Chemomab Therapeutics Ltd. · NASDAQ:CMMB
Chemomab Therapeutics — DDW 2025
25 slides from Chemomab Therapeutics's conference presentation, May 4, 2025
Slide 1: Nebokitug SPRING Study in Primary Sclerosing Cholangitis
Nebokitug (CM-101), a novel monoclonal antibody targeting CCL24, was safe and well tolerated and showed improvements of biomarkers associated with inflammation, fibrosis, and cholestasis in patients with primary sclerosing cholangitis: The SPRING Study CL Bowlus1, ST Barclay2, D Joshi3, MC Londoño4,
Slide 2: PSC is a Rare Cholestatic Liver Disease with High Unmet Needs
Primary Sclerosing Cholangitis (PSC) is a Rare Cholestatic Liver Disease with High Unmet Needs • Unknown etiology but associated with inflammatory bowel disease in ~70% • Characterized by inflammation and fibrotic strictures of the bile ducts • Complications include cirrhosis, cholangitis, and chola
Slide 3: CCL24 Promotes Cell Trafficking and Regulates Inflammatory and Fibrotic Activities
CCL24 is a Chemokine that Promotes Cell Trafficking and Regulates Inflammatory and Fibrotic Activities through the CCR3 Receptor CCL24 Secreting Cells Immune and CCL24 Epithelial The Cells Target CCR3 CCL24 – CCR3 promotes Causing more CCL24 The CCL24 inflammation and fibrosis inflammation Regulated
Slide 4: CCL24 Levels are Elevated in PSC Patients and Associated with Cirrhosis
Background: CCL24 Levels are Elevated in PSC Patients and Associated with Cirrhosis CCL24 levels in liver tissue of healthy subjects Serum CCL24 level was higher in vs. patients with PSC1 patients with cirrhosis2 Healthy Liver PSC Livers CCL24 Staining CCL24 (brown) CCL24 (red) overexpressed overexp
Slide 5: Methods: SPRING Study Design
Methods: SPRING Study Design Phase 2, randomized, double-blind, placebo-controlled study of Nebokitug in PSC Key Enrollment Criteria SPRING Study (NCT 04595825) PSC patients with large duct disease of >24 weeks duration • ALP > 1.5 ULN • Stable IBD allowed • Stable UDCA treatment allowed Outcome Mea
Slide 6: Patient Disposition
Patient Disposition Patient Enrolled N=134 Screen failure N=57 Randomized N=77 Placebo Nebokitug 10mg/kg Nebokitug 20 mg/kg Intent-to-treat Intent-to-treat Intent-to-treat N=21 N=25 N=31 Safety Population Safety Population Safety Population N=20 N=25 N=31 Early Discontinuation (n=2) Early Discontinu
Slide 7: Patient Demographics and Baseline Characteristics
Results: Patient Demographics and Baseline Characteristics (Safety Population) Characteristic Placebo Nebokitug (10 mg/kg) Nebokitug (20 mg/kg) n=20 n=25 n=31 Age (year), mean, (range) 40.5 (23–75) 48.6 (23–74) 45.6 (23–67) Male Gender, n, (%) 13 (65%) 16 (64%) 17 (55%) Race, n, (%) White 19 (95%) 1
Slide 8: Safety and Tolerability Profile
Results: Safety and Tolerability Profile Treatment Emergent Adverse Events Nebokitug Nebokitug Nebokitug N, (%) Placebo 10mg/kg 20mg/kg All n=20 n=25 n=31 n=56 Treatment Emergent Adverse Events (TEAE) 15 (75%) 18 (72%) 28 (90%) 46 (82%) Related to study drug 9 (45%) 7 (28%) 16 (52%) 23 (41%) Serious
Slide 9: Most Common Treatment Emergent Adverse Events
Results: Most Common Treatment Emergent Adverse Events Placebo Nebokitug Nebokitug Nebokitug Treatment Emergent Adverse Events, n (%) 10mg/kg 20mg/kg All ≥10% Frequency n=20 n=25 n=31 n=56 Fatigue 6 (30%) 5 (20%) 11 (36%) 16 (29%) Headache 4 (20%) 2 (8%) 7 (23%) 9 (16%) Pruritis 2 (10%) 4 (16%) 2 (7
Slide 10: Liver Blood Tests
Results: Liver Blood Tests Patients with baseline All patients moderate/advanced disease* 39.2 40 20 16.5 Median % change from Median % change from baseline at week 15 baseline at week 15 10.4 10 19.3 20 5.0 13.8 2.9 10.4 0.3 0 4.9 3.5 3.6 2.8 -2.5 -1.4 -1.7 -5.2 0 -10 -7.2 -2.1 -9.6 -5.2 -8.7 -10.3
Slide 11: Total Bilirubin
Results: Total Bilirubin Patients with baseline All patients moderate/advanced disease* 0 0 0 0 Median % change from Median % change from baseline at week 15 baseline at week 15 -5 -5 -10 -9.2 -8.9 -10 -10.7 p=0.07 -13.3 -15 Placebo 10mg/kg 20mg/kg Placebo 10mg/kg 20mg/kg n=16 n=22 n=28 n=7 n=14 n=1
