Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 498 |
| INN | Barzolvolimab |
| Status | Clinical |
| Drug code(s) | CDX-0159 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | c-Kit |
| Indications of clinical studies | Eosinophilic Esophagitis, Chronic Inducible Urticaria, Prurigo nodularis, Chronic Spontaneous Urticaria, Phase 1 in healthy volunteers (intended to treat CIU, a mast cell-related disease) |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2019 |
| Start of Phase 2 | May 15, 2022 |
| Start of Phase 3 | July 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Celldex |
| Licensee/Partner | None |
| Comments about company or candidate | July 16, 2024: Celldex Therapeutics, Inc. announced today the initiation of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies will also include patients who remain symptomatic after treatment with biologics. https://ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-initiates-global-phase-3-program NCT06455202 Phase 3 study in Chronic Spontaneous Urticaria due to start in July 2024 NCT06445023 Phase 3 study in Chronic Spontaneous Urticaria due to start in July 2024. May 15, 2024: Celldex Therapeutics, Inc. announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis. https://www.globenewswire.com/news-release/2024/05/15/2882402/24180/en/Celldex-Announces-First-Patient-Dosed-in-Phase-2-Study-of-Barzolvolimab-in-Prurigo-Nodularis.html NCT05774184 Phase 2 in EE to start in May 2023. NCT05368285 Phase 2 in Chronic Spontaneous Urticaria started in May 2022. Feb 2021: Celldex Therapeutics, Inc announced that the Company will expand clinical development of CDX-0159 into prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. NCT04548869 is An Open Label, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add on Therapy in Patients With Cold Contact Urticaria and Symptomatic Dermographism. NCT04538794 is a Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria Nov 11, 2019 press release: Celldex’s Investigational New Drug (IND) Application for CDX-0159 has been accepted by the Food and Drug Administration and the Company plans to initiate a Phase 1a study of CDX-0159 by year-end 2019. Oct 2019: NCT04146129 Phase 1 in healthy volunteers. Aug 2019: Celldex plans to submit an Investigation New Drug (IND) Application and initiate a Phase 1a study of CDX-0159 by year-end 2019. The study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, the Company plans to further study CDX-0159 in CIU, a mast cell-related disease. Given the infusion reactions, modifications have been introduced into the Fc portion of the CDX-0158 antibody to prevent these interactions and increase the half-life of the antibody. This second-generation version, called CDX-0159, has demonstrated equivalent KIT inhibition to CDX-0158 in preclinical studies, but unlike CDX-0158, CDX-0159 does not induce KIT activation when Fc receptors are used to cross-link the antibodies. CDX-0159 is being fully developed in-house with the intention of replacing CDX-0158 in clinical development. |
| Full address of company | 53 Frontage Road, Suite 220, Hampton, NJ 08827 North America United States of America https://celldex.com/company/contact/ |
CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |