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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 Ltd. (Nasdaq: CMMB), a biotechnology firm specializing in innovative therapeutics for fibro-inflammatory diseases, announced its participation in the Aegis 2023 Virtual Investor Conference from May 2 to May 4, 2023. Chemomab's management will present a corporate overview on May 3, 2023, at 9:00 AM EDT. The event will be held virtually, and investors can access the webcast through a provided link.
Additionally, Chemomab's corporate development team will attend the BIO International Convention's One-on-One Partnering™ event in Boston from June 5 to June 8, 2023. They encourage registered attendees to schedule meetings via an online portal.
The company focuses on creating therapies like CM-101, a monoclonal antibody aimed at treating severe fibro-inflammatory diseases, backed by ongoing Phase 2 trials.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) announced its participation in several scientific conferences during April and May 2023. Key events include the British Society for Rheumatology Annual Conference from April 24-26, where Chemomab will present an oral presentation on CCL24 serum concentration and its relevance in systemic sclerosis. The second event is the EASL Monothematic Conference on Biliary Fibrosis from May 12-13, highlighting a poster presentation on the role of CCL24 in cholestatic disease. Additionally, Chemomab's corporate development team will attend the BIO International Convention in Boston from June 5-8, focusing on partnership opportunities. Chemomab aims to advance innovative therapeutics for fibro-inflammatory diseases, particularly through its monoclonal antibody CM-101, which targets CCL24.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company, will hold a webcast and conference call on May 11, 2023, at 8:00 am ET to discuss its first quarter 2023 financial results and provide a corporate update. This event replaces a previous update originally set for April 17, 2023. During the call, the management team will review the company's performance, recent developments, and host a Q&A session. A replay will be available on their website for 90 days. Chemomab focuses on developing therapeutics for fibro-inflammatory diseases and has seen promising results from its lead product, CM-101, in various ongoing studies.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) will hold a Corporate Update on April 17, 2023, at 8:00 am Eastern Time. This replaces a previously scheduled webcast on March 31, 2023. The management team will review recent developments and answer questions from investors. Chemomab focuses on innovative therapies for fibro-inflammatory diseases, with CM-101 showing promise in trials for liver fibrosis and severe lung injury in COVID-19 patients. A Phase 2 trial for primary sclerosing cholangitis is ongoing, and a similar trial for systemic sclerosis is expected to open mid-2023.
Chemomab Therapeutics (Nasdaq: CMMB) will present its Q4 and full-year 2022 financial results on March 31, 2023, at 8:00 am Eastern Time. The management team will review the company’s performance and discuss future developments during the call, which includes a live question-and-answer session. Notably, the company focuses on developing therapeutics to address fibro-inflammatory diseases. Their key product, CM-101, aims to treat severe diseases related to fibrosis and inflammation, with recent positive results from clinical studies. A replay of the event will be available for 90 days on their website.
Chemomab Therapeutics, a clinical-stage biotech company focused on fibro-inflammatory diseases, will present a corporate overview at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023. The conference will be held virtually, with the presentation scheduled for 9:20 am ET. Investors can also request 1-on-1 meetings with management through Oppenheimer representatives. Chemomab is advancing its lead product, CM-101, targeting fibrosis and inflammation. Recent developments include completing a Phase 2 liver fibrosis biomarker study and preparing for a Phase 2 trial in systemic sclerosis in the first half of 2023. More details are available at investors.chemomab.com/events.
Chemomab Therapeutics (CMMB) received FDA clearance for the Phase 2 ABATE trial to evaluate CM-101 in patients with systemic sclerosis (SSc). The trial aims to assess safety and establish proof-of-concept for CM-101, a monoclonal antibody targeting fibrosis in SSc. CM-101 has shown promise in preclinical studies, reducing fibrotic injury in affected organ systems. The ABATE trial targets 45 patients and emphasizes safety as its primary endpoint, with results anticipated in the second half of 2024. CM-101 is positioned to potentially become the first disease-modifying treatment for SSc, a condition affecting approximately 100,000 patients in the U.S.
Chemomab Therapeutics (CMMB) announced positive results from its Phase 2a trial of CM-101 in NASH patients. The trial met its primary endpoint of safety and tolerability, with most adverse events being mild. CM-101 demonstrated significant reductions in liver fibrosis biomarkers, with nearly 60% of treated patients improving in three or more biomarkers. The trial included 23 patients receiving either CM-101 or placebo over 16 weeks. These findings reinforce Chemomab's ongoing optimism for CM-101's potential in treating fibrotic diseases.
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.
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