Welcome to our dedicated page for Chemomab Therapeutics news (Ticker: CMMB), a resource for investors and traders seeking the latest updates and insights on Chemomab Therapeutics stock.
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) announced a positive safety review from an independent Data Monitoring Committee for its ongoing Phase 2 trial of CM-101 in patients with primary sclerosing cholangitis (PSC). The DMC found no safety concerns in advancing to a higher dose cohort of 20 mg/kg, alongside the current 10 mg/kg dosing. CM-101, a monoclonal antibody targeting CCL24, aims to treat fibrotic and inflammatory diseases. Top-line results from this PSC trial are expected in H2 2024, with additional insights from a separate liver fibrosis biomarker trial anticipated soon.
Chemomab Therapeutics (Nasdaq: CMMB) has appointed Mitchell L. Jones, MD, PhD, as Vice President of Corporate Development & Strategy. Dr. Jones's expertise spans over 15 years in biopharmaceuticals, focusing on clinical development and corporate strategy. He previously held key roles at Nasdaq-listed companies Finch Therapeutics and Biora Therapeutics. Dr. Jones aims to advance Chemomab's CM-101 product, targeting fibrotic and inflammatory diseases. This move is seen as a strategic enhancement for Chemomab's leadership as it progresses through clinical trials.
Chemomab Therapeutics (Nasdaq: CMMB) reported its Q3 2022 financial and operational results, revealing a net loss of $8.1 million, up from $3.0 million in Q3 2021. Cash reserves stood at $46.5 million, expected to sustain operations through year-end 2023. Key developments include progression in clinical trials for CM-101, with imminent results from the liver fibrosis trial in NASH patients. The company is also advancing a Phase 2 trial in systemic sclerosis, targeting 60 patients, and has opened additional sites in Europe and the U.S. for ongoing studies.
Chemomab Therapeutics (Nasdaq: CMMB) has presented new clinical data indicating that CM-101, a monoclonal antibody, is safe and well-tolerated in patients with COVID-19-derived lung injury. The study, conducted on 16 hospitalized patients, showed significant reductions in lung inflammation and fibrogenesis biomarkers. Key findings included a 65% reduction in CXCL10 levels within 24 hours and a 50% decrease in C-reactive protein (CRP) after 48 hours. CM-101 aims to treat inflammatory and fibrotic diseases, with ongoing Phase 2 trials for primary sclerosing cholangitis and systemic sclerosis.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) will announce its third quarter 2022 financial results on November 11, 2022, at 8:00 am Eastern Time. The event will include a review of performance, recent developments, and a live Q&A session. The company is focused on developing therapeutics for fibrotic and inflammatory diseases, with its lead product, CM-101, in Phase 2 trials for conditions including liver fibrosis. A replay of the call will be available on the company’s website for 90 days following the event.
Chemomab Therapeutics Ltd (Nasdaq: CMMB), a clinical-stage biotechnology company, announced its participation in key scientific conferences in November 2022. Notably, it will present a poster on CCL24 Blockade at the AASLD - The Liver Meeting from November 4-8, and an oral presentation on CM-101 at the Union World Conference on Lung Health from November 8-11. These presentations aim to showcase advancements in therapeutics for fibrotic and inflammatory diseases.
Chemomab Therapeutics (CMMB) reported its Q2 2022 financial results, highlighting significant progress in its clinical programs, particularly CM-101, a monoclonal antibody targeting fibrosis and inflammation. The company concluded the treatment phase of a Phase 2 trial for liver fibrosis in NASH patients, with topline results expected by year-end. Chemomab also received a U.S. patent for CM-101 in liver diseases, extending its protection until at least 2038. Financially, the company had $51.8 million in cash, with a net loss of $6.2 million for the quarter.
Chemomab Therapeutics (Nasdaq: CMMB) announced the appointment of Ilan Vaknin, PhD, as Vice President of Research & Development and Christina Crater, MD, as Vice President of Clinical Development. These appointments aim to strengthen the development of CM-101, a monoclonal antibody targeting fibrotic and inflammatory diseases. Key upcoming events include reporting topline results from a Phase 2 trial in liver fibrosis and launching a Phase 2 trial for systemic sclerosis. Both executives bring significant expertise that is expected to accelerate Chemomab's clinical activities and pipeline programs.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) announced it will release its second quarter 2022 financial results and provide a business update on August 12, 2022, at 8:00 am Eastern Time. During this event, the management team will review Q2 performance, discuss recent developments, and host a live Q&A session. The company specializes in developing therapeutics for fibrotic and inflammatory diseases, focusing on its monoclonal antibody CM-101, which is currently in Phase 2 trials for primary sclerosing cholangitis and liver fibrosis.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) reported significant findings from presentations at the 2022 EASL International Liver Congress and the First International Extracellular Matrix Pharmacology Congress. The data highlights the role of the soluble protein CCL24 in liver diseases, specifically primary sclerosing cholangitis (PSC). Findings suggest that Chemomab's CCL24 neutralizing antibody CM-101 can effectively influence extracellular matrix remodeling, showing promise in clinical applications for PSC. The studies support the ongoing development of CM-101 in Phase 2 trials.
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