Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis

Rhea-AI Summary

Chemomab Therapeutics (Nasdaq: CMMB) receives a new patent from the European Patent Office for CM-101, a monoclonal antibody targeting CCL24 for treating liver diseases, including Primary Sclerosing Cholangitis. The patent extends protections in key European markets and complements existing patents in the U.S., Europe, Israel, and other regions. CM-101 is currently in Phase 2 SPRING trial for PSC, with promising results expected by mid-2024.

Biotech Patent Analyst

The grant of a new European patent to Chemomab for the use of CM-101 in treating liver diseases including primary sclerosing cholangitis (PSC) represents a strategic move that strengthens the company's intellectual property position in Europe. By securing this patent, Chemomab ensures exclusivity in the commercialization of CM-101 for these indications, potentially deterring competition and fostering a more favorable market environment.

From a business perspective, patents are vital for biotech firms as they provide a time-limited monopoly on the market, which can be important for recouping research and development investments. The exclusivity until 2038, with a possible five-year extension, aligns with industry norms for biologic drugs and offers a lengthy window to capitalize on the innovation. This patent protection can be a significant value driver, particularly for a company like Chemomab that specializes in treatments for rare diseases with high unmet needs.

Investors often look for such milestones as indicators of a company's potential for long-term revenue generation. The patent news, coupled with the upcoming topline data from the Phase 2 PSC trial, could be a pivotal moment for Chemomab. Positive trial results may lead to increased investor confidence and a positive impact on the company's stock performance.

Healthcare Market Analyst

Chemomab's focus on rare fibro-inflammatory diseases, such as PSC, taps into a niche yet critical healthcare segment. The lack of FDA-approved therapies for PSC and the severe outcome of the disease, which often necessitates liver transplantation, underscores the high unmet need and the market potential for CM-101. The dual mechanism of action of CM-101, targeting both fibrosis and inflammation, sets it apart from other drugs in development, potentially offering a competitive advantage in terms of efficacy.

Market exclusivity granted by patents, combined with Orphan Drug and Fast Track designations, can lead to expedited development and review processes, which are attractive to investors. These designations can also result in additional market exclusivity upon approval, tax credits and waiver of certain regulatory fees, further enhancing the financial viability of CM-101.

However, it is important to note that the actual market impact will depend on the successful completion of clinical trials and subsequent regulatory approvals. As such, while the patent grant is a positive development, it is the clinical outcomes and regulatory milestones that will ultimately dictate the commercial success of CM-101.

Clinical Trials Specialist

The completion of patient enrollment in the global Phase 2 SPRING trial for CM-101 is a critical step forward for Chemomab. The trial's progress is indicative of the company's ability to execute its clinical development plans, an aspect closely monitored by stakeholders. The anticipation of topline data readout midyear adds a time-sensitive dimension to the company's prospects.

As a clinical trials specialist, it's clear that the efficacy and safety data from the Phase 2 trial will be pivotal in determining CM-101's therapeutic potential. Given that PSC is a condition with no approved therapies, the demonstration of a clear clinical benefit could position CM-101 as a frontrunner in the market. Moreover, positive results could pave the way for breakthrough therapy designation, which may further expedite the development and review process.

It is also essential to understand that the complexity of PSC, characterized by its multifactorial pathogenesis, requires a nuanced approach. CM-101's unique dual mechanism of action could potentially address the underlying disease processes more effectively than monotherapies targeting fibrosis or inflammation alone. The clinical trial outcomes will be highly anticipated, as they will offer insights into the practical application of this novel approach.

—European Patent Office Grants New Patent Covering Use of CM-101 for the Treatment of Multiple Liver Diseases including Primary Sclerosing Cholangitis—

—Further Extends Protections Afforded by CM-101 Composition of Matter and Methods and Use Patents That Have Issued in the U.S., Europe, Israel and Related Territories—

TEL AVIV, Israel, March 25, 2024 (GLOBE NEWSWIRE) -- 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-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.

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

What is the ticker symbol for Chemomab Therapeutics ?

The ticker symbol for Chemomab Therapeutics is CMMB.

What is the new patent granted by the European Patent Office for Chemomab?

The European Patent Office granted a new patent covering the use of CM-101 for the treatment of liver diseases, including Primary Sclerosing Cholangitis.

What is CM-101 and what is its target?

CM-101 is a monoclonal antibody developed by Chemomab Therapeutics that targets CCL24, a novel disease target involved in fibrosis and inflammation.

What clinical trial is CM-101 currently in?

CM-101 is currently being assessed in the global Phase 2 SPRING trial for the treatment of Primary Sclerosing Cholangitis.

What is the significance of the new European patent for CM-101?

The new European patent extends intellectual property protection for CM-101 in key European markets, specifically for the treatment of liver diseases, including PSC.