New Data Presented at CORA 2025 Conference Highlights Clinical Potential of Chemomab’s Nebokitug in Systemic Sclerosis
Chemomab Therapeutics (Nasdaq: CMMB) presented new data at CORA 2025 supporting the potential of nebokitug (CM-101) as a treatment for systemic sclerosis (SSc). The presentation, scheduled for March 8, 2025, in Venice, Italy, showcases nebokitug as a first-in-class monoclonal antibody targeting CCL24, a key driver in fibro-inflammatory conditions.
The new study, conducted with Dr. Alexandra Balbir-Gurman, analyzed skin and serum samples from SSc patients and demonstrated CCL24's role in induced fibrosis and SSc pathogenesis. A 2024 peer-reviewed study of over 200 SSc patients showed that higher CCL24 levels correlated with severe SSc forms and predicted pulmonary function deterioration and higher 10-year mortality.
Recent positive results from the Phase 2 SPRING trial in PSC patients demonstrated nebokitug's effectiveness in reducing fibro-inflammatory biomarkers, including ELF score, PRO-C3, IL-6, and TGF-β, which are also indicators of SSc activity.
Chemomab Therapeutics (Nasdaq: CMMB) ha presentato nuovi dati al CORA 2025 che supportano il potenziale di nebokitug (CM-101) come trattamento per la sclerosi sistemica (SSc). La presentazione, programmata per l'8 marzo 2025 a Venezia, Italia, mette in evidenza nebokitug come un anticorpo monoclonale di prima classe che mira a CCL24, un fattore chiave nelle condizioni fibro-infiammatorie.
Il nuovo studio, condotto con la Dr.ssa Alexandra Balbir-Gurman, ha analizzato campioni di pelle e siero da pazienti con SSc e ha dimostrato il ruolo di CCL24 nella fibrosi indotta e nella patogenesi della SSc. Uno studio peer-reviewed del 2024 su oltre 200 pazienti con SSc ha mostrato che livelli più elevati di CCL24 erano correlati a forme severe di SSc e predicevano un deterioramento della funzione polmonare e una maggiore mortalità a 10 anni.
I recenti risultati positivi del trial di Fase 2 SPRING in pazienti con PSC hanno dimostrato l'efficacia di nebokitug nella riduzione dei biomarcatori fibro-infiammatori, inclusi il punteggio ELF, PRO-C3, IL-6 e TGF-β, che sono anche indicatori dell'attività della SSc.
Chemomab Therapeutics (Nasdaq: CMMB) presentó nuevos datos en CORA 2025 que respaldan el potencial de nebokitug (CM-101) como tratamiento para la esclerosis sistémica (SSc). La presentación, programada para el 8 de marzo de 2025 en Venecia, Italia, destaca a nebokitug como un anticuerpo monoclonal de primera clase que se dirige a CCL24, un factor clave en condiciones fibro-inflamatorias.
El nuevo estudio, realizado con la Dra. Alexandra Balbir-Gurman, analizó muestras de piel y suero de pacientes con SSc y demostró el papel de CCL24 en la fibrosis inducida y la patogénesis de la SSc. Un estudio revisado por pares de 2024 sobre más de 200 pacientes con SSc mostró que niveles más altos de CCL24 estaban correlacionados con formas severas de SSc y predecían un deterioro de la función pulmonar y una mayor mortalidad a 10 años.
Los recientes resultados positivos del ensayo de Fase 2 SPRING en pacientes con PSC demostraron la efectividad de nebokitug en la reducción de biomarcadores fibro-inflamatorios, incluidos el puntaje ELF, PRO-C3, IL-6 y TGF-β, que también son indicadores de la actividad de la SSc.
Chemomab Therapeutics (Nasdaq: CMMB)는 CORA 2025에서 nebokitug (CM-101)의 전신 경화증(SSc) 치료 가능성을 뒷받침하는 새로운 데이터를 발표했습니다. 2025년 3월 8일 이탈리아 베네치아에서 예정된 발표에서는 CCL24를 표적으로 하는 첫 번째 클래스의 단일클론 항체로서 nebokitug를 소개합니다. CCL24는 섬유성 염증 상태의 주요 원인입니다.
