—Ex Vivo Studies Using Clinical Samples from Patients with Liver Fibrosis Reinforce the Anti-Fibrotic Activity of CM-101 by Showing the Drug’s Direct Interference with Liver Fibroblast Activation—
—New Translational Data Further Confirms CM-101’s Disease Modifying Activity in Primary Sclerosing Cholangitis—
TEL AVIV, Israel ─ June 6, 2024 ─ Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported that it presented two scientific posters supporting the clinical rationale for the company’s primary sclerosing cholangitis (PSC) program at EASL 2024, the Annual Congress of the European Association for the Study of the Liver, which is taking place June 5-8, 2024 in Milan, Italy. Chemomab also announced a poster presentation at the Gordon Research Conference on Chemotactic Cytokines, held June 2-7, 2024 in Portland, Maine.
The presentations cover a range of topics, from new preclinical studies further elucidating the roles of the novel soluble protein target CCL24 and Chemomab’s CCL24-neutralizing antibody CM-101 in fibro-inflammatory liver disorders, to translational research supporting the clinical development of CM-101 for PSC, a rare and often fatal liver disease.
The first EASL poster describes an ex vivo-developed translational assay designed to further characterize the anti-fibrotic activity of CM-101 in patients with liver disease.1 This study was selected for an EASL 2024 Poster Tour highlighting presentations of special interest. Using a serum-based ex vivo hepatic stellae cell (HSC) activation assay derived from patients with liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH), the study showed that sera from these patients directly activates HSCs and that HSC activation levels were significantly reduced in the sera of patients treated with CM-101. Importantly, a protein signature generated from CCL24-activated HSCs was able to predict PSC disease and its severity. These findings support CM-101’s mode of action in liver fibrosis and are expected to help in characterizing its anti-fibrotic drug effects by serving as a translational tool in PSC clinical trials.
In a second poster2, researchers presented a comprehensive proteomic profiling study of patients with PSC, which was combined with machine learning-based methods to develop a protein signature model that
successfully predicted the presence and severity of PSC when combined with proteins correlated with the Enhanced Liver Function (ELF) biomarker score. The machine learning analysis was also able to identify key proteins associated with PSC progression. Additionally, the model showed that high CCL24 levels were associated with cirrhosis in patients with PSC. The findings emphasize the value of targeting CCL24 in PSC treatment.
“As we approach the topline readout of our CM-101 Phase 2 PSC trial, we welcome the opportunity to highlight important new data at EASL 2024 and at a prestigious Gordon Research Conference,” noted Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “We are especially excited about the novel translational work from our R&D team included in two presentations at EASL. In one, an ex vivo translational assay we developed confirmed that serum from patients with liver fibrosis activates HSCs, a key driver of PSC pathology, and that administration of CM-101 significantly reduces this HSC activation, indicating that inhibition of CCL24 is sufficient to attenuate HSC activation. The second study presented a proteomics and machine learning-based PSC protein signature model developed by Chemomab researchers that has potential as a biomarker for monitoring and assessing drug activity in current and future clinical trials of CM-101.”
The Gordon Conference presentation3 highlighted preclinical studies that provide further evidence of the key role of CCL24 in driving fibro-inflammatory pathways in liver diseases such as primary sclerosing cholangitis, as well as the ability of Chemomab’s CCL24-neutralizing antibody CM-101 to block these effects and attenuate inflammation and fibrosis.
The posters will be available post-conference on the Chemomab website at www.chemomab.com/r-d/.
1 - Ex-vivo translational assay of hepatic stellate cells using patient-derived serum characterizes the anti-fibrotic activity of CM-101, J Amer, A Salhab, R Greenman, A Katav, T Snir, R Aricha, M Frankel, J Lawler, F Saffioti, D Thorburn, M Pinzani, I Vaknin, A Mor and R Safadi, June 6, 2024, Fibrosis/Stellate cell biology session, EASL abstract #380
2 - Machine learning-driven identification of serum protein signature for primary sclerosing cholangitis and enhanced liver fibrosis score, T Snir, R Greenman, A Katav, R Aricha, M Frankel, J Lawler, F Saffioti, D Thorburn, M Pinzani, I Vaknin, A Mor, June 6, 2024, Immune-mediated and cholestatic: Experimental and pathophysiology session, EASL abstract #1032
3 - Attenuating liver fibrosis and inflammation: blocking CCL24 inhibits recruitment of hepatic stellate cells, monocytes and neutrophils and modulates hepatic stellate cell activation, R Greenman, O Hay, I Mishalian, I Vaknin, M Pinzani, D Thorburn, J Amer, A Salhab, R Safadi, A Mor, A Peled, June 2-7, 2024, Gordon Research Conference on Chemotactic Cytokines
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.
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