nebokitug intravenous (CM-101 intravenous) / ChemomAb - LARVOL DELTA

Chemomab Therapeutics Announces Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Nebokitug PSC Phase 3 Design Near Completion Following Positive FDA Feedback...Regulatory Alignment Advances, with EMA Guidance Supporting a Single Nebokitug Phase 3 Registration Trial Using a Clinical Event Composite Endpoint,"

New P3 trial • Inflammation

Nebokitug, an anti-CCL24 monoclonal antibody, in patients with primary sclerosing cholangitis: A phase 2 study. (PubMed, Am J Gastroenterol) - "Nebokitug was well-tolerated up to 48 weeks of treatment, and demonstrated numerical biomarker improvements in patients with PSC, particularly in those with moderate/advanced fibrosis."

Clinical • Journal • P2 data • Fibrosis • Immunology • Liver Cirrhosis

NEBOKITUG TARGETS MACROPHAGE-MEDIATED MECHANISMS IN PRIMARY SCLEROSING CHOLANGITIS WITH POTENTIAL IMPACT ON DISEASE PROGRESSION (AASLD 2025) - P2 | "Nebokitug modulates key macrophage-related biomarkers in patients with PSC that have been shown to correlate with disease progression. These data suggest a potential role for nebokitug in modifying disease biology and support continued clinical evaluation."

Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • CD14 • MRC1 • MST1 • SPP1

TARGETING CCL24 RESTORES MST1 EXPRESSION: A MECHANISTIC INSIGHT FROM THE SPRING TRIAL (AASLD 2025) - P2 | "Nebokitug treatment in PSC patients leads to a significant dose-dependent increase in MST1, correlating with CCL24 target engagement and reduction in LSM. These results from the SPRING trial suggest that MST1 may serve as a PD biomarker of nebokitug activity and further support its anti-inflammatory mechanism of action."

Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • ABCB4 • MST1

CM101, a novel monoclonal antibody targeting CCL24, in patients with primary sclerosing cholangitis: results from spring study (BSG 2025) - "CM-101 exhibited anti-fibrotic, anti-inflammatory and anti-cholestatic activity in patients with PSC after 15 weeks of treatment. Data from this phase 2 study supports the evaluation of CM-101 in a phase 3 study in patients with PSC."

Clinical • Dermatology • Fatigue • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Pain • Pruritus • CXCL8 • IL6 • PRO-C3 • TGFB1

Chemomab Announces Oral Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis at BSG Live’25 (GlobeNewswire) - P2 | N=68 | SPRING (NCT04595825) | Sponsor: ChemomAb Ltd. | "The BSG Live’25 session presented data from the double-blind, placebo-controlled portion of the SPRING trial showing that nebokitug was well-tolerated and had a safety profile comparable to placebo over 15 weeks of treatment in patients with PSC, and it demonstrated dose dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects. In a prespecified subgroup of patients with moderate to advanced disease, patients treated with nebokitug showed broad and consistent improvement in biomarkers that are associated with better clinical outcomes in PSC...The presentation also noted that data from the open label extension portion of the trial, in which all eligible participants received nebokitug for up to an additional 33 weeks, showed that nebokitug was safe and well-tolerated for up to 48 weeks of treatment. Patients treated with nebokitug showed sustained improvement in markers of fibrosis..."

P2 data • Inflammation

Chemomab Reports Positive Feedback From Two Recent FDA Meetings Supporting Phase 3 Advancement of Nebokitug in Primary Sclerosing Cholangitis (GlobeNewswire) - "Chemomab Therapeutics Ltd...reported that it has obtained confirmation from the FDA on two significant development milestones as the company continues to finalize the nebokitug Phase 3 program. As part of the FDA End-of-Phase 2 (EOP2) review process, Chemomab and the FDA addressed multiple Chemistry, Manufacturing, and Controls (CMC) topics critical to ensuring the quality and consistency of drug supply for the late-stage development and eventual commercialization of nebokitug. Chemomab also engaged in a Type C meeting with the FDA to address the non-clinical fetal and embryo developmental toxicology studies that are part of the new drug regulatory pathway. Importantly, the FDA agreed that this toxicology testing may be conducted in parallel with the nebokitug Phase 3 clinical trial and be submitted as part of the planned Biologics Licensing Application (BLA)."

FDA event • Immunology • Primary Biliary Cholangitis

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 (GlobeNewswire) - "Chemomab Therapeutics, Ltd...announced that its lead product nebokitug (formerly CM-101) has been awarded new patent protections in China and Russia....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."