알렉산드라 발비르-구르만 박사와 함께 수행된 새로운 연구는 SSc 환자들의 피부 및 혈청 샘플을 분석하고 CCL24가 유도된 섬유증 및 SSc 병인론에서의 역할을 입증했습니다. 2024년 200명 이상의 SSc 환자를 대상으로 한 동료 검토 연구에서는 CCL24 수치가 높을수록 심각한 SSc 형태와 상관관계가 있으며, 폐 기능 저하 및 10년 사망률 증가를 예측한다고 밝혔습니다.
PSC 환자를 대상으로 한 2상 SPRING 시험에서의 최근 긍정적인 결과는 nebokitug가 ELF 점수, PRO-C3, IL-6 및 TGF-β를 포함한 섬유성 염증 바이오마커의 감소에 효과적임을 입증했습니다. 이러한 바이오마커는 또한 SSc 활동의 지표입니다.
Chemomab Therapeutics (Nasdaq: CMMB) a présenté de nouvelles données lors de CORA 2025 soutenant le potentiel de nebokitug (CM-101) en tant que traitement pour la sclérose systémique (SSc). La présentation, prévue pour le 8 mars 2025 à Venise, en Italie, met en avant nebokitug comme un anticorps monoclonal de première classe ciblant CCL24, un facteur clé dans les conditions fibro-inflammatoires.
La nouvelle étude, réalisée avec la Dr. Alexandra Balbir-Gurman, a analysé des échantillons de peau et de sérum de patients atteints de SSc et a démontré le rôle de CCL24 dans la fibrose induite et la pathogenèse de la SSc. Une étude évaluée par des pairs en 2024 sur plus de 200 patients atteints de SSc a montré que des niveaux plus élevés de CCL24 étaient corrélés à des formes sévères de SSc et prédisaient une détérioration de la fonction pulmonaire et une mortalité accrue à 10 ans.
Les récents résultats positifs de l'essai de phase 2 SPRING chez des patients atteints de PSC ont démontré l'efficacité de nebokitug dans la réduction des biomarqueurs fibro-inflammatoires, y compris le score ELF, PRO-C3, IL-6 et TGF-β, qui sont également des indicateurs de l'activité de la SSc.
Chemomab Therapeutics (Nasdaq: CMMB) hat auf der CORA 2025 neue Daten präsentiert, die das Potenzial von nebokitug (CM-101) als Behandlung für systemische Sklerose (SSc) unterstützen. Die Präsentation, die für den 8. März 2025 in Venedig, Italien, geplant ist, stellt nebokitug als erstklassigen monoklonalen Antikörper vor, der auf CCL24 abzielt, einen Schlüsselverursacher bei fibro-inflammatorischen Erkrankungen.
Die neue Studie, die mit Dr. Alexandra Balbir-Gurman durchgeführt wurde, analysierte Haut- und Serumproben von SSc-Patienten und zeigte die Rolle von CCL24 bei induzierter Fibrose und der Pathogenese von SSc. Eine 2024 veröffentlichte, von Fachleuten begutachtete Studie über mehr als 200 SSc-Patienten zeigte, dass höhere CCL24-Spiegel mit schweren Formen von SSc korrelierten und eine Verschlechterung der Lungenfunktion sowie eine höhere 10-Jahres-Mortalität vorhersagten.
Die jüngsten positiven Ergebnisse der Phase-2-Studie SPRING bei PSC-Patienten zeigten die Wirksamkeit von nebokitug bei der Reduzierung von fibro-inflammatorischen Biomarkern, einschließlich ELF-Score, PRO-C3, IL-6 und TGF-β, die ebenfalls Indikatoren für die Aktivität von SSc sind.
- Phase 2 SPRING trial showed positive results in reducing key biomarkers
- Strong correlation found between CCL24 levels and disease severity in 200+ patient study
- Open U.S. IND for Phase 2 trial in SSc
- First major clinical validation of dual anti-inflammatory and anti-fibrotic mechanism
- None.
