Chemomab Therapeutics (NASDAQ:CMMB) highlighted progress for its lead candidate nebokitug during a presentation at Oppenheimer’s 36th Annual Healthcare Conference, outlining Phase 2 data in primary sclerosing cholangitis (PSC), plans for a Phase 3 program, and the company’s broader fibrosis and inflammation strategy.
Company focus and lead program
Chief Executive Officer Adi Mor described Chemomab as a clinical-stage company developing therapies for inflammatory and fibrotic diseases. The company’s lead asset, nebokitug, is a first-in-class monoclonal antibody designed to neutralize CCL24, a soluble cytokine that Mor said can drive fibrosis through two pathways: regulation of type 2 immune responses and direct activation of fibroblasts.
PSC opportunity and Phase 2 design
Mor characterized PSC as a rare fibrotic liver disease affecting the bile ducts that can progress to end-stage liver disease. He said there are no FDA-approved drugs for PSC and that liver transplant is the only treatment with curative potential, though disease recurrence can occur.
He estimated there are approximately 70,000 PSC patients across the seven major markets and said the commercial opportunity “may exceed $1 billion” in revenue. In the question-and-answer session, Mor added that the $1 billion figure was based on “conservative assumptions” focused on the moderate-to-advanced population.
Chemomab’s Phase 2 PSC study randomized 76 patients into three groups: two nebokitug dosing arms (10 mg/kg and 20 mg/kg) and placebo. Patients received 15 weeks of double-blind treatment and then could enter an open-label extension for up to 48 weeks total. Mor said the primary endpoint was safety and tolerability, while secondary endpoints included markers associated with disease progression such as liver stiffness and ELF score, along with additional fibrosis biomarkers and inflammatory cytokines.
The company’s analysis plan included evaluating all completers and separately examining patients with moderate-to-advanced fibrosis, which Mor described as the target population expected to show clearer changes within the study timeframe.
Key Phase 2 readouts and dose selection
Mor said the Phase 2 study met its primary and secondary endpoints, with nebokitug appearing safe and well-tolerated and showing improvement across inflammatory and fibrotic markers. He emphasized two “take-home messages”:
- Dose: 20 mg/kg was selected to advance based on safety and activity.
- Target population: Patients with moderate-to-advanced disease showed more prominent results, and Chemomab plans to focus or enrich this population in Phase 3.
Discussing biomarker data, Mor said liver stiffness improved after 15 weeks in patients treated with nebokitug, with statistically significant and more pronounced effects in those with moderate-to-advanced disease at baseline. For ELF score, he said patients with moderate-to-advanced disease treated with 20 mg/kg showed an absolute improvement of 0.13 after 15 weeks.
Mor also cited reductions across other fibrosis-related markers (including TIMP-1, P-III-NP, PRO-C3, and TGF-beta) and said inflammatory biomarkers such as IL-6, IL-18, and CD14 decreased in a dose-dependent manner following 15 weeks of treatment.
In the open-label extension, Mor said 93% of eligible patients continued treatment through 48 weeks. He reported that nebokitug remained safe and well-tolerated at both doses and that biomarkers tied to disease progression, including ELF-related components and PRO-C3, continued to show absolute reductions over 48 weeks. Mor added that in the moderate-to-advanced subgroup receiving 20 mg/kg, ELF showed an absolute reduction of -0.4 at 48 weeks.
He also said Chemomab evaluated clinical events despite the study not being powered for them. Mor reported that 4.8% of patients treated for 48 weeks experienced a PSC-related clinical event, compared with about 26% in a matched historical study population, which he described as “80% less events” after one year versus historical data.
Phase 3 plans, partnering, and cash runway
Mor said Chemomab has aligned with the FDA on a Phase 3 design intended to support full approval, using a single study. The planned trial would evaluate time to first event on a composite clinical endpoint that includes ascending cholangitis, strictures requiring intervention, portal hypertension, hepatic decompensation, MELD score above 15, liver transplant, and death. Mor said the company plans to incorporate an interim analysis, which could support an earlier BLA filing if results are “very massive.”
He said Chemomab intends to start Phase 3 in PSC with a partner and is advancing partnering discussions. In Q&A, Mor said the company has not disclosed the expected cost of the Phase 3 trial, but described partnering as a way to be more cost-effective and reduce the need for equity financing. He also said the company is considering partner expertise and commercial capabilities, whether through global or regional arrangements.
On patient selection, Mor said roughly 50% of PSC patients may have moderate-to-advanced disease (F2, F3, and possibly F4A), and that a similar proportion represented the Phase 2 population. He stated that Chemomab expects to enrich Phase 3 enrollment using inclusion thresholds such as ELF and/or liver stiffness, while noting he did not expect the eventual label to necessarily be restricted only to moderate-to-advanced patients.
Mor also provided an update on liquidity, stating that Chemomab reported approximately $20.8 million in cash at its last earnings update, which he said should fund the company through the end of 2026. He said the cash runway is expected to support Phase 3 preparations primarily related to CMC and manufacturing clinical materials, as well as additional interactions with regulators including the FDA and EMA.
Systemic sclerosis rationale
Beyond PSC, Mor pointed to systemic sclerosis as another target indication, describing it as a rare inflammatory rheumatic disease that primarily affects women and involves inflammation and fibrosis in skin, vasculature, and internal organs. He said lung involvement is the leading cause of death, and while there are two approved drugs for lung disease associated with SSc, there are no disease-modifying therapies currently available.
Mor estimated there are about 180,000 SSc patients across the seven major markets and described a commercial opportunity exceeding $1.5 billion. He said Chemomab research has shown CCL24 is elevated in SSc patient skin compared with healthy skin and that CCL24 predicts mortality. He also said CCL24 is elevated in patients with interstitial lung disease (ILD) and is predictive of ILD deterioration, including declines in forced vital capacity. In discussing possible Phase 2 design for SSc, Mor said it was “too soon” to define the exact approach, but he suggested evaluating the drug’s effects beyond only ILD given the mechanism’s relevance across skin, lung, and vasculature.
During Q&A, Mor said partner interest has been strongest in PSC because it represents what he called the quickest path to market based on Phase 2 proof of concept and the potential for a single Phase 3 registration study, while noting there is also interest in systemic sclerosis and other CCL24-relevant indications. He added that some partners had previously wanted to see clinical proof of concept given CCL24’s novelty as a target.
About Chemomab Therapeutics (NASDAQ:CMMB)
Chemomab Therapeutics (NASDAQ:CMMB) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of next-generation antibody therapies. The company leverages a proprietary antibody engineering platform to generate novel bi- and multi-specific antibodies with applications in oncology, infectious diseases and inflammatory disorders. By combining cutting-edge discovery tools with translational research, Chemomab aims to advance promising candidates from early proof-of-concept through clinical development.
Among its pipeline programs, Chemomab is advancing antibody candidates designed to target key tumor antigens and pathogen-specific epitopes.
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