Celldex Therapeutics, Inc. is at the forefront of developing innovative antibody therapeutics, particularly focusing on mast cell biology. Their lead program, barzolvolimab (CDX-0159), is a humanized monoclonal antibody that specifically targets the receptor tyrosine kinase KIT, which is crucial for mast cell function and survival. By inhibiting KIT, barzolvolimab aims to address various severe inflammatory, allergic, and autoimmune diseases where mast cell activation plays a significant role. The company is actively pursuing clinical trials for conditions such as chronic spontaneous urticaria, chronic inducible urticaria, prurigo nodularis, and eosinophilic esophagitis, highlighting their commitment to improving patient outcomes in these challenging areas.

In addition to barzolvolimab, Celldex is advancing a bispecific antibody platform designed to tackle complex inflammatory and autoimmune diseases by engaging multiple immune pathways. One of their bispecific candidates, CDX-622, targets both thymic stromal lymphopoietin (TSLP) and KIT, aiming to neutralize inflammatory responses while depleting mast cells. This dual-action approach is expected to enhance therapeutic benefits in treating chronic inflammation and fibrotic disorders. Celldex's robust in-house capabilities and extensive experience in antibody development support their mission to create transformative therapies that address unmet medical needs in various therapeutic areas.

United States

Celldex Therapeutics (NASDAQ: CLDX) was founded based on a fundamental scientific belief that harnessing the power of the immune system would break significant barriers in drug development for a host of devastating diseases. The Company’s pipeline is comprised of therapeutic antibodies, antibody-drug conjugates, immune system modulators and other protein-based therapeutics that we believe have a higher probability of success because they are targeted to specific patient populations with high unmet medical need whose diseases express specific markers—including many underserved or completely un-served orphan indications.

Cancer

Digestive System Diseases

Hematologic Diseases

Inflammatory disorders

Celldex Therapeutics, Inc.

Chronic spontaneous urticaria

Chronic urticaria

KIT/Mast cell diseases

CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. &nbsp;In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease.

Barzolvolimab (CDX-0159) (KIT receptor) 

Chronic inducible urticaria

Barzolvolimab (CDX-0159)

Prurigo nodularis

Skin disease/disorder

Eosinophilic Esophagitis

Eosinophilic Gastritis

Atopic dermatitis

Barzolvolimab (CDX-0159) (KIT receptor)  

Solid tumor/s

CDX-585 is a dual targeting PD-1/ILT4 bispecific antibody from Celldex’s bispecific antibody platform. Expression of ILT4 in several tumor types is associated with poor outcome and in preclinical models, antagonist antibodies to ILT4 have demonstrated immune enhancing and antitumor effects. Preclinical studies have shown that CDX-585 is a potent antagonist of both PD-1 and ILT4, and CDX-585 is more potent than the combination of PD-1 and ILT-4 mAbs in several model systems. CDX-585 is being developed as part of a research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.

CDX-585

Inflammatory disease

CDX-622 – Bispecific SCF &amp; TSLP, CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders.

CDX-622

CDX-527 is the first candidate from Celldex’s bispecific antibody platform. It uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 costimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response. The Company believes that the potential for CDX-527 will include both monotherapy and combination studies with other immunotherapies or conventional cancer treatments.

CDX-527 (and PD-L1 / CD27)

Diffuse large B cell lymphoma

CDX-1140 is a fully human antibody targeted to CD40, a key activator of immune response which is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40L binding is not blocked, leading to potential synergistic effects of agonist activity near activated T cells in lymph nodes and tumors; and the antibody does not promote cytokine production in whole blood assays

Celldex Therapeutics, Inc.

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