Insights
The data presentation at CORA 2025 adds incremental scientific validation for Chemomab's lead candidate nebokitug (CM-101) in systemic sclerosis (SSc), but falls short of a major clinical milestone. The study identified specific immune cell populations with altered CCR3 expression linked to SSc, further supporting the scientific rationale for targeting CCL24.
This builds upon their previously reported positive Phase 2 SPRING trial in PSC patients, where nebokitug demonstrated reductions in key fibro-inflammatory biomarkers also relevant to SSc progression. The company now has an open U.S. IND for a Phase 2 trial in SSc, indicating they've cleared initial regulatory hurdles.
For context, SSc represents a significant commercial opportunity as a lethal autoimmune disease with no approved disease-modifying therapies. The 2024 publication linking CCL24 levels to disease severity and mortality provides compelling biomarker evidence, though this must eventually translate to clinical outcomes.
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Chemomab's data adds meaningful mechanistic insights into CCL24's role in systemic sclerosis pathogenesis. The collaboration with Dr. Balbir-Gurman, a respected scleroderma specialist, lends credibility to these findings that connect CCR3-expressing immune cell populations to SSc manifestations.
What's particularly notable is the translational coherence across multiple lines of evidence: the bleomycin mouse model, patient tissue samples, previous biomarker studies, and their successful PSC trial results. The 2024 publication showing that elevated CCL24 levels predict pulmonary function deterioration and higher mortality provides a compelling biomarker rationale.
Systemic sclerosis presents formidable development challenges due to its heterogeneity and multi-organ involvement. However, nebokitug's dual anti-inflammatory and anti-fibrotic mechanism demonstrated in PSC patients—reducing ELF score, PRO-C3, IL-6, and TGF-β—addresses key pathways in SSc pathology affecting skin, lungs, and vasculature.
The scientific case appears strong, particularly given CCL24's potential role in the most severe SSc phenotypes with irreversible tissue damage. However, translating these mechanisms into clinical efficacy remains the critical hurdle, as numerous promising approaches in SSc have faltered in late-stage development despite strong preclinical rationales.
Adds to Extensive Preclinical and Early Clinical Evidence that Nebokitug Interferes with Key Features
of Systemic Sclerosis
TEL AVIV, Israel, March 06, 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 a new scientific presentation that further confirms the potential of nebokitug (CM-101) as a novel treatment for systemic sclerosis (SSc).1 The data will be presented at the 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025) on March 8, 2025, in Venice, Italy.
Systemic sclerosis is an autoimmune disease characterized by microvascular injury and extensive tissue fibrosis of the skin and internal organs. It is the most lethal of the systemic connective tissue diseases and lacks approved disease-modifying therapies. Nebokitug is a first-in-class monoclonal antibody that blocks the soluble protein CCL24, which has been shown to be a key driver of the pathways underlying fibro-inflammatory conditions such as SSc and primary sclerosing cholangitis (PSC). In extensive preclinical studies, blocking CCL24 reduced the inflammatory and fibrotic injury to the lung, skin and vasculature that are hallmarks of SSc pathology. An investigator-sponsored study showed that treatment with nebokitug induced strong and rapid reductions in inflammatory biomarkers in patients with acute lung Injury, a relevant model for the type of lung damage seen in SSc patients.
“This new data adds to the extensive body of preclinical evidence that CCL24 is a key driver of the skin, lung and vascular manifestations of this disabling condition that lacks disease-modifying therapies,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “These results further reinforce our belief, based on multiple preclinical and patient sample studies and the positive results from our Phase 2 PSC trial, that nebokitug has substantial potential as a treatment for SSc. Chemomab has an open U.S. IND for a Phase 2 trial of nebokitug in SSc.”
