A Phase 2, Multicenter, Randomized, Double-Blind, Proof of Biology Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.

Start Date01 Sep 2024

Sponsor / Collaborator

Chemomab Ltd.

NCT05824156 / CompletedPhase 2

Phase 2A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of CM-101 in Patients With Non-Alcoholic Steatohepatitis (NASH)

This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment groups: 5 mg/kg CM-101 or placebo.

Start Date24 Feb 2021

Sponsor / Collaborator

Chemomab Ltd.

NCT04595825 / Active, not recruitingPhase 2

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects With Primary Sclerosing Cholangitis (The SPRING Study)

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

Start Date01 Oct 2020

Sponsor / Collaborator

Chemomab Ltd.

100 Clinical Results associated with Nebokitug

100 Translational Medicine associated with Nebokitug

100 Patents (Medical) associated with Nebokitug

Literatures (Medical) associated with Nebokitug

01 Sep 2024·DRUG SAFETY

Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies

Article

Author: Friedman, Scott ; Safadi, Rifaat ; Mor, Adi ; Pinzani, Massimo ; Frankel, Matthew ; Hashmueli, Sharon ; Peled, Amnon

BACKGROUND:

Overexpression of C-C motif chemokine ligand 24 (CCL24) is associated with inflammatory and fibrotic diseases, including primary sclerosing cholangitis (PSC), systemic sclerosis, metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). CM-101 is a humanized monoclonal antibody that neutralizes CCL24 to attenuate inflammation and fibrosis in preclinical models. Here we report the results from two Phase 1a studies investigating the safety and tolerability of intravenous (IV) and subcutaneous (SC) CM-101 in healthy participants, and in one Phase 1b study of IV and SC CM-101 in patients with MASLD without evidence of MASH.

METHODS:

In each dose group (0.75 mg/kg, 2.5 mg/kg, 5.0 mg/kg, and 10.0 mg/kg) of the single-center, double-blind, placebo-controlled Phase 1a IV study, healthy volunteers were randomized 3:1 to receive a single IV infusion of CM-101 or placebo. In another Phase 1a, single-center, double-blind placebo-controlled study, healthy volunteers were randomized 3:1 to receive a single SC injection of CM-101 5.0 mg/kg or placebo. In the multicenter, double-blind, placebo-controlled Phase 1b MASLD study, patients with MASLD without evidence of MASH were randomized 3:1 to receive the following: cohort 1, IV CM-101 2.5 mg/kg or placebo, and cohort 2, SC CM-101 5.0 mg/kg or placebo every three weeks for 12 weeks. The primary endpoints (for all these studies) were safety, tolerability, and serum pharmacokinetic parameters of CM-101.

RESULTS:

In each study, adverse events were rare and mild to moderate. The CM-101 pharmacokinetics profile was typical of a monoclonal antibody, with a terminal half-life of approximately 19 days when given IV and approximately 17 days when given as SC injection. In patients with MASLD without evidence of MASH, CM-101 was associated with decreased serum levels of inflammatory, fibrotic, and collagen turnover biomarkers.

CONCLUSIONS:

In healthy volunteers and patients with MASLD without evidence of MASH, IV and SC CM-101 was well tolerated at doses ranging from 0.75 mg/kg to10.0 mg/kg and engaged its target (i.e., CCL24), indicating therapeutic potential in treating inflammatory and fibrotic diseases.

CLINICAL TRIAL RETROSPECTIVELY REGISTRATION:

NCT06025851, NCT06037577, and NCT06044467. Date of registration: September 2023.

01 Feb 2020·JHEP reports : innovation in hepatology

A blocking monoclonal antibody to CCL24 alleviates liver fibrosis and inflammation in experimental models of liver damage

Article

Author: Segal-Salto, Michal ; Edelshtein, Vicktoria ; Maor, Yaakov ; George, Jacob ; Hall, Andrew ; Friedman, Scott ; Barashi, Neta ; Hashmueli, Sharon ; Aharon, Arnon ; Katav, Avi ; Haberman, Dan ; Mor, Adi ; Pinzani, Massimo

BACKGROUND & AIMS:

C-C motif chemokine ligand 24 (CCL24) is a chemokine that regulates inflammatory and fibrotic activities through its receptor, C-C motif chemokine receptor (CCR3). The aim of the study was to evaluate the involvement of the CCL24-CCR3 axis in liver fibrosis and inflammation and to assess the potential of its blockade, by a monoclonal anti-CCL24 antibody, as a therapeutic strategy for non-alcoholic steatohepatitis (NASH) and liver fibrosis.

METHODS:

Expression of CCL24 and CCR3 was evaluated in liver biopsies and blood samples. CCL24 involvement in NAFLD/NASH pathogenesis was assessed in Ccl24 knockout mouse using the methionine-choline deficient (MCD) diet experimental model. Antifibrotic and anti-inflammatory effects of CM-101 were tested in the MCD and STAM mouse models and in the thioacetamide (TAA) model in rats. Liver enzymes, liver morphology, histology and collagen deposition, as well as fibrosis- and inflammation-related protein expression were assessed. Activation of hepatic stellate cells (HSCs) was evaluated in the human LX2 cell line.

