inflammation
ProgramProg
PreclinicalPre
Phase 1Ph1
Phase 2Ph2
Phase 3Ph3

Barzolvolimab (CDX-0159) KIT Antagonist mAb

Barzolvolimab (CDX-0159) KIT Antagonist mAb

Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU)CSU
Chronic Inducible Urticaria (CIndU)
Chronic Inducible Urticaria (CIndU)CIndU
Prurigo nodularis (PN)
Prurigo nodularis (PN)PN
Eosinophilic esophagitis (EoE)
Eosinophilic esophagitis (EoE)EoE
bispecific platform - Next Generation Inflammatory & Oncology
ProgramProg
PreclinicalPre
Phase 1Ph1
Phase 2Ph2
Phase 3Ph3

CDX-527 PD-L1 & CD27

CDX-527 PD-L1 & CD27

Ovarian cancer
Ovarian cancerOvarian cancer

CDX-585 PD-1 & ILT4

CDX-585 PD-1 & ILT4

Solid Tumors
Solid TumorsSolid Tumors

Preclinical
SCF/KIT

Preclinical
SCF/KIT

Inflammatory/autoimmune
Inflammatory/autoimmuneInflammatory/autoimmune

Therapeutic Areas

Celldex is currently developing antibody therapies for diseases with mast cell involvement, including chronic allergic/inflammatory disorders and autoimmune diseases.

Barzolvolimab (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. In certain inflammatory diseases, mast cell activation plays a central role in the onset and progression of the disease.

Chronic urticarias (Hives/Wheals)

Urticarias are red, itchy hives/wheals that result from an inflammatory skin reaction that are driven by activation of the mast cells in the skin. The condition is considered chronic if the hives appear for more than six weeks and recur frequently over months or years. These diseases can be severe and debilitating with a significant impact on quality of life and limited treatment options. Chronic urticarias can be inducible (caused by a specific trigger) or spontaneous (no known cause).

Chronic inducible urticaria (CIndU)

CindU is characterized by the occurrence of hives/wheals that are associated with a specific cause or trigger. The three most common triggers include: physical contact with the skin known as Symptomatic Dermographism (SD), cold or below body temperatures known as Cold Urticaria (CU) and sweating/ increases in body temperature known as Cholinergic Urticaria (CholU). Patients suffer both physically and psychologically with impaired quality of life.

Chronic spontaneous urticaria (CSU)

CSU is characterized by the occurrence of hives/wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin (release of histamines, leukotrienes, chemokines) results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. Current therapies provide symptomatic relief only in some patients.

Prurigo nodularis (PN)

PN is a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. Intense itching (pruritus) causes people to scratch themselves to the point of bleeding or pain – scratching can cause more skin lesions to appear, perpetuating the disease cycle. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation. PN causes a significant quality of life impact: sleep disturbance, psychological distress, social isolation, anxiety, depression.

Eosinophilic esophagitis (EoE)

EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils. Chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the esophagus – a medical emergency. Currently, there are limited treatment options for EoE.

Other mast cell driven diseases

Celldex is currently examining multiple mast cell driven diseases to potentially expand the development of CDX-0159. These include dermatologic, respiratory, gastrointestinal, allergic and ophthalmic conditions.

Complex diseases such as cancer, inflammatory and autoimmune all involve multiple immune pathways - bispecific antibodies can engage two independent pathways involved in controlling immune reactions. Celldex’s deep antibody experience and in-house manufacturing capabilities support efficient development of targets which are selected based on new science as well as their compatibility to be used in bispecific antibody formats with our existing antibody programs.

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.

CDX-527 is being investigated in advanced solid tumors, including:

Ovarian Cancer

Ovarian cancer originates in the cells of the ovaries, including surface epithelial cells, germ cells and the sex cord-stromal cells. Epithelial ovarian cancer is the most common type and accounts for 85–89% of ovarian cancers. It forms on the surface of the ovary in the epithelial cells or from the fallopian tube. It ranks fourth in cancer deaths among women and causes more deaths than any other cancer of the female reproductive system.

CDX-585 combines Celldex’s proprietary highly active PD-1 blockade and anti-ILT4 blockade to block immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells. CDX-585 is currently completing CMC and IND-enabling activities and is expected to enter the clinic in 2023.