Chemomab Awarded New Patents for CM-101, Its First-in Class Monoclonal Antibody in Clinical Development for Fibro-Inflammatory Diseases

Rhea-AI Summary

Chemomab Therapeutics Ltd. (CMMB) completes patient enrollment for CM-101 Phase 2 trial for treating Primary Sclerosing Cholangitis, with topline data expected in mid-2024. New patents granted in Brazil and Israel enhance protection for CM-101 in fibrotic liver diseases, including PSC.

Positive

• Completion of patient enrollment for Phase 2 trial is a positive milestone.
• New patents in Brazil and Israel strengthen intellectual property rights for CM-101.
• CM-101's unique dual mechanism of action sets it apart from other drugs for PSC.
• Topline data from Phase 2 trial could be a significant catalyst for the company.
• Orphan Drug and Fast Track designations for CM-101 highlight its potential in treating PSC.

Negative

• None.

Insights

Medical Research Analyst

The completion of patient enrollment in Chemomab Therapeutics' Phase 2 trial for CM-101 and the expectation of topline data in mid-2024 are pivotal milestones in the drug's development pathway. The significance of this news lies in the potential market impact of CM-101, assuming the trial results are positive. Primary Sclerosing Cholangitis (PSC) is a disease with no FDA-approved treatments, indicating a high unmet medical need. Should CM-101 prove efficacious and safe, it could become a first-in-class therapy, which often translates into a strong market position and potential pricing power for Chemomab.

Moreover, the granting of new patents in Brazil and Israel enhances the drug's commercial prospects by extending its market exclusivity. This is crucial for biotech companies, as it prevents generic competition and allows recovery of R&D investments. The dual mechanism of action of CM-101, targeting both fibrosis and inflammation, differentiates it from other drugs in development and could lead to broader therapeutic applications, thus potentially increasing the target market size.

Patent Law Expert

Intellectual property rights are a cornerstone of the biotech industry's business model and the issuance of new patents in Brazil and Israel solidifies Chemomab's position. The patents covering the composition of matter and use in fibrotic diseases of the liver, including PSC, until at least 2035 and potentially 2038, provide a lengthy period of market exclusivity. This is particularly important for investors, as the value of a biotech firm is heavily influenced by the strength and duration of its patent portfolio.

The strategic importance of these patents is underscored by their broad claims, which not only cover CM-101 itself but also related anti-CCL24 antibodies. Such breadth can deter competitors and may provide leverage in potential partnerships or licensing deals. The extension of protection until 2038, with the possibility of an additional five-year extension upon market approval, creates a long runway for Chemomab to capitalize on CM-101, should it gain regulatory approval.

Financial Analyst

For investors, the news of Chemomab's progress in the CM-101 Phase 2 trial and the expansion of its patent estate has several financial implications. The anticipation of topline data can create volatility in the company's stock as the market assesses the risk and potential reward. Successful trial results could lead to a surge in Chemomab's valuation due to the prospects of entering a market with a high unmet need.

However, it's important to consider the inherent risks of investing in clinical-stage biotech companies. The high costs associated with drug development and the uncertainty of clinical trial outcomes can pose significant financial risks. Additionally, even with strong patent protection, the commercial success of CM-101 will depend on the drug's efficacy, safety profile and the company's ability to successfully navigate the regulatory approval process and subsequent market challenges, including competition, pricing and reimbursement hurdles.

—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

FAQ

When is the topline data expected for the CM-101 Phase 2 trial for treating PSC?

The topline data for the Phase 2 trial is expected in midyear 2024.

What are the new patents granted for CM-101 in Brazil and Israel?

Brazil granted a patent for the composition of matter broadly covering CM-101 for fibrotic, inflammatory, and autoimmune diseases. Israel granted a patent for using CM-101 in the treatment of hepatic diseases, including PSC.

What makes CM-101 unique in treating PSC compared to other drugs?

CM-101 has a dual mechanism of action that simultaneously blocks fibrosis and inflammation, unlike other drugs in development for PSC.

What designations has CM-101 received from regulatory bodies?

CM-101 has been granted Orphan Drug designation in the U.S. and the E.U., and Fast Track designation by the FDA for treating PSC in adults.

Why are the new patents significant for Chemomab and CM-101?

The new patents enhance intellectual property protection for CM-101 in major territories, potentially safeguarding it until 2038 and providing market exclusivity.