CM-101 intravenous / ChemomAb - LARVOL DELTA

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

Chemomab Therapeutics Announces Year End and Fourth Quarter 2023 Financial Results and Provides a Corporate Update (PRNewswire) - "Chemomab Therapeutics, Ltd...announced financial and operating results for the full year and fourth quarter ended December 31, 2023, and provided a corporate update...'Building on the positive data we have reported from our Phase 2a clinical trial in patients with liver fibrosis, we expect a successful readout would be a potential major catalyst for Chemomab, providing the first substantial clinical proof-of-concept for CM-101 and affording us the potential to advance to a registrational trial in consultation with the FDA, with an End-of-Phase 2 meeting possible later this year. We also look forward to a second readout from the trial's open label extension, expected in late 2024 or early 2025, which we believe will provide additional clinical data on longer-term safety and activity, as well as another potential catalyst.'....'We invite you to attend our upcoming webinar on...Expert Perspectives on Primary Sclerosing Cholangitis scheduled for April 10...'"

Clinical • FDA event • P2a data • Immunology • Inflammation • Inflammatory Bowel Disease

Chemomab Therapeutics Announces Year End and Fourth Quarter 2023 Financial Results and Provides a Corporate Update (PRNewswire) - "Full Year and Fourth Quarter 2023 Financial Highlights....R&D expenses were $3.1 million for the fourth quarter and $18.4 million for the full year ended December 31, 2023, compared to $5.9 million and $17.0 million for the respective periods in 2022. The decrease in R&D expenses in the fourth quarter of 2023 compared to the fourth quarter of 2022 figure primarily resulted from the early completion of patient enrollment in the company's CM-101 Phase 2 PSC trial."

Commercial • Immunology • Inflammation

Chemomab’s first-in class monoclonal antibody for fibro-inflammatory diseases, CM-101 receives Brazilian & Israel patents (Pharmabiz) - "Chemomab Therapeutics Ltd...announced that the Patent Offices in Brazil and Israel have granted new patents for CM-101...The Brazilian composition of matter Patent No. BR 11 2016 020366 6...includes claims broadly covering CM-101 and related anti-CCL24 antibodies per se and specifically for the treatment of fibrotic, inflammatory and autoimmune diseases. The grant of the patent was published January 2, 2024, with corresponding first to expire claims in 2035...Israeli Patent No. 269094....covers the use of CM-101 in the treatment of hepatic (liver) diseases, including PSC. It has a grant date of February 2, 2024, with corresponding first to expire claims in 2038. The new patent supplements existing Israeli CM-101 composition of matter and related patents."

Patent • Immunology • Primary Biliary Cholangitis

ABATE: Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=45 | Suspended | Sponsor: ChemomAb Ltd.

New P2 trial • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Chemomab Announces Completion of Patient Enrollment in CM-101 Phase 2 Primary Sclerosing Cholangitis Trial and Moves Up Expected Topline Readout to Midyear 2024 (PRNewswire) - "Chemomab Therapeutics Ltd...today announced early completion of patient enrollment in its Phase 2 clinical trial assessing CM-101 as a treatment for primary sclerosing cholangitis (PSC). The company also announced that it expects to report topline data from the PSC clinical trial by midyear 2024, rather than in the second half of 2024 as previously projected...Chemomab's Phase 2 SPRING trial (NCT04595825) is a double-blind, placebo-controlled, multiple dose study assessing the safety and tolerability of CM-101 administered to PSC patients with established large duct disease. The trial has completed enrollment of the planned 68 patients in the U.S., EU and Israel."

Enrollment closed • P2 data • Immunology • Metabolic Disorders

CM-101 in PSC Patients -The SPRING Study (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: ChemomAb Ltd. | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2

Enrollment closed • Phase classification • Hepatology

Chemomab Presentation at ACR Convergence 2023 Provides Further Support for Key Role of Its CCL24 Target in the Pathogenesis of Systemic Sclerosis (PRNewswire) - "Chemomab Therapeutics Ltd...today reported on its poster presentation at the American College of Rheumatology (ACR) Convergence 2023 conference...In this study, researchers analyzed whether CCL24 levels in SSc patients were associated with differences in functional measures such as the 6-minute walk test, as well as clinical manifestations of the disease such as the development of pulmonary arterial hypertension (PAH), a serious cardiovascular complication of SSc. They found that the average level of CCL24 in SSc patients with PAH was significantly higher compared to the level in SSc patients without PAH and that SSc patients with higher CCL24 levels had significantly lower scores on the 6-minute walk exercise capacity test than those with lower CCL24 levels....Notably, in cell-based assays, the addition of Chemomab's CCL24-neutralizing antibody CM-101 substantially mitigated these EndMT-related processes."

