Chemomab Therapeutics Ltd. · NASDAQ:CMMB
Chemomab Therapeutics — Technical Presentation (July 2024)
20 slides from Chemomab Therapeutics's technical presentation, Jul 25, 2024
Slide 1: CM-101 Phase 2 SPRING Trial Preliminary Topline Results
CM-101 Phase 2 SPRING TRIALPreliminary Topline Results JULY 25, 2024 NASDAQ: CMMB
Slide 2: Forward-looking statements
This presentation 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 presentation,
Slide 3: SPRING Trial: Positive Results Support Advancing CM-101 in PSC
Clinical proof-of concept established Achieved primary and secondary exploratory efficacy endpoints across anti-inflammatory, anti-fibrotic and anti-cholestatic elements of PSC Achieved statistically significant improvement in Liver Stiffness measurement (FibroScan®) Reduced pruritis (itch) across a
Slide 4: PSC Has High Unmet Need & Large Commercial Potential
Primarily affects men in their 40’s Symptoms include fatigue, pruritis, abdominal pain and jaundice Diagnosed via serum liver enzyme abnormalities, cholangiography Unknown cause; associated with IBD in ~70% of patients 50% of patients require liver transplantation; PSC re-occurs in ~20% of recipient
Slide 5: Phase 2 PSC SPRING Trial Design and Endpoints
CM-101 Primary Sclerosing Cholangitis SPRING Trial Key Enrollment Criteria PSC patients with large duct disease of >24 weeks duration ALP > 1.5 ULN Stable IBD allowed Stable UDCA treatment allowed Outcome Measures Primary – Safety and tolerability Secondary - Change from baseline to Week 15 in: Live
Slide 6: SPRING Trial Patient Disposition
SPRING Trial Patient Disposition *Double Blind Completer = Received all (5) doses & had baseline assessments for ELF and ALP Randomized and Treated N=76 CM-101 (10 mg/kg & 20 mg/kg) Double Blind Completers n=502 Double Blind Completers* n=161 Safety Population n=20 Safety Population n= 56 Placebo 1-
Slide 7: SPRING Trial Patient Demographics (Safety Population)
Characteristic Placebo n=20 CM-101 10 mg/kg n=25 CM-101 20 mg/kg n=31 CM-101 (All) n=56 Age (year), mean, (range) 40.5 (23–75) 48.6 (23–74) 45.6 (23–67) 46.9 (23–74) Male Gender, n, (%) 13 (65%) 16 (64%) 17 (55%) 33 (59%) Race, n, (%) White Black Asian Multiple/ not reported/ unknown 19 (95%) 1 (5%)
Slide 8: SPRING Trial Baseline Characteristics (Safety Population)
Serum Liver Function Tests mean, (SD) Placebo n=20 CM-101 10 mg/kg n=25 CM-101 20 mg/kg n=31 CM-101 (All) n=56 Alkaline Phosphatase (U/L) 355 (203) 333 (189) 325 (167) 329 (176) Alanine Aminotransferase (U/L) 121 (83) 91 (63) 83 (51) 86 (56) Aspartate Aminotransferase (U/L) 87 (54) 59 (27) 64 (31) 6
Slide 9: CM-101 Demonstrated Favorable Safety & Tolerability Profile
Treatment Emergent Adverse Events N, (%) Placebo n=20 CM-101 10mg/kg n=25 CM-101 20mg/kg n=31 CM-101 (All) 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 TEAE 1 (5%) 2 (8%) 0 (0) 2 (4%) Related to stud
Slide 10: SPRING Trial: Adverse Events by Type
Treatment Emergent Adverse Events, n (%) ≥10% Frequency Placebo n=20 CM-101 10mg/kg n=25 CM-101 20mg/kg n=31 CM-101 (All) 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%) 6 (11%) Infusion site pain 3 (15%) 2 (8%) 1 (3%) 3 (5%) Uri
Slide 11: Biological Activity Observed Across Multiple Parameters
SPRING Trial Data: Biological Activity Observed Across Multiple Parameters 11
Slide 12: SPRING Trial: Pharmacokinetics (PK) Profile
12 SPRING Trial: Pharmacokinetics (PK) Profile Over 15 weeks CM-101 data shows favorable & dose dependent pharmacokinetics in patients with PSC a Dose-dependent target engagement was also observed, reflecting strong antibody-ligand binding
Slide 13: Liver Stiffness Measures Improved in CM-101-Treated Patients
13 SPRING Trial: Liver Stiffness Measures Improved in CM-101-Treated Patients *VCTE>8.7 kPa; 1Chazouillèreset al, EASL 2024 Significantly improved liver stiffness observed with CM-101 compared to placebo in patients with moderate/advanced disease All patients Patients with baseline moderate/advance
Slide 14: ELF Scores Improved in Patients with Moderate/Advanced Disease
14 SPRING Trial: ELF Scores Improved in CM-101 Patients with Moderate/Advanced Disease Treated with 20 mg/kg Dose ELF scores relative to placebo reduced at all time points *VCTE>8.7 kPa; 1 Muir et al , 2019 In patients treated with 20 mg/kg of CM-101, changes in baseline ELF score remained consisten
Slide 15: PRO-C3 Improved in CM-101-Treated Patients
15 SPRING Trial: PRO-C3 Improved in CM-101-Treated Patients with Moderate/Advanced Disease Reduced PRO-C3 at week 15 relative to placebo observed for both 10 mg/kg & 20 mg/kg doses PROC-C3: neo-epitope pro-peptide of type III collagen formation. *VCTE>8.7 kPa; 1-Nielsen et al, 2018 Patients with bas
Slide 16: Pruritis Scores Improved in CM-101-Treated Patients
16 SPRING Trial: Pruritis Scores* Improved in CM-101-Treated Patients *Pruritis assessments based on 5D Itch Score-Total Domain; DBC population CM-101-treated patients experienced decreased pruritis scores across all timepoints compared to placebo
Slide 17: Total Bilirubin Improved in CM-101-Treated Patients
17 SPRING Trial: Total Bilirubin Improved in CM-101-Treated Patients Total bilirubin is an indicator of bile duct health Dose-dependent improvement supports the anti-cholestatic activity of CM-101 Patients with baseline moderate/advanced disease* *VCTE>8.7 kPa All patients
Slide 18: Liver Function Tests Improved in CM-101-Treated Patients
18 SPRING Trial: Liver Function Tests Improved in CM-101-Treated Patients Key liver function tests all improved in CM-101-treated patients Patients with baseline moderate/advanced disease* All patients *VCTE>8.7 kPa
Slide 19: Inflammatory Cytokines Reduced in CM-101-Treated Patients
19 SPRING Trial: Inflammatory Cytokines Reduced in CM-101-Treated Patients with Moderate/Advanced Disease* IL-6 TGFb1 In patients with moderate/advanced disease receiving the 20mg/kg dose, CM-101 significantly reduced levels of IL-6 & TGF1, which play an important role in inflammation & fibrosis *V
Slide 20: SPRING Trial: Positive Results Support Advancing CM-101 in PSC
Clinical proof-of concept established Achieved primary and secondary exploratory efficacy endpoints across anti-inflammatory, anti-fibrotic and anti-cholestatic elements of PSC Achieved statistically significant improvement in Liver Stiffness measurement (FibroScan®) Reduced pruritis (itch) across a
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