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Celldex Therapeutics, Inc. (CLDX)

Celldex Therapeutics, Inc. is a biopharmaceutical company dedicated to developing antibody-based treatments, specifically monoclonal and bispecific antibodies, for a range of diseases. Their pipeline features therapeutic candidates aimed at both inflammatory conditions and various forms of cancer. Among their key clinical programs: CDX-0159 is a Phase I monoclonal antibody designed to bind to and inhibit the activity of the KIT receptor tyrosine kinase. CDX-1140 is a human agonist monoclonal antibody that targets CD40, a critical immune response activator found on immune cells such as dendritic cells, macrophages, and B cells, as well as on several cancer cell types. CDX-527 is a bispecific antibody that integrates Celldex's proprietary anti-PD-L1 and CD27 human antibodies. Its mechanism involves combining CD27 costimulation with blockade of the PD-L1/PD-1 pathway to prime and activate anti-tumor T-cell responses. The company has established several research collaborations and licensing agreements, including partnerships with the University of Southampton for developing human antibodies targeting CD27, Amgen Inc. for exclusive rights to CDX-301 and CD40 ligand, and Yale University. Incorporated in 1983, Celldex Therapeutics, Inc. is headquartered in Hampton, New Jersey.

Sector: In Vitro & In Vivo Diagnostic Substances

Industry: Biotechnology

Celldex Therapeutics, Inc. logo

Celldex Therapeutics, Inc.

NASDAQ:CLDXHealthcare
+0.70%$30.10
AH$30.10+0.00%vs close
Mkt Cap$2.36B
Float73.98M
O/S78.53M
Vol
$ Vol
RVOL
Inst Own-
SI13.0%
Earnings
Dilution
Celldex Therapeutics, Inc. logoNASDAQ:CLDX$30.10+0.70%
Phase Distribution
47 lead-sponsored trials·7 active·29 completed
Phase 122
Phase 1/23
Phase 215
Phase 35
Not applicable2
(25 more as collaborator)
Status Overview
Recruiting3
Active, not recruiting4
Completed29
Stopped9
Expanded access2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

    Rindopepimut (CDX-110) with GM-CSF, Temozolomide

    Glioblastoma, Small Cell Glioblastoma +3

    Enrollment
    745
    Start
    Nov 2011
    Primary Completion
    Nov 2016
    Completion
    Nov 2016
    NCT01480479
  • Phase 3
    Active, not recruiting

    A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

    barzolvolimab, Matching placebo

    Chronic Spontaneous Urticaria

    Enrollment
    963
    Start
    Jul 2024
    Primary Completion
    Oct 2026est.
    Completion
    Apr 2027est.
    NCT06445023
  • Phase 3
    Active, not recruiting

    A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

    barzolvolimab, Matching placebo

    Chronic Spontaneous Urticaria

    Enrollment
    976
    Start
    Jul 2024
    Primary Completion
    Oct 2026est.
    Completion
    Apr 2027est.
    NCT06455202
  • Phase 3
    Enrolling by invitation

    Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

    barzolvolimab

    Chronic Spontaneous Urticaria

    Enrollment
    1,370
    Start
    Nov 2025
    Primary Completion
    Sep 2028est.
    Completion
    Sep 2028est.
    NCT07256392
  • Phase 3
    Recruiting

    A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

    Barzolvolimab, Matching Placebo

    Chronic Inducible Urticaria, Cold Urticaria +2

    Enrollment
    240
    Start
    Jan 2026
    Primary Completion
    Jun 2028est.
    Completion
    Oct 2028est.
    NCT07266402
  • Phase 2
    Completed

    Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery

    TP10

    Myocardial Ischemia, Coronary Arteriosclerosis +2

    Enrollment
    300
    Start
    Apr 2004
    Primary Completion
    -
    Completion
    Dec 2005
    NCT00082121
  • Phase 2
    Completed

    Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

    CDX-110 with GM-CSF, Temozolomide

    Malignant Glioma

    Enrollment
    82
    Start
    Aug 2007
    Primary Completion
    Nov 2010
    Completion
    May 2016
    NCT00458601
  • Phase 2
    Completed

    Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

    Ty800 (Salmonella typhi) Oral Vaccine

    Typhoid Fever

    Enrollment
    180
    Start
    Jul 2007
    Primary Completion
    Oct 2007
    Completion
    Jun 2008
    NCT00498654
  • Phase 2
    Terminated

    A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)

    CDX-1307 Vaccine Regimen, Chemotherapy

    Bladder Cancer

    Enrollment
    3
    Start
    Apr 2010
    Primary Completion
    Jul 2011
    Completion
    Jul 2011
    NCT01094496
  • Phase 2
    Completed

    A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer

    CDX-011, "Investigator's Choice" chemotherapy

    Breast Cancer

    Enrollment
    120
    Start
    Jul 2010
    Primary Completion
    Oct 2012
    Completion
    Nov 2012
    NCT01156753
  • Phase 2
    Completed

    A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

    Bevacizumab, Rindopepimut (CDX-110) with GM-CSF

    Glioblastoma, Small Cell Glioblastoma +5

    Enrollment
    127
    Start
    Dec 2011
    Primary Completion
    Apr 2015
    Completion
    May 2016
    NCT01498328
  • Phase 2
    Completed

    Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

    CDX-011, Capecitabine

    Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

    Enrollment
    327
    Start
    Nov 2013
    Primary Completion
    Nov 2017
    Completion
    Aug 2018
    NCT01997333
  • Phase 2
    Terminated

    A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs

    CDX-301, CDX-301 and plerixafor

    For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling +8

    Enrollment
    36
    Start
    Jul 2014
    Primary Completion
    Mar 2016
    Completion
    Apr 2016
    NCT02200380
  • Phase 2
    Terminated

    A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma

    glembatumumab vedotin, glembatumumab vedotin and varlilumab

    Melanoma

    Enrollment
    132
    Start
    Nov 2014
    Primary Completion
    Jun 2018
    Completion
    Oct 2018
    NCT02302339
  • Phase 2
    Terminated

    A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

    CDX-3379 and cetuximab

    Advanced Head and Neck Squamous Cell Carcinoma

    Enrollment
    30
    Start
    Mar 2018
    Primary Completion
    Sep 2020
    Completion
    Dec 2020
    NCT03254927
  • Phase 2
    Completed

    A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

    barzolvolimab, Matching Placebo

    Chronic Spontaneous Urticaria

    Enrollment
    208
    Start
    May 2022
    Primary Completion
    Sep 2023
    Completion
    Dec 2024
    NCT05368285
  • Phase 2
    Completed

    A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

    barzolvolimab, Matching Placebo

    Chronic Inducible Urticaria

    Enrollment
    196
    Start
    Jun 2022
    Primary Completion
    Jun 2024
    Completion
    Sep 2025
    NCT05405660
  • Phase 2
    Completed

    A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

    barzolvolimab, Matching Placebo

    Eosinophilic Esophagitis

    Enrollment
    86
    Start
    Jun 2023
    Primary Completion
    Jun 2025
    Completion
    Jan 2026
    NCT05774184
  • Phase 2
    Active, not recruiting

    A Study of Barzolvolimab in Patients With Prurigo Nodularis

    barzolvolimab

    Prurigo Nodularis

    Enrollment
    140
    Start
    Apr 2024
    Primary Completion
    Mar 2026
    Completion
    Mar 2027est.
    NCT06366750
  • Phase 2
    Active, not recruiting

    A Study of Barzolvolimab in Patients With Atopic Dermatitis

    Barzolvolimab, Matching placebo

    Atopic Dermatitis

    Enrollment
    131
    Start
    Dec 2024
    Primary Completion
    May 2026
    Completion
    Dec 2026est.
    NCT06727552
  • Phase 1/2
    Completed

    A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

    CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401

    Advanced Malignancies

    Enrollment
    70
    Start
    Sep 2009
    Primary Completion
    Jun 2012
    Completion
    Feb 2014
    NCT00948961
  • Phase 1/2
    Completed

    A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

    Combination of varlilumab and nivolumab

    Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed +3

    Enrollment
    175
    Start
    Jan 2015
    Primary Completion
    Dec 2018
    Completion
    Dec 2018
    NCT02335918
  • Phase 1/2
    