The new study being presented at CORA 2025 was conducted in collaboration with Dr. Alexandra Balbir-Gurman, former director of the B. Shine Rheumatology Institute at Rambam Health Care Campus, Clinical Associate Professor at the Rappaport Faculty of Medicine of the Technion-Israel Institute of Technology and a noted scleroderma researcher and clinician. The study used matching skin and serum samples from a large registry of SSc patients and data from the bleomycin-mouse model to assess nebokitug’s possible effects on CCR3-expressing immune cells in SSc (CCR3 is the receptor for CCL24). Researchers analyzed CCL24’s role in induced fibrosis and SSc pathogenesis and identified several peripheral immune cell populations with altered expression of CCR3, two of which are linked to SSc and its complications. These findings further underscore the role of CCL24 in SSc and strengthen the therapeutic rationale for targeting CCL24 inhibition with nebokitug as a potential SSc therapy.
A 2024 peer-reviewed publication2 found strong associations between nebokitug’s CCL24 target and SSc. Data from more than 200 SSc patients showed that higher CCL24 levels were linked to clinical variables associated with the most severe forms of SSc with irreversible tissue damage, including severity of skin fibrosis and calcinosis, presence of interstitial lung disease and a history of digital ulcers and synovitis. Importantly, high serum CCL24 was predictive for deterioration of pulmonary function and a higher baseline CCL24 level was associated with higher 10-year SSc-related mortality.
Recent positive data from the nebokitug Phase 2 SPRING trial in patients with PSC further strengthens the rationale for assessing nebokitug in SSc. This trial was the first major clinical validation of the dual anti-inflammatory and anti-fibrotic mechanism of nebokitug. In patients with PSC, nebokitug reduced fibro-inflammatory biomarkers including the enhanced liver fibrosis (ELF) score, PRO-C3, Interleukine-6 (IL-6) and transforming growth factor beta (TGF-β), all of which are well-established indicators of SSc fibrosis and disease activity.
CORA 2025 Session: 0680 - Poster Session 10: SLE, ILD and Novel Therapeutic Targets
Date/Time: Saturday, March 8, 2025, 10:30 - 11:30 CET
Room: Station 02
The CORA 25 poster will also be available at the R&D section of www.chemomab.com.
About Nebokitug (CM-101)
Nebokitug is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. By inhibiting CCL24, nebokitug blocks both immune cell recruitment and fibroblast activation, thereby interrupting the self-reinforcing cycle that results in fibrosis. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile, 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, including the Phase 2 SPRING trial in patients with PSC. This study achieved the primary safety endpoint and nebokitug-treated patients with moderate to advanced disease showed improvements on a wide range of disease-related secondary endpoints. The open label extension portion of the SPRING trial is continuing, with results expected in the first quarter of 2025. Nebokitug is also being developed for systemic sclerosis and the SSc program has an open U.S. IND. Nebokitug has received FDA and EMA Orphan Drug designations for the treatment of PSC and SSc and FDA Fast Track status for the treatment of PSC in adults.
About Systemic Sclerosis
Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune rheumatic disease characterized by fibrosis and inflammation of the skin, joints and internal organs, along with vascular abnormalities. It predominantly affects women and is typically diagnosed when patients are between 30 and 50 years old. It is considered the most devastating condition among systemic rheumatic diseases with severe morbidity and high mortality, with a median survival of only 10 years. There is no approved disease-modifying drug for the disease. Current estimates from the Scleroderma Foundation suggest there are approximately 100,000 SSc patients in the U.S.
1. CCL24 Expression and Impact on Immune Cell Populations in Systemic Sclerosis, R. Greenman, A. Katav, I. Vaknin, T. Snir, V. Shataylo, A. Balbir-Gurman. The 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025) , March 8, 2025
2. Serum CCL24 as a biomarker of fibrotic and vascular disease severity in Systemic Sclerosis, E. De Lorenzis, A. Mor, R.L. Ross, S. Di Donato, R. Aricha, I. Vaknin, F. Del Galdo. Arthritis Care & Research, https://doi.org/10.1002/acr.25344
Forward-Looking Statements
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 presentation 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, 2023. 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 recent positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a PSC nebokitug Phase 3 trial. The design calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential regulatory approval. Data from the SPRING trial open label extension will be reported in the first quarter of 2025. 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.
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
FAQ
What are the key findings of Chemomab's (CMMB) nebokitug presentation at CORA 2025?
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