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Chemomab Therapeutics Ltd. reports developments for its clinical-stage biotechnology program in fibro-inflammatory diseases. Recurring updates center on nebokitug, an antibody targeting CCL24, and its clinical evaluation in primary sclerosing cholangitis through the SPRING trial, related open-label extension data, biomarker findings, macrophage-mediated mechanism research, and peer-reviewed or medical-meeting presentations.
Company news also covers financial results, corporate updates, regulatory interactions with agencies, preparations for later-stage development, strategic partnering discussions, capital-raising activity involving American Depositary Shares, and participation in healthcare and rare-disease investor conferences.
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.