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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 appointed Jill M. Quigley to its board of directors. Quigley brings over 20 years of experience in biotechnology leadership, including executive roles in management, operations, and legal affairs. Her expertise includes working with companies focused on innovative therapeutics for rare diseases. Chemomab is advancing its antibody CM-101 through clinical trials for serious conditions like primary sclerosing cholangitis and systemic sclerosis. This appointment is expected to enhance Chemomab's strategic direction and operational efficacy.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) announced its participation in various investor and scientific conferences in June 2022, aimed at presenting its groundbreaking work in fibrotic and inflammatory diseases. Notable events include the JMP Securities Life Sciences Conference on June 16 in New York, and the Extracellular Matrix Pharmacology Congress from June 23-25 in Copenhagen. Chemomab's lead asset, CM-101, is in Phase 2 trials for several severe conditions, including primary sclerosing cholangitis, and is expected to advance into systemic sclerosis trials later this year.
Chemomab Therapeutics reported significant findings regarding CCL24 as a therapeutic target for systemic sclerosis at the EULAR European Congress of Rheumatology. Their CCL24-neutralizing antibody, CM-101, is set to enter Phase 2 trials later this year. The study indicated elevated CCL24 levels correlated with disease activity and prognosis in diffuse cutaneous systemic sclerosis patients. These findings strengthen the rationale for CM-101's clinical trials, aimed at addressing a critical unmet need in treating this severe autoimmune disease.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company, will participate in the virtual H.C. Wainwright Global Investment Conference from May 23-26, 2022. Management will deliver a corporate overview webcast available on demand starting at 7:00 am ET on May 24. Additionally, Chemomab will engage in one-on-one meetings with investors. The company focuses on innovative therapeutics for fibrotic and inflammatory diseases, with its CM-101 monoclonal antibody currently in Phase 2 trials for severe conditions like primary sclerosing cholangitis and lung fibrosis.
Chemomab Therapeutics (CMMB) reported its Q1 2022 financial results, revealing a net loss of $5.1 million, or $0.02 per share, compared to a $1.7 million loss in Q1 2021. Cash and equivalents decreased to $57.5 million from $61.2 million at year-end 2021. R&D expenses rose significantly to $2.7 million, while G&A expenses jumped to $2.6 million, influenced by stock-based compensation. The company is progressing in its CM-101 clinical trial for fibrotic diseases, expanding into new regions, with an interim analysis expected later this year.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) will announce its first quarter 2022 financial results and provide a business update on May 12, 2022, during a conference call at 8:00 am ET. The call will review performance, recent events, and feature a live Q&A session. Chemomab focuses on developing therapeutics for fibrotic and inflammatory diseases, with its CM-101 monoclonal antibody currently in two Phase 2 trials for severe conditions affecting the liver and systemic sclerosis. For further details, visit chemomab.com.
Chemomab Therapeutics Ltd (Nasdaq: CMMB), a clinical-stage biotechnology company, will participate in the virtual Cantor Fitzgerald Rare Orphan Disease Summit on March 29, 2022. Co-founder and Chief Scientific Officer Adi Mor will be a panelist. The discussion will focus on 'Platforms and Pipelines in a Product', highlighting potential applications across various rare diseases. Chemomab specializes in innovative therapies for fibrotic and inflammatory diseases, with their lead product, CM-101, in Phase 2 trials for multiple conditions.
Chemomab Therapeutics (Nasdaq: CMMB) presented significant findings regarding its lead candidate, CM-101, at recent conferences in Israel. Data indicated that CCL24 levels were elevated in patients with diffuse cutaneous systemic sclerosis (dcSSc), correlating with disease activity and poor prognosis. The company plans to initiate a Phase 2 trial for CM-101 later this year, aiming to target CCL24 to address unmet needs in systemic sclerosis, a serious autoimmune disease.
Chemomab Therapeutics, Ltd. (CMMB) reported its fourth quarter and full-year 2021 financial results, showcasing a cash position of $61.2 million compared to $11.8 million in 2020. R&D expenses rose to $2.4 million for Q4 and $6.3 million for the year, while G&A expenses increased to $2.6 million for Q4 and $6.0 million for the year. The net loss was $5.0 million for Q4, totaling $12.5 million for 2021. Significant clinical program revisions were announced, aimed at optimizing the development of CM-101, including expanded trials for PSC and SSc, with more data readouts expected over the next 24 months.
Chemomab Therapeutics (CMMB) will announce its fourth quarter and full year 2021 financial results on March 9, 2022. The company focuses on developing therapeutics for fibrotic and inflammatory diseases. A conference call will be held at 8:00 a.m. Eastern Time to discuss performance and upcoming events. Chemomab's key product, CM-101, is currently undergoing two Phase 2 trials with a third set to start in early 2022. This innovative approach targets the CCL24 protein, which is central to fibrosis and inflammation.