Chemomab Announces New Patent Awards for Its First-in-Class Agent Nebokitug that is Positioned to Potentially Become the First Approved Drug for Primary Sclerosing Cholangitis
- Secured new patent protections in China and Russia extending coverage up to 2041
- Positive Phase 2 SPRING trial data for nebokitug in PSC treatment
- FDA alignment achieved on regulatory approval pathway
- Potential to become first approved drug for Primary Sclerosing Cholangitis
- Phase 3 trial requires partnership support for advancement
- Regulatory approval pathway success not guaranteed
- Potential commercialization challenges in international markets
Insights
Chemomab strengthens global IP position for nebokitug with new Chinese and Russian patents, critical for commercialization potential in PSC.
Chemomab has secured significant new patent protections for nebokitug (formerly CM-101) in China and Russia, strengthening their intellectual property portfolio for this first-in-class agent targeting primary sclerosing cholangitis (PSC). The Chinese patent (No. ZL 2018 8 0018207.8) covers nebokitug use in hepatic diseases including PSC through 2038, while the Russian patent (RU 2022125176) protects various formulations and doses through 2041.
These patent awards are strategically valuable for three key reasons. First, they complement existing composition of matter and methods patents already secured in major markets including the U.S., Europe, and Japan, creating a comprehensive global IP shield. Second, the timing aligns with Chemomab's reported positive Phase 2 SPRING trial results, which the company characterizes as
The IP strategy demonstrates considerable foresight - by securing method-of-use patents specific to PSC, Chemomab is creating multiple layers of protection around nebokitug. This layered approach is particularly valuable for biological therapeutics, where composition patents alone may be vulnerable to biosimilar competition. The extended protection through 2041 in Russia provides crucial market exclusivity during what would be the prime commercial years following potential approval.
For a small biotechnology company focused on a rare disease with no approved treatments, this expanded patent estate represents a critical asset. It increases the likelihood of securing favorable partnership terms and maximizes the potential commercial value of nebokitug should it successfully navigate the regulatory pathway that the FDA has apparently endorsed.
—New Patents Covering Use of Nebokitug for the Treatment of Liver Diseases including Primary Sclerosing Cholangitis Issued in China and Russia Providing Coverage Up To 2041—
—Further Expands Protections Provided by Nebokitug’s Composition of Matter and Methods and Use Patents Issued in the U.S., Europe, Japan and Additional Key Territories—
TEL AVIV, Israel, June 03, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that its lead product nebokitug (formerly CM-101) has been awarded new patent protections in China and Russia.
Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, commented, “These newly granted patents further strengthen the company’s extensive intellectual property portfolio for nebokitug, reinforcing its leading strategic position in primary sclerosing cholangitis (PSC) established by the positive data from the nebokitug Phase 2 SPRING trial, which we believe represents the most promising clinical results to date in this debilitating and potentially lethal disease that lacks effective treatment. Furthermore, for the first time the FDA has aligned on a clear and straightforward pathway to regulatory approval in PSC. We have amassed a large and comprehensive intellectual property portfolio for nebokitug and are pleased to add these new patents in China and Russia, two significant territories for future commercialization. Enlarging the scope of our patent protections is especially relevant as we continue to advance potential partnerships to support a nebokitug Phase 3 registrational trial in PSC.”
The State Intellectual Property Office of the People's Republic of China has issued Patent No. ZL 2018 8 0018207.8, Anti-CCL24 (Eotaxin 2) Antibodies for Use in the Treatment of Hepatic Disease. This patent protects the usage of nebokitug in hepatic diseases, including primary sclerosing cholangitis, and provides coverage through 2038.
The Federal Service for Intellectual Property of the Russian Federation issued RU Patent 2022125176, A Method of Treatment Using Anti-CCL24 Antibodies. This patent protects the usage of different formulations and doses of nebokitug and provides coverage through 2041.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the risk that certain acknowledgements from the End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC regulatory approval will not materialize into a pathway for regulatory approval; that certain conclusions and assumptions drawn from the EOP2 meeting with the FDA discussed in the press release will prove incorrect and adversely affect the ability for nebokitug to become an FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug will not be consistent with the topline results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for nebokitug in the U.S., Europe or other territories; failure to successfully commercialize nebokitug, if approved by applicable regulatory authorities, in the U.S., Europe or other territories, or to maintain U.S., European or other territory regulatory approval for nebokitug if approved; uncertainties in the degree of market acceptance of nebokitug by physicians, patients, third-party payors and others in the healthcare community; nebokitug development of unexpected safety or efficacy concerns related to nebokitug; failure to successfully conduct future clinical trials for nebokitug, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of nebokitug for commercial or clinical needs, to conduct the Company's clinical trials; changes in laws and regulations applicable to the Company's business and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and uncertainties with respect to the Company's need and ability to access future capital; and the intensity and duration of the current war in Israel, and its impact on our operations in Israel. These risks are not exhaustive. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of our 20-F for the year ended December 31, 2024. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release. Before you invest, you should read the documents we have filed and will file with the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.
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 role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a nebokitug PSC Phase 3 trial. The design of Phase 3 calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential full regulatory approval. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab’s nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: chemomab.com.
Contact:
Media and Investor:
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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