RESULTS:

Patients with NASH and advanced NAFLD exhibited significant expression of both CCL24 and CCR3 in liver and blood samples. In the experimental MCD-diet model, Ccl24 knockout mice showed an attenuated liver damage response compared to wild-type mice, exhibiting reduced histological NAFLD activity scores and fibrosis, as well as lower levels of liver enzymes. Blocking CCL24 using CM-101 robustly reduced liver damage in 3 experimental animal models (MCD, STAM and TAA), as demonstrated by attenuation of liver fibrosis and NAFLD activity score. Furthermore, blocking CCL24 by CM-101 significantly inhibited CCL24-induced HSC motility, α-SMA expression and pro-collagen I secretion.

CONCLUSION:

Our results reveal that blocking CCL24 significantly attenuates liver fibrosis and inflammation and may have a potential therapeutic effect in patients with NASH and/or liver fibrosis.

LAY SUMMARY:

CCL24 is a chemokine that regulates inflammation and fibrosis. It was found to be significantly expressed in patients with non-alcoholic steatohepatitis, in whom it regulates profibrotic processes in the liver. Herein, we show that blockade of CCL24 using a monoclonal antibody robustly attenuated liver fibrosis and inflammation in animal models, thus suggesting a potential therapeutic role for an anti-CCL24 agent.

01 Jan 2004·Restorative neurology and neuroscience

Macrophage stimulation using a group B-streptococcus exotoxin (CM101) leads to axonal regrowth in the injured optic nerve.

Article

Author: Hellerqvist, Carl G ; Ohlsson, Marcus ; Mattsson, Per ; Svensson, Mikael ; Wamil, Barbara D

PURPOSE:

A group B-streptococcus exotoxin (CM101) was administered following optic nerve injury in adult rats in order to analyze putative effects on macrophages, glial scar formation and regrowth of axons in the lesioned optic nerve.

METHODS:

After a standardized intraorbital optic nerve crush, animals were randomized to treatment with CM101 (30 microm/kg body weight, iv, repeated every other day) or vehicle alone. Morphology (semithin sections) and immunohistochemistry directed towards macrophages (ED1), neurofilament (NF), astrocytes (GFAP) and regenerative sprouts (GAP43) were employed at different time-points up to 28 dpi.

RESULTS:

A significant increase of ED1-positive macrophages (p < 0.05) was observed at 7, 14 and 28 dpi in treated animals compared to untreated, indicative of macrophage stimulation. Less degenerative structures were found in sections distal to the injury in treated animals, seemingly due to a pro-phagocytic effect. Reactive gliosis was significantly (p < 0.05) less pronounced in CM101-treated animals. The presence of GAP43-positive sprouts and neurofilament-positive neurites distal to the lesion in treated animals indicate regrowth of axons crossing the glial scar.

CONCLUSION:

Treatment with group B-streptococcus exotoxin leads to macrophage stimulation, increased phagocytosis of inhibitory debris, and a less dense reactive gliosis, which in turn allows for regrowth of axons through the glial scar.

News (Medical) associated with Nebokitug

30 Oct 2024

·www.globenewswire.com

Chemomab Therapeutics to Report Third Quarter 2024 Financial Results and Provide a Business Update

TEL AVIV, Israel, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (“Chemomab” or the “Company”), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced the company will issue a press release reporting its third quarter 2024 financial results and providing a business update on November 14, 2024, at 7:00 am Eastern Time. Investors who would like to discuss the financial results or business update after the press release has been issued are invited to contact the company at IR@chemomab.com. About Chemomab Therapeutics Ltd. Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a first-in-class dual activity monoclonal antibody that neutralizes CCL24 activity and has demonstrated disease-modifying potential. In clinical and preclinical studies, CM-101 has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of CM-101 in patients. Based on recent promising data from its Phase 2 SPRING trial in the rare liver disease primary sclerosing cholangitis (PSC), the company expects two milestones in early 2025, including FDA feedback on the design of its planned PSC Phase 3 registrational trial and data from the SPRING trial open label extension. CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC. Chemomab’s CM-101 program for the treatment of systemic sclerosis is Phase 2-ready with an open U.S. IND. For more information, visit: chemomab.com. Contact: Media & Investors: Chemomab TherapeuticsBarbara LindheimConsulting Vice PresidentInvestor & Public Relations, Strategic CommunicationsPhone: +1 917-355-9234barbara.lindheim@chemomab.com IR@chemomab.com

Phase 2Clinical ResultFinancial StatementFast TrackOrphan Drug

15 Oct 2024

·www.globenewswire.com

Chemomab Therapeutics Announces Late-Breaking Oral Presentation of CM-101 Phase 2 Results in Primary Sclerosing Cholangitis at AASLD The Liver Meeting® 2024

