“These proteomic analyses add to the large body of data showing
that CCL24 is a major driver of PSC disease progression and
severity. They also confirm the importance of both fibrotic and
inflammation/immune-related pathways in PSC, highlighting the
relevance of the dual anti-fibrotic and anti-inflammatory activity
of CM-101,” said Adi Mor, PhD, co-founder, Chief Executive Officer
and Chief Scientific Officer of Chemomab. “We look forward to our
CM-101 PSC Phase 2 topline data readout in the coming weeks, which
has the potential to provide the first significant clinical
proof-of-concept of CM-101’s therapeutic activity in this lethal
disease with no FDA approved therapies.”
A second study published in the online edition of the journal
Drug Safety, Targeting CCL24 in Inflammatory and Fibrotic Diseases:
Rationale and Results from Three CM-101 Phase 1 Studies,2
summarized the findings of three Phase 1 studies3 of CM-101. It
concluded that CM-101 successfully neutralizes CCL24, a key factor
linked to inflammatory and fibrotic diseases. Phase 1a studies of
intravenous (IV) and subcutaneous (SC) administration of CM-101 in
healthy participants demonstrated rare and mild adverse events. In
Phase 1b studies in patients with metabolic dysfunction-associated
steatotic liver disease (MASLD), both IV and SC administered CM-101
exhibited good tolerability, with a notable reduction in serum
levels of inflammatory, fibrotic and collagen turnover biomarkers,
suggesting its therapeutic potential in addressing inflammatory and
fibrotic conditions.
About Primary Sclerosing CholangitisPSC 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. Liver
transplantation is common in advanced cases, but even then, PSC
re-occurs in about 20% of transplanted patients. With no approved
therapies, there is a high unmet need for new drugs to address the
symptoms of PSC and slow or stop the progression of this
devastating illness.
1 Snir, T.; Greenman, R.; Aricha, R.; Frankel,
M.; Lawler, J.; Saffioti, F.; Pinzani, M.; Thorburn, D.; Mor, A.;
Vaknin, I. Machine Learning Identifies Key Proteins in Primary
Sclerosing Cholangitis Progression and Links High CCL24 to
Cirrhosis. Int. J. Mol. Sci. 2024, 25, 6042.
https://doi.org/10.3390/ijms25116042
2 Mor, A., Friedman, S., Hashmueli, S. et al. Targeting CCL24 in
Inflammatory and Fibrotic Diseases: Rationale and Results from
Three CM-101 Phase 1 Studies. Drug Saf (2024).
https://doi.org/10.1007/s40264-024-01436-2
3 Clinical trial retrospective registration NCT06025851,
NCT06037577, and NCT06044467. Date of registration: September
2023
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, 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 clinical and preclinical
studies, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases. Chemomab
has reported positive results from three clinical trials of CM-101
in patients, including a Phase 2a liver fibrosis trial in NASH
patients and an investigator-initiated study in patients with
severe lung injury. A Phase 2 trial in primary sclerosing
cholangitis has completed patient enrollment, with topline data
expected midyear 2024. Chemomab’s CM-101 program for the treatment
of systemic sclerosis is Phase 2-ready with an open U.S. IND. For
more information about Chemomab, visit chemomab.com.
Contacts:
Media & Investors:Chemomab
TherapeuticsBarbara LindheimConsulting Vice PresidentInvestor &
Public Relations, Strategic CommunicationsPhone: +1
917-355-9234barbara.lindheim@chemomab.com IR@chemomab.com
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