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 Ltd. (Nasdaq: CMMB) has appointed Dale R. Pfost, PhD, as its new Chief Executive Officer. He will replace co-founder Adi Mor, who will continue as Chief Scientific Officer. Dr. Pfost brings over 30 years of experience in the biotech industry, having successfully led six companies and overseen several public offerings. His appointment reflects a strategic expansion of the senior management team as Chemomab progresses with two ongoing Phase 2 studies and prepares for a third trial. Shareholder approval for his role is expected in Q4 2021.
Chemomab Therapeutics, Ltd (Nasdaq: CMMB), a clinical-stage biotech firm, will attend several investor conferences in September 2021. Key events include the Citi 16th Annual BioPharma Virtual Conference from September 8-10, the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, and the Oppenheimer Fall Healthcare Summit on September 22. The company's lead product, CM-101, a monoclonal antibody targeting fibrosis, is currently in Phase 2 trials for primary sclerosing cholangitis and systemic sclerosis. Further information can be found on their website.
Chemomab Therapeutics Ltd (Nasdaq: CMMB), a clinical-stage biotech firm, reported its financial and operational results for Q2 2021. As of June 30, 2021, the company had $67 million in cash, sufficient to fund operations into mid-2023. The company is advancing three Phase 2 trials for its lead product, CM-101, targeting fibrosis-related diseases. The ongoing SPRING and SPLASH trials are set to yield data in 2022. Despite rising R&D and administrative expenses totaling $2.8 million, Chemomab remains optimistic about its pipeline and collaborations, particularly with AGC Biologics.
Chemomab Therapeutics, Ltd. (NASDAQ: CMMB) has expanded its partnership with AGC Biologics for the manufacturing of CM-101, a Phase II investigational drug targeting fibrosis-related diseases like Primary Sclerosing Cholangitis and Systemic Sclerosis. The agreement aims to optimize and upscale the manufacturing process for upcoming pivotal studies, with clinical trial materials produced in Copenhagen. CM-101 has shown promise in clinical trials, and the collaboration is expected to enhance manufacturing capabilities ahead of Phase 3 trials.
Chemomab Therapeutics (Nasdaq: CMMB) has announced a poster presentation at the International Liver Congress 2021 from June 23-26, 2021. Dr. Arnon Aharon will present findings related to the role of CCL24 in bile duct fibrosis in primary sclerosing cholangitis (PSC). This presentation, titled The peri-ductular CCL24 rich niche promotes bile duct fibrosis related liver damage in primary sclerosing cholangitis, highlights CCL24's significance in fibrosis-related diseases. Full poster access will be available on Chemomab's website post-event.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) reported positive financial and operational results for Q1 2021, with a cash position of $58.2 million following a $45 million private placement. Key highlights include positive Phase Ib data for CM-101 in nonalcoholic fatty liver disease (NAFLD) and the initiation of Phase IIa trials for both primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH). The company plans to start an additional Phase II trial for Systemic Sclerosis (SSc) by year-end 2021. Net loss remained stable at $1.7 million for the quarter.
Chemomab Therapeutics Ltd (Nasdaq: CMMB) announced its CEO, Dr. Adi Mor, will present a corporate update at the Oppenheimer Virtual Rare and Orphan Disease Summit on May 21, 2021.
The event aims to share insights on Chemomab's innovative therapeutics targeting fibrosis-related diseases, particularly its monoclonal antibody CM-101, which is in clinical development for orphan diseases like Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc).
The presentation will be available online for 30 days following the event.
Chemomab Therapeutics (Nasdaq: CMMB) has started enrollment for its Phase 2a study of CM-101 aimed at treating Non-Alcoholic Steatohepatitis (NASH). CM-101, a humanized monoclonal antibody, targets CCL24 to mitigate inflammation and fibrosis. The randomized, double-blind trial will involve 40 patients and aims to evaluate CM-101's safety and anti-fibrotic effects, with results expected in the first half of 2022. This study is part of Chemomab’s broader clinical strategy, which includes ongoing trials for other fibrosis-related conditions.
Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) has appointed four new members to its Board of Directors, including Dr. Alan Moses, Dr. Claude Nicaise, Mr. Joel Maryles, and Mr. Neil Cohen. This strategic move aims to enhance clinical and regulatory expertise as the company progresses its proof-of-concept trials for CM-101, a therapeutic targeting fibrosis-related diseases. Additionally, Chemomab successfully completed a PIPE financing round, raising $45.5 million, with approximately 11.9 million ADSs outstanding on a fully diluted basis.
The Genesis Prize Foundation announced that Stan Polovets has stepped down as chairman of Anchiano Therapeutics following its merger with Chemomab Therapeutics on March 16, now trading as CMMB. During Polovets' tenure, Anchiano's stock surged 630%, outperforming many peers. The merger aims to focus on innovative therapies for inflammation and fibrosis, backed by significant investor financing. Polovets expressed gratitude for the management team's efforts, highlighting the company’s potential for further success in the biotech space.
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