Chemomab Therapeutics Ltd. has strengthened its intellectual property portfolio for CM-101, securing new patents in Brazil, Israel, and Europe for its first-in-class monoclonal antibody targeting primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. The company announced these patent grants as it prepares for midyear 2024 topline data from its completed Phase 2 PSC trial.
Expanding Global Patent Protection
The Brazilian Patent Office granted Patent No. BR 11 2016 020366 6 "Anti Eotaxin-2 Antibodies That Recognize Additional CCR3-Binding Chemokines," which includes broad claims covering CM-101 and related anti-CCL24 antibodies for treating fibrotic, inflammatory and autoimmune diseases. The patent, published January 2, 2024, provides protection with claims expiring in 2035.
Israeli Patent No. 269094 "Anti CCL24 (Eotaxin2) Antibodies for Use in the Treatment of Hepatic Diseases" covers CM-101's use in liver diseases including PSC, with a grant date of February 2, 2024, and claims expiring in 2038. The European Patent Office also granted European Patent Application No. 18717135.0 with the same title on March 20, 2024, covering CM-101's use in hepatic diseases across European markets.
"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.
Unique Mechanism Targets Unmet Medical Need
CM-101 is a monoclonal antibody that neutralizes CCL24, a soluble protein that drives inflammatory and fibrotic pathways central to fibro-inflammatory diseases. 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 approach has been shown to inhibit fibrogenesis and interfere with core PSC pathways.
PSC represents a significant unmet medical need as a potentially lethal condition that lacks any FDA-approved therapies and frequently requires liver transplantation. The disease affects the bile ducts in the liver, causing inflammation and scarring that can progress to liver failure.
Clinical Development Progress
Patient enrollment has been completed in CM-101's global Phase 2 SPRING trial for PSC treatment, with topline data expected midyear 2024. This represents the first substantial clinical proof-of-concept opportunity for CM-101's therapeutic activity in PSC.
CM-101 demonstrated safety and tolerability 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.
The drug has received Orphan Drug designation in both the U.S. and European Union, and the FDA has awarded CM-101 Fast Track designation for treating PSC in adults, recognizing the significant unmet medical need in this patient population.
Comprehensive IP Strategy
In combination with 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 across multiple indications until 2038, with the possibility of up to five years extension upon market approval.
CCL24's role as a therapeutic target has been validated in extensive clinical and nonclinical studies, with proof-of-concept for CM-101 demonstrated in multiple animal and patient sample studies. Chemomab has also reported positive results from an investigator-initiated study in patients with severe lung injury, and the company's CM-101 program for systemic sclerosis treatment is Phase 2-ready.