Clinical data • Preclinical • Immunology • Systemic Sclerosis

Chemomab Therapeutics Receives FDA Fast Track Designation for CM-101 for the Treatment of Primary Sclerosing Cholangitis (PRNewswire) - "Chemomab Therapeutics Ltd...announced that the U.S. Food and Drug Administration (FDA) has granted CM-101 Fast Track designation for the treatment in adult patients of primary sclerosing cholangitis (PSC), a fibrotic liver disease that can result in liver transplant, cancer and early death....Chemomab's Phase 2 SPRING trial (NCT04595825) is a double-blind, placebo-controlled study assessing the safety and tolerability of CM-101 in PSC patients....Patient enrollment in the trial is advancing towards completion and Chemomab anticipates reporting a top-line readout in the second half of 2024."

Fast track designation • P2 data • Immunology • Metabolic Disorders

Chemomab Therapeutics to Present Its CM-101 Clinical Program in Primary Sclerosing Cholangitis at 2023 Roth MKM Healthcare Opportunities Conference (PRNewswire) - "Chemomab Therapeutics Ltd...today announced that Chemomab co-founder, Chief Executive Officer and Chief Scientific Officer Adi Mor, PhD, will discuss the CM-101 clinical program in primary sclerosing cholangitis (PSC) at the 2023 Roth MKM Healthcare Opportunities Conference on October 12, 2023. The conference is being held at the Yale Club in New York City. Dr. Mor will give a live presentation at 12:00 noon ET and company executives will participate in one-on-one meetings with investors....CM-101 is currently being assessed in the Phase 2 SPRING trial for the treatment of PSC, with topline data expected in the second half of 2024."

P2 data • Inflammation

Boryung's equity investment, Chemomab, discontinues phase 2 systemic sclerosis pipeline 'CM-101' [Google translation] (News1 Korea) - "Chemomab Therapeutics, an Israeli biopharmaceutical company invested by Boryung, has started to improve its new drug pipeline to secure cash liquidity. Instead of suspending the phase 2 clinical trial for systemic sclerosis (SSC) indication for the new drug candidate 'CM-101', the company plans to focus on phase 2 clinical trial for patients with non-alcoholic steatohepatitis (NASH)....Chemomab announced that it does not plan to conduct phase 2 clinical trials for SSC indications for CM-101. This pipeline adjustment appears to be a strategy to secure cash liquidity. They announced that Chemomab will not enter phase 2 clinical trials for SSC indications and that they have secured cash liquidity that can be utilized until the fourth quarter of 2024."

Discontinued • Immunology • Systemic Sclerosis

The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects (clinicaltrials.gov) - P1b | N=16 | Completed | Sponsor: ChemomAb Ltd.

New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: ChemomAb Ltd.

New P1 trial • Fibrosis

Chemomab Therapeutics Announces Executive Leadership Changes and Provides a Corporate Update (PRNewswire) - "'Extensive preclinical studies in animal models and human tissue suggest that CM-101 may have therapeutic potential in systemic sclerosis (SSc); however, we are suspending initiation of the Phase 2 SSc trial in order to preserve capital. We plan to revisit the timing of study initiation going forward.'"

Trial suspension • Immunology • Systemic Sclerosis

Patient Data Presented at 2023 EULAR Congress Highlights How Serum CCL24 Levels Can Predict Vascular and Fibrotic Complications of Systemic Sclerosis (PRNewswire) - "Chemomab Therapeutics Ltd...announced a poster presentation at the 2023 European Congress of Rheumatology, hosted by the European Alliance of Association for Rheumatology (EULAR) and held in Milan, Italy May 31–June 3, 2023....Results from the study demonstrate that high serum concentration levels of the pro- fibrotic and pro-inflammatory cytokine CCL24 were correlated with SSc severity, including higher incidence of several measurable fibrosis-associated symptoms, a three-fold increased risk of interstitial lung disease (ILD) progression and a shorter 5-year SSc-related survival time."

