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About Chemomab Therapeutics Ltd.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) is a clinical-stage biotechnology company pioneering the development of innovative therapies for fibro-inflammatory diseases with significant unmet medical needs. Based in Tel Aviv, Israel, Chemomab's research focuses on addressing the underlying mechanisms of fibrosis and inflammation, conditions that contribute to a range of severe and life-threatening diseases. The company's lead therapeutic candidate, nebokitug (CM-101), is a first-in-class monoclonal antibody designed to neutralize the soluble protein CCL24, a key regulator of inflammatory and fibrotic pathways.
Core Therapeutic Focus and Mechanism of Action
Nebokitug (CM-101) operates through a unique dual mechanism of action, targeting both immune cell recruitment and fibroblast activation. By inhibiting CCL24, nebokitug disrupts the self-perpetuating fibro-inflammatory cycle that drives fibrosis. This approach has shown promise in addressing a variety of fibro-inflammatory diseases, including primary sclerosing cholangitis (PSC), a rare and progressive liver disease, and systemic sclerosis (SSc), a debilitating autoimmune condition affecting the skin, lungs, and other organs.
Clinical Development and Regulatory Milestones
Chemomab has advanced nebokitug through multiple clinical trials, demonstrating its safety, tolerability, and efficacy. The company's Phase 2 SPRING trial in PSC established clinical proof-of-concept, showing improvements across a range of disease biomarkers, including liver stiffness, Enhanced Liver Fibrosis (ELF) scores, and pruritus severity. These results have positioned nebokitug as the first investigative therapy for PSC with broad activity across all major disease components.
In collaboration with the U.S. Food and Drug Administration (FDA), Chemomab recently secured alignment on the design of a single Phase 3 registration trial for nebokitug in PSC. This pivotal trial will evaluate clinically meaningful endpoints, such as time-to-first-event of disease progression, without requiring invasive liver biopsies. This streamlined pathway offers a significant acceleration toward potential full regulatory approval.
Market Position and Competitive Advantages
Chemomab's focus on fibro-inflammatory diseases with high unmet needs provides a strategic advantage in the biotechnology sector. Nebokitug has received Orphan Drug and Fast Track designations from both the FDA and the European Medicines Agency (EMA), underscoring its potential to address critical gaps in treatment. The company's robust intellectual property portfolio, including patents extending to 2038, further strengthens its market position.
With an estimated 30,000 PSC patients in the U.S. and 80,000 worldwide, as well as significant unmet needs in related conditions like systemic sclerosis, Chemomab is well-positioned to capture a substantial share of these markets. Additionally, the company's ongoing discussions with strategic partners could accelerate the development and commercialization of nebokitug across multiple indications.
Future Outlook
Chemomab is preparing to launch its Phase 3 PSC trial in late 2025, with results from the open-label extension of the Phase 2 SPRING trial expected in early 2025. These milestones, coupled with the company's proactive engagement with regulatory authorities and potential biopharma partners, highlight its commitment to delivering transformative therapies. By addressing the root causes of fibro-inflammatory diseases, Chemomab aims to improve patient outcomes and establish itself as a leader in this specialized therapeutic domain.
Key Takeaways
- Innovative Science: First-in-class monoclonal antibody targeting CCL24, a novel driver of fibrosis and inflammation.
- Clinical Progress: Positive Phase 2 data in PSC, with Phase 3 trial design aligned with FDA guidance.
- Regulatory Advantages: Orphan Drug and Fast Track designations for nebokitug in PSC.
- Market Potential: Addressing high unmet needs in rare fibro-inflammatory diseases.
- Strategic Partnerships: Active discussions with biopharma companies to accelerate development timelines.
Chemomab Therapeutics (Nasdaq: CMMB) has reported positive results from the Open Label Extension (OLE) portion of its Phase 2 SPRING trial for nebokitug in primary sclerosing cholangitis (PSC) patients. The trial showed continued improvements across key liver biomarkers after 48 weeks of treatment.
Key findings include:
- Over 90% of eligible SPRING trial patients participated in the OLE
- Patients with moderate/advanced disease showed significantly lower clinical events (4.8%) compared to historical controls (25.8%)
- Treatment demonstrated improvements in liver injury, inflammation, and fibrosis markers
- The drug was well-tolerated at both 10 mg/kg and 20 mg/kg doses administered every three weeks
The results support nebokitug's potential to become the first approved drug with disease-modifying activity for PSC, a deadly disorder currently lacking effective treatments. The 20 mg/kg dose showed particularly strong results and will be used in the upcoming Phase 3 trial.
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 reported successful completion of FDA End-of-Phase 2 Meeting for nebokitug (CM-101) in Primary Sclerosing Cholangitis (PSC). The company achieved alignment with FDA on a streamlined pathway to potential regulatory approval through a single pivotal Phase 3 trial, without requiring liver biopsies or confirmatory studies.
The Phase 2 SPRING trial met its primary endpoint, demonstrating favorable safety profile. Patients with moderate/advanced disease showed improvements across multiple secondary efficacy endpoints. The company selected the 20mg/kg dose for the Phase 3 trial based on observed dose-dependent responses.
