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 announced key leadership changes in its medical and clinical teams. David M. Weiner, MD, has been appointed as Interim Chief Medical Officer, returning to a role he previously held in 2021-2022. Additionally, Jack Lawler has been promoted to Chief Development Officer.
Dr. Weiner brings over 25 years of experience in therapeutic discovery and clinical development, replacing Matt Frankel, MD. Lawler, who joined Chemomab in 2022, has been credited with leading the successful Phase 2 SPRING trial for nebokitug in primary sclerosing cholangitis (PSC).
The appointments come at a important time following the company's successful completion of the Phase 2 PSC program. Nebokitug has shown potential to become the first FDA-approved drug for PSC with disease-modifying activity. The company is currently planning its next steps following these positive clinical results.
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.