Observational data • Immunology • Systemic Sclerosis

A PROOF OF BIOLOGICAL CONCEPT TRIAL OF CM101 TO TARGET CCL24 IN SYSTEMIC SCLEROSIS: A BIOMARKER INFORMED, PRECISION MEDICINE APPROACH (EULAR 2023) - "Conclusion This novel, biomarker enriched clinical trial, will determine the biological activity of CM101 in patients with active vascular or fibrotic SSc, across limited and cutaneous subsets, and inform future development of CM101 in SSc. Bridging biomarker science with clinical trial design carries the opportunity of improving the efficiency in subsequent clinical development and allows for a targetted treatment approach."

Biomarker • Dermatology • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CCR3 • CRP

CM-101 in PSC Patients -The SPRING Study (clinicaltrials.gov) - P2a | N=93 | Recruiting | Sponsor: ChemomAb Ltd. | N=45 ➔ 93 | Trial completion date: Sep 2022 ➔ Sep 2025 | Trial primary completion date: Jun 2022 ➔ Sep 2024

Enrollment change • Trial completion date • Trial primary completion date • Hepatology

Chemomab Announces FDA Clearance of Investigational New Drug Application for Phase 2 Clinical Trial of CM-101 in Patients with Systemic Sclerosis (PRNewswire) - "Chemomab Therapeutics, Ltd...today announced U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc)....The ABATE trial (a Phase 2, multicenter, randomized, double-blind, proof-of-biology study to evaluate the SAfety, ToleraBility, and Activity of CM-101 in Patients with SysTEmic Sclerosis) will enroll 45 patients with clinically active dermatologic, vascular or pulmonary SSc....The primary outcome measure is safety. Secondary endpoints include multiple serum-based biological markers and a variety of exploratory biological and clinical outcomes, including the American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score and its revisions (rCRISS)....A top-line data read-out is planned for the second half of 2024."

IND • New P2 trial • P2 data • Immunology • Systemic Sclerosis

CM-101: Top-line data from P2 trial for systemic sclerosis in Q4 2024 (Chemomab Therap) - Corporate Overview

P2 data • Systemic Sclerosis

Chemomab Therapeutics (CMMB) Reports Independent Drug Monitoring Committee Safety Review of CM-101 Phase 2 Trial in Primary Sclerosing Cholangitis (Streetinsider.com) - "It is currently in Phase 2 trials for primary sclerosing cholangitis and liver fibrosis, with a Phase 2 trial in systemic sclerosis expected to begin enrolling patients in early 2023."

New P2 trial • Systemic Sclerosis

CM-101: Top-line data from P2 trial for systemic sclerosis in H2 2024 (Chemomab Therap) - Corporate Overview

P2 data • Systemic Sclerosis

Chemomab Therapeutics Announces Third Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Chemomab has completed the design of its upcoming Phase 2 trial in systemic sclerosis. The company aims to establish biological proof of concept for clinically relevant aspects of this complex disease, focusing on CM-101's potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients....The trial is a randomized, double-blind, placebo-controlled study that will enroll sixty (60) SSc patients....The primary outcome measure for the trial will be demonstration of the safety and tolerability of treatment with CM-101....We intend to conduct this study at multiple sites in the U.S., the E.U. and Israel. We are currently finalizing the required regulatory documents and we intend to file an Investigational New Drug application with the U.S. Food and Drug Administration in the coming weeks."

IND • New P2 trial • Systemic Sclerosis

Chemomab Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter-over-quarter primarily reflects the ramp-up in activities supporting the company's clinical programs for CM-101."

Commercial • Systemic Sclerosis

Chemomab Therapeutics to Present at June Investor and Scientific Conferences (PRNewswire) - "Chemomab Therapeutics Ltd...announced that the company will participate in a number of investor and scientific conferences in June 2022....CCL24 Inhibition by CM-101 Attenuates Extracellular Matrix and Fibrotic Biomarkers in Both Patients and Experimental Murine Models..."

Biomarker • Clinical • Preclinical • Systemic Sclerosis