Slide 12: ELF Scores
Results: ELF Scores All patients Patients with baseline moderate/advanced disease* 0.8 0.8 Placebo Placebo 10 mg/kg 10 mg/kg 0.6 0.6 20 mg/kg 20 mg/kg change from baseline change from baseline 0.4 0.4 0.28 LS mean (SE) LS mean (SE) 0.2 0.21 0.2 0.0 0.0 -0.2 -0.13 -0.2 -0.4 -0.4 Baseline 3 6 9 12 15
Slide 13: Liver Stiffness Measurements
Results: Liver Stiffness Measurements Patients with baseline All patients moderate/advanced disease* p=0.12 p=0.16 * p=0.01 2 6 * p=0.01 change from baseline to week 15 change from baseline at week 15 1 4 1.04 LS mean (SE) LS mean (SE) 3.0 2 0 -0.72 -0.83 0 -1 -1.5 -1.4 -2 -2 Placebo 10mg/kg 20mg/kg
Slide 14: 5-D ITCH Total Scores
Results: 5-D ITCH Total Scores Nebokitug-treated patients experienced decreased pruritus scores across all timepoints compared to placebo *Pruritis assessments based on 5D Itch Score-Total Domain; DBC population CHEMOMAB THERAPEUTICS 14
Slide 15: Responder Analysis
Results: Responder Analysis Response was defined as any reduction in LSM, PRO-C3, and less than 0.19 increase in ELF score All patients Patients with baseline moderate/advanced disease* 40 36.0 60 50.0 30 % Responders % Responders 40 20.0 20 14.3 21.4 20 10 0 0 0 Placebo 10 mg/kg 20 mg/kg Placebo 10
Slide 16: Summary of Findings from Double-Blind Period of the SPRING Study
Summary of Findings from Double-Blind Period of the SPRING Study • 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 • In a pre-specified subgroup of
Slide 17: SPRING Study – Open Label Extension
SPRING Study – Open Label Extension 17
Slide 18: SPRING Study: Open-label Design and Endpoints
SPRING Study: Open-label Design and Endpoints 93% of eligible patients elected to continue to Open Label Extension (OLE) Nebokitug SPRING Trial • Data from 48-weeks of nebokitug treatment were used to evaluate: – Long term safety Nebokitug 10 mg/kg IV Q3W – Durability of anti-fibrotic Patients effec
Slide 19: Safety and Tolerability – OLE Period
Results: Safety and Tolerability – OLE Period Placebo to Placebo to Nebokitug Nebokitug Treatment Emergent Adverse Events Nebokitug Nebokitug 10mg/kg 20mg/kg N, (%) 10mg/kg 20mg/kg n=11 n=27 n=1 n=11 Total 33 weeks exposure Total 48 weeks exposure Treatment Emergent Adverse Events (TEAE) 1 (100%) 9
Slide 20: Safety and Tolerability – OLE Period
Results: Safety and Tolerability – OLE Period Placebo to Placebo to Nebokitug Nebokitug Treatment Emergent Adverse Events, n (%) Nebokitug Nebokitug 10mg/kg 20mg/kg ≥10% Frequency 10mg/kg 20mg/kg n=11 n=27 n=1 n=11 Total 33 weeks exposure Total 48 weeks exposure Fatigue 0 1 (9.1%) 1 (9.1%) 8 (29.6%)
Slide 21: ELF Scores – OLE Period
Results: ELF Scores – OLE Period All patients Moderate/advanced patients 10 mg/kg (n=8) 10 mg/kg n=4 20 mg/kg (n=21) 20 mg/kg n=10 change from baseline Mean (SE) ELF score 0.5 change from baseline Mean (SE) ELF score 0.5 0.0 0.0 -0.5 -0.5 Baseline 15 30 48 0 15 30 48 Week Week Continual reduction in
Slide 22: Liver Stiffness Measurements – OLE Period
Results: Liver Stiffness Measurements – OLE Period All patients Moderate/ advanced patients change from baseline [kPa/year] 3 change from baseline [kPa/year] 3 Mean (SE) LSM Mean (SE) LSM 2 2 1 1 0 0 10mg/kg 20mg/kg All nebokitug Historical 10mg/kg 20mg/kg All nebokitug Historical n=7 n=22 n=29 Data
Slide 23: Key Findings from the Open-Label Extension Period
Key Findings from the Open-Label Extension Period of the SPRING study • Safe and well-tolerated for up to 48 weeks of treatment • Showed sustained or continual improvement in markers of fibrosis – Sustained and continual reduction in ELF score, especially in patients with moderate/advanced disease r
Slide 24: Acknowledgements
Acknowledgements • We thank the patients, their families, caregivers, the study investigator and research coordinators who participated in this study • Enrolling Spring Study Investigators: Sayed Assem (US) Stephen T Barclay (UK) Nimer Assy (Israel) Udi Zigmond (Israel) Justin Boike (US) Chenchu Ram
Slide 25: Thank You
Thank You CHEMOMAB THERAPEUTICS 25