Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis
25 Março 2024 - 8:06AM
Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical
stage biotechnology company developing innovative therapeutics to
treat rare fibro-inflammatory diseases with high unmet need, today
reported that the European Patent Office has granted a new patent
for CM-101, Chemomab’s first-in-class monoclonal antibody that
neutralizes CCL24, a novel disease target that has been shown to
play a critical role in the processes that drive fibrosis and
inflammation. CM-101 is currently being assessed in the global
Phase 2 SPRING trial for the treatment of primary sclerosing
cholangitis (PSC). Patient enrollment in the trial has been
completed, with a topline data readout expected midyear 2024.
The new European patent covers the use of CM-101 and
sequence-related anti-CCL24 antibodies for the treatment of hepatic
(liver) diseases, including PSC.
PSC is a potentially lethal condition that lacks any
FDA-approved therapies and frequently requires liver
transplantation. Unlike other drugs in development for PSC, CM-101
has a unique dual mechanism of action that simultaneously blocks
fibrosis and inflammation. In clinical and preclinical studies,
this distinctive approach has been shown to inhibit fibrogenesis
and interfere with core PSC pathways.
“This new patent covering the use of CM-101 in liver diseases
provides additional intellectual property protection in key
European markets in addition to the CM-101 composition of matter
patent that has already been granted in Europe. It further
supplements the extensive protections afforded by the multiple
patents issued and allowed in the U.S., Israel, China and other
major territories,” said Adi Mor, PhD, co-founder, Chief Executive
Officer and Chief Scientific Officer of Chemomab. “This is an
important time for Chemomab as we prepare for the midyear release
of topline data from our Phase 2 PSC trial, which could provide the
first substantial clinical proof-of-concept of CM-101’s therapeutic
activity and represents a potential major catalyst for the
company.”
European Patent Application No. 18717135.0 “Anti CCL24
(eotaxin2) Antibodies for Use in the Treatment of Hepatic Diseases”
has a grant date of March 20, 2024.
In combination with the five families of CM-101 composition of
matter and use patents that are either issued or pending in major
territories worldwide, these new patents are expected to provide
protection of CM-101 across a number of indications until 2038,
with the possibility of up to five years extension upon market
approval. CM-101 has been granted Orphan Drug designation in the
U.S. and the E.U. and the FDA has awarded CM-101 Fast Track
designation for the treatment of PSC in adults.
About CM-101CM-101 is a monoclonal antibody
that neutralizes CCL24, a soluble protein that helps drive the
inflammatory and fibrotic pathways central to many
fibro-inflammatory diseases. CCL24's role as a therapeutic target
has been validated in extensive clinical and nonclinical studies
and proof-of-concept for CM-101 has been demonstrated in multiple
animal and patient sample studies. CM-101 was safe and well
tolerated in four Phase 1 and Phase 2 clinical trials. Data from a
completed Phase 2a liver fibrosis trial in nonalcoholic
steatohepatitis (NASH) patients showed consistent, positive
improvements in key inflammatory and fibrogenesis-related
biomarkers, including several that may serve as a potential bridge
to activity in PSC. Patient enrollment has been completed in an
ongoing CM-101 Phase 2 PSC trial and a readout of topline data is
expected midyear 2024.
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. For more information about
Chemomab, visit 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 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.
Contacts:
Media and Investors:Barbara LindheimConsulting
Vice President, Investor & Public Relations, Strategic
CommunicationsPhone: +1
917-355-9234barbara.lindheim@chemomab.comIR@chemomab.com
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