—CM-101 Phase 2 Trial for the Treatment of
Primary Sclerosing Cholangitis (PSC) Has Completed Patient
Enrollment with Topline Data Expected Midyear 2024—
—New CM-101 Patents Granted by
Brazil and Israel Provide
Additional Protections for Composition of Matter and for Use
in Fibrotic Diseases of the Liver, including PSC—
—Further Extend Protections Afforded by
Multiple CM-101 Patents that Have Issued in the U.S., Europe, Israel and Related Territories—
TEL
AVIV, Israel, Feb. 20,
2024 /PRNewswire/ -- Chemomab Therapeutics Ltd.
(Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company
developing innovative therapeutics for fibro-inflammatory diseases
with high unmet need, today announced that the Patent Offices in
Brazil and Israel have granted new patents 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 diseases involving
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 Brazilian composition of matter Patent No. BR 11 2016
020366 6 "Anti Eotaxin-2 Antibodies That Recognize Additional
CCR3-Binding Chemokines" includes claims broadly covering
CM-101 and related anti-CCL24 antibodies per se and specifically
for the treatment of fibrotic, inflammatory and autoimmune
diseases. The grant of the patent was published January 2, 2024, with corresponding first to
expire claims in 2035.
Israeli Patent No. 269094 "Anti CCL24
(Eotaxin2) Antibodies for Use in the Treatment of Hepatic
Diseases" covers the use of CM-101 in the treatment of hepatic
(liver) diseases, including PSC. It has a grant date of
February 2, 2024, with corresponding
first to expire claims in 2038. The new patent supplements existing
Israeli CM-101 composition of matter and related patents.
PSC is a potentially lethal condition that lacks any
FDA-approved therapies and frequently requires liver
transplantation. Unlike the 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.
"These new patents add to the robust intellectual property
protections we have secured for CM-101, with multiple patents
issued and allowed in the U.S., European Union, Israel, and other major territories," said
Adi Mor, PhD, co-founder, Chief
Executive Officer and Chief Scientific Officer of Chemomab. "This
is an exciting time at Chemomab as we prepare for the release of
topline data from our Phase 2 PSC trial, which offers the first
substantial clinical proof-of-concept of CM-101's therapeutic
activity and represents a potential major catalyst for the
company."
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 recently awarded CM-101 Fast Track
designation for the treatment of PSC in adults.
About CM-101
CM-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. 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.
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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SOURCE Chemomab Therapeutics Ltd