Financial highlights for 2024:
- Cash position: $14.3 million as of December 31, 2024
- R&D expenses: $11.3 million for full year (down from $18.4 million in 2023)
- G&A expenses: $3.4 million (decreased from $7.1 million in 2023)
- Net loss: $13.9 million ($0.04 per share)
The company completed a $10 million private placement in July 2024 with participation from OrbiMed, HBM Partners, and Sphera Biotech Master Fund. Current cash runway extends through Q1 2026.
Chemomab Therapeutics (Nasdaq: CMMB) has successfully completed its End-of-Phase 2 Meeting with the FDA, securing alignment on a single Phase 3 registration study design for nebokitug in Primary Sclerosing Cholangitis (PSC). The Phase 3 trial will require approximately 350 PSC patients and focus on time-to-first-event of well-characterized PSC clinical events, without requiring liver biopsies or additional confirmatory studies.
The streamlined approval pathway could potentially make nebokitug the first FDA-approved treatment for PSC. The trial design is supported by published PSC data linking biomarker improvements seen in the Phase 2 SPRING trial with reduced clinical events. The company expects to report topline data from the SPRING trial's open label extension by the end of Q1 and potentially launch the Phase 3 program before year-end.
The company is currently in discussions with potential strategic partners while preparing for the Phase 3 trial, which is estimated to require about two years for participants to experience clinically-meaningful events.
Chemomab Therapeutics (Nasdaq: CMMB) has announced its participation in the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025. CEO Dr. Adi Mor and senior management will deliver a corporate presentation at 8:00 am ET, which will be webcast live and available on the company's website for 90 days.
Chemomab is advancing CM-101, a first-in-class monoclonal antibody targeting CCL24, for fibro-inflammatory diseases. The company recently reported positive results from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC). Two key milestones are expected in early 2025: establishing an FDA registrational pathway for CM-101's Phase 3 pivotal trial and reporting data from the SPRING trial open label extension.
The company plans to initiate the PSC Phase 3 trial by year-end. CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC treatment. Additionally, their CM-101 program for systemic sclerosis is Phase 2-ready with an open U.S. IND.
Chemomab Therapeutics (Nasdaq: CMMB), a clinical stage biotech company focused on fibro-inflammatory diseases, announces its participation in Oppenheimer's Movers in Rare Disease Summit on December 12, 2024, at the Westin Grand Central in New York City. The invitation-only event will showcase companies with potential near-term stock-moving catalysts through panels, presentations, and one-on-one investor meetings. Chemomab's management will deliver an Elevator Pitch at 2:45-3:30 pm EST and will be available for individual meetings with registered attendees.
Chemomab Therapeutics presented Phase 2 SPRING trial data for CM-101 in primary sclerosing cholangitis (PSC) at AASLD The Liver Meeting® 2024. The trial, involving 76 patients, tested two doses (10 mg/kg and 20 mg/kg) administered every three weeks over 15 weeks. CM-101 met its primary safety endpoint and showed dose-dependent improvements across multiple biomarkers. The higher 20 mg/kg dose demonstrated greater improvements, particularly in patients with moderate/advanced disease, showing anti-fibrotic, anti-inflammatory, and anti-cholestatic effects. Key improvements were observed in liver stiffness, ELF scores, PRO-C3 levels, liver biochemistries, bilirubin levels, and pruritus scores.
Chemomab Therapeutics (Nasdaq: CMMB) reported Q3 2024 financial results and announced key developments. The company has scheduled an FDA End-of-Phase 2 Meeting in Q4 2024 to discuss CM-101's Phase 3 trial design for Primary Sclerosing Cholangitis (PSC). Their cash position stands at $19.5 million as of September 30, 2024, with runway extended to early 2026 following a $10 million private placement. Q3 net loss was $3.5 million, with R&D expenses at $2.8 million and G&A expenses at $0.9 million. The company reported positive Phase 2 SPRING trial results for CM-101 in PSC patients, with plans to advance to Phase 3 in late 2025.
Chemomab Therapeutics (Nasdaq: CMMB), a clinical stage biotech company focused on fibro-inflammatory disease treatments, announced it will release its Q3 2024 financial results and business update on November 14, 2024, at 7:00 am ET. Investors interested in discussing the results after the release can contact the company via IR@chemomab.com.
Chemomab Therapeutics (Nasdaq: CMMB) announced that its late-breaking abstract on the Phase 2 SPRING trial results for CM-101 in primary sclerosing cholangitis (PSC) has been selected for an oral presentation at the AASLD The Liver Meeting® 2024. The conference will be held in San Diego from November 15-19, 2024.
Professor Christopher Bowlus, MD, FAASLD, from the University of California Davis School of Medicine, will present the data from the double-blinded portion of the trial. The presentation, titled 'CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING Study', is scheduled for November 18, 2024, from 2:45-3:00pm PT during the Late Breaking Abstract Parallel Session 1.
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