Patent • Primary Biliary Cholangitis

Chemomab Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Reported Positive 48-Week Data from SPRING Trial-Nebokitug Treatment in PSC Patients with Moderate/Advanced Disease Resulted in Continued Improvements across Key Biomarkers of Liver Injury, Inflammation and Fibrosis; Aligned with FDA on Pathway to Potential Regulatory Approval for the Treatment of PSC with a Single, Clinical-Events-Driven Clinical Trial; These Major Milestones Support the Advancement of Nebokitug to Phase 3 and Position It to Potentially Become the First FDA-Approved Treatment for PSC; Cash Runway Extended to the Second Quarter of 2026"

Commercial • P2 data • Primary Biliary Cholangitis

Chemomab Announces Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis in Distinguished Plenary Session at DDW 2025 (GlobeNewswire) - P2 | N=68 | SPRING (NCT04595825) | Sponsor: ChemomAb Ltd. | "The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period showing that nebokitug was well-tolerated and had a safety profile comparable to placebo. Nebokitug demonstrated dose dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects in patients with PSC....The presentation also included data from the open label extension portion of the study, in which all eligible study patients received nebokitug for up to an additional 33 weeks. This data showed that nebokitug was safe and well-tolerated for up to 48 weeks of treatment....We are pleased that these positive data were featured at a major multi-disciplinary medical meeting like DDW 2025, as we continue to assess the best options for advancing nebokitug to a Phase 3 trial."

P2 data • Hepatology

Chemomab Reports New Positive Clinical Data at EASL 2025 Supporting Nebokitug’s Impact in Primary Sclerosing Cholangitis and Related Diseases (GlobeNewswire) - P2 | N=68 | SPRING (NCT04595825) | Sponsor: ChemomAb Ltd. | "New Analyses of PSC Data from Phase 2 SPRING Trial Show that Treatment with Nebokitug Is Associated with Dose-Dependent and Significant Improvements in Multiple Inflammatory and Fibrotic Biomarkers; Further Confirms the Clinical Potential of Nebokitug As a First-in-Class Novel Treatment for PSC and Other Fibro-Inflammatory Conditions; Second EASL 2025 Poster Reports that Pharmacokinetic and Pharmacodynamic Data from the Phase 2 Spring Trial Demonstrates Effective and Dose-Dependent Antibody-Target Engagement."

P2 data • Hepatology

CM-101 impacts disease biomarkers in primary sclerosing cholangitis: assessment of the SPRING study pharmacokinetics and pharmacodynamics (EASL 2025) - "CM-101 demonstrates two-compartment, dose-dependent PK with high target engagement in patients with PSC. A dose-dependent trend between the higher dose and reductions in TE and ALP is encouraging. Additional data is expected following a planned phase 3."

Biomarker • PK/PD data • Hepatology

Chemomab Therapeutics to Present Nebokitug Clinical Data at Upcoming Scientific Conferences (GlobeNewswire) - "Chemomab Therapeutics, Ltd...today announced that clinical data on nebokitug (CM-101) for the treatment of patients with primary sclerosing cholangitis (PSC) will be presented at major upcoming scientific conferences including DDW25, Digestive Disease Week 2025; EASL 2025, the Annual Congress of the European Association for the Study of the Liver; and BSG LIVE'25, the British Society of Gastroenterology’s annual meeting."

Clinical data • Hepatology

Chemomab Reports Positive Results in Nebokitug Phase 2 PSC Open Label Extension Trial Showing Continued Broad and Substantial Improvements in Key Liver Biomarkers (GlobeNewswire) - P2a | N=68 | SPRING (NCT04595825) | Sponsor: ChemomAb Ltd. | "The OLE study confirmed that the drug was safe and well-tolerated in PSC patients receiving 10 mg/kg or 20 mg/kg of nebokitug administered once every three weeks for up to 48 weeks, and resulted in positive effects, including continued improvements in key liver biomarkers such as the ELF score, the fibrosis-related components of ELF and the fibrosis biomarker PRO-C3. Liver stiffness scores (transient elastography), as measured by FibroScan were substantially lower in the nebokitug-treated patients with moderate/advanced disease compared to matching historical controls...OLE patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events (4.8%) compared to matching historical controls (25.8%)....'These findings reinforce nebokitug’s potential to alter the course of PSC, as well as the rationale for the planned Phase 3 trial..."

New P3 trial • P2 data • Immunology

New Data Presented at CORA 2025 Conference Highlights Clinical Potential of Chemomab’s Nebokitug in Systemic Sclerosis (GlobeNewswire) - "Chemomab Therapeutics, Ltd...today announced a new scientific presentation that further confirms the potential of nebokitug (CM-101) as a novel treatment for systemic sclerosis (SSc). 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...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."

Preclinical • Immunology • Systemic Sclerosis

Chemomab Completes Successful End-of-Phase 2 Meeting and Aligns with FDA on Clear and Efficient Path to Potential Regulatory Approval for Nebokitug (CM-101) in Primary Sclerosing Cholangitis (GlobeNewswire) - "Chemomab Therapeutics Ltd...today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with FDA on the design of a single Phase 3 registration study for its lead product candidate nebokitug (CM-101) for the treatment of primary sclerosing cholangitis (PSC). Nebokitug is the drug name recently assigned to CM-101 by the International Nonproprietary Names (INN) program of the World Health Organization...'We are looking forward to reporting topline data from the open label extension portion of the SPRING trial, which is primarily intended to provide additional data on nebokitug’s long term safety, before the end of the first quarter. The company is currently in active discussions with potential strategic partners while laying the groundwork for the Phase 3 program, which we could potentially launch before the end of the year.'"

FDA event • New P3 trial • P2 data • Immunology • Inflammation

Chemomab Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "'We are on track to complete two important milestones in the first quarter of 2025—first, agreement with the FDA on the design of a PSC pivotal trial for CM-101 and second, reporting new clinical data from the open label portion of the Phase 2 SPRING trial. We will be meeting with the FDA before the end of this year to discuss the design of a CM-101 registrational trial in patients with PSC.'"

FDA event • P1/2 data • Primary Biliary Cholangitis

Chemomab Therapeutics Announces Late-Breaking Oral Presentation of CM-101 Phase 2 Results in Primary Sclerosing Cholangitis at AASLD The Liver Meeting 2024 (GlobeNewswire) - "Chemomab Therapeutics Ltd...announced that its late breaking abstract discussing the results of the Phase 2 SPRING trial in primary sclerosing cholangitis (PSC) has been selected for an oral presentation at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting 2024. The conference will take place in San Diego, California, November 15 – 19, 2024....will give an oral presentation describing data from the double-blinded portion of the Phase 2 SPRING trial assessing CM-101 in individuals with PSC."

Late-breaking abstract • P2 data • Immunology • Primary Biliary Cholangitis

Chemomab Therapeutics Announces Positive Phase 2 Trial Results: CM-101 Achieves Primary and Secondary Endpoints Demonstrating Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in Patients with Primary Sclerosing Cholangitis (GlobeNewswire) - P2 | N=68 | SPRING (NCT04595825) | Sponsor: Chemomab Ltd | "Chemomab Therapeutics Ltd...today reported positive topline results from the Phase 2 SPRING trial assessing its first-in-class monoclonal antibody, CM-101...'We believe these results provide strong support for advancing CM-101 to a Phase 3 PSC trial, which we are planning to initiate in 2025 after our interactions with the FDA later this year.'...CM-101 met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period. CM-101-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness; in liver fibrosis biomarkers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritis (itch) and in markers of inflammation."

P2 data • Immunology • Inflammation

Chemomab Therapeutics Announces $10 Million Private Placement (GlobeNewswire) - "Chemomab Therapeutics Ltd...today announced that it has entered into a securities purchase agreement for a private investment in public equity ('PIPE') that is expected to result in gross proceeds of approximately $10 million to the Company, before deducting capital market advisor fees and offering expenses...Chemomab expects that the net proceeds from the PIPE will extend its cash runway to fund its operations through the beginning of 2026, an extension of approximately one year from current projections, which should fund the Company for approximately one year after the completion of two major milestones expected in early 2025...The Company intends to use the net proceeds from the PIPE, together with the Company's existing cash and cash equivalents, to fund its development programs for CM-101, and for general corporate purposes and working capital."

Financing • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Systemic Sclerosis

Chemomab Therapeutics Presents Data Supporting the Clinical Potential of CM-101 as a Novel Treatment for Primary Sclerosing Cholangitis at EASL 2024 and a Gordon Research Conference (GlobeNewswire) - "In a second poster, 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."

Clinical data • Immunology • Inflammation

Chemomab Therapeutics Presents Data Supporting the Clinical Potential of CM-101 as a Novel Treatment for Primary Sclerosing Cholangitis at EASL 2024 and a Gordon Research Conference (GlobeNewswire) - "Chemomab Therapeutics...reported that it presented two scientific posters supporting the clinical rationale for the company’s primary sclerosing cholangitis (PSC) program at EASL 2024...Chemomab also announced a poster presentation at the Gordon Research Conference on Chemotactic Cytokines, held June 2-7, 2024...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...The Gordon Conference presentation 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..."

Preclinical • Immunology • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis

Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies. (PubMed, Drug Saf) - P1, P1b | "In healthy volunteers and patients with MASLD without evidence of MASH, IV and SC CM-101 was well tolerated at doses ranging from 0.75 mg/kg to10.0 mg/kg and engaged its target (i.e., CCL24), indicating therapeutic potential in treating inflammatory and fibrotic diseases."

Journal • P1 data • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Scleroderma • Systemic Sclerosis

Chemomab Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "First Quarter 2024 Financial Highlights....R&D expenses were $3.1 million for the first quarter of 2024, compared to $6.9 million for the first quarter of 2023. The decrease in R&D expenses in the first quarter of 2024 compared to the first quarter of 2023 primarily resulted from the early completion of patient enrollment in the company’s CM-101 Phase 2 PSC trial."

Commercial • Immunology • Inflammation • Systemic Sclerosis

Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis (GlobeNewswire) - "Chemomab Therapeutics Ltd...reported that the European Patent Office has granted a new patent for CM-101...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....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."

P2 data • Patent • Trial status • Immunology • Primary Biliary Cholangitis