TEL AVIV, Israel, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that its late breaking abstract discussing the results of the Phase 2 SPRING trial in primary sclerosing cholangitis (PSC) has been selected for an oral presentation at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024. The conference will take place in San Diego, California, November 15 – 19, 2024. Professor Christopher Bowlus, MD, FAASLD, the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine will give an oral presentation describing data from the double-blinded portion of the Phase 2 SPRING trial assessing CM-101 in individuals with PSC.Title: CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING StudyAuthor: Christopher Bowlus, MDSession: Late Breaking Abstract Parallel Session 1Session Time: November 18, 2024, 2:00pm – 3:30pm PDTPresentation Time: November 18, 2024, 2:45 - 3:00pm PTPublication Number: 5005 Members of the Chemomab senior leadership team will be attending the 2024 AASLD conference. Please reach out to set up a meeting or to learn more about the company. About Chemomab Therapeutics Ltd.Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a dual activity monoclonal antibody that neutralizes CCL24 activity. In clinical and preclinical studies, CM-101 has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of CM-101 in patients. Based on recent promising data from its Phase 2 trial in the rare liver disease primary sclerosing cholangitis (PSC), the company expects two upcoming milestones in early 2025, including FDA feedback on the design of its planned PSC Phase 3 registrational trial. CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC. Chemomab’s CM-101 program for the treatment of systemic sclerosis is Phase 2-ready with an open U.S. IND. For more information, visit www.chemomab.com. Contacts: Media and Investors:Barbara LindheimConsulting Vice President, Investor & Public Relations, Strategic CommunicationsPhone: +1 917-355-9234barbara.lindheim@chemomab.comIR@chemomab.com

Phase 2Fast TrackOrphan DrugClinical Result

01 Oct 2024

·www.globenewswire.com

Chemomab Therapeutics to Present at October 2024 Investor Conferences

TEL AVIV, Israel, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that senior management will participate in two upcoming investor conferences. Chemomab management will meet with investors at the Third Annual ROTH Healthcare Opportunities Conference at the Metropolitan Club in New York City on October 9, 2024, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will participate in a fireside chat with senior biotechnology analyst Michael Okunewitch at the Maxim Healthcare Virtual Summit on October 16, 2024 at 9:00 am ET. These conferences are by invitation only. A recording of the Maxim Healthcare Summit fireside chat will be available via a link on the Chemomab investor relations website after the conference completes. Chemomab Participation in Third Annual ROTH Healthcare Opportunities Conference Date:October 9, 2024Time:9:00 am ET - 5:00 pm ETVenue:Metropolitan Club, New York CityFormat:One-on-one meetings with investorsInformation:https://www.meetmax.com/sched/event_111103/conference_home.html Chemomab Participation in 2024 Maxim Healthcare Virtual Summit Date:October 16, 2024Time:9:00 am ETVenue:VirtualFormat:Fireside chat with CEO Dr. Adi MorLink:Recording will be available at investors.chemomab.com post-conference.Information:https://m-vest.com/events/healthcare-10152024 About Chemomab Therapeutics Ltd.Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a dual activity monoclonal antibody that neutralizes CCL24 activity. In clinical and preclinical studies, CM-101 has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of CM-101 in patients. Based on recent promising data from its Phase 2 trial in the rare liver disease primary sclerosing cholangitis (PSC), the company expects two upcoming milestones in early 2025, including FDA feedback on the design of its planned PSC Phase 3 registrational trial. CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC. Chemomab’s CM-101 program for the treatment of systemic sclerosis is Phase 2-ready with an open U.S. IND. For more information, visit www.chemomab.com. Contacts: Media and Investors:Barbara LindheimConsulting Vice President, Investor & Public Relations, Strategic CommunicationsPhone: +1 917-355-9234barbara.lindheim@chemomab.comIR@chemomab.com

Fast TrackPhase 2Clinical ResultOrphan Drug

100 Deals associated with Nebokitug

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Scleroderma, Systemic	Phase 2	US	Chemomab Ltd.	21 Feb 2023
Nonalcoholic Steatohepatitis	Phase 2	IL	Chemomab Ltd.	24 Feb 2021
Cholangitis, Sclerosing	Phase 2	DE	Chemomab Ltd.	01 Oct 2020
Cholangitis, Sclerosing	Phase 2	IL	Chemomab Ltd.	01 Oct 2020
Cholangitis, Sclerosing	Phase 2	ES	Chemomab Ltd.	01 Oct 2020
Cholangitis, Sclerosing	Phase 2	GB	Chemomab Ltd.	01 Oct 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04595825 (SPRING, PipelineReview) Manual	Phase 2	Cholangitis, Sclerosing	76	CM-101 10 mg/kg	uscbjwqhsk(rgmuexclvq) = Adverse events, which most commonly included fatigue, headache, and pruritis, were generally mild/moderate and distributed similarly between the placebo and CM-101-treated dosing arms. sziimoavbk (jrtolsvbzv ) Met View more	Positive	25 Jul 2024
				CM-101 20 mg/kg
NCT05824156 (AASLD2023) Manual	Phase 2	Nonalcoholic Steatohepatitis	23	CM-101 5mg/kg	fnjlgtttmj(vcdgclqisr) = significant reduction vzkoisarga (mogwlazpur ) View more	Positive	13 Nov 2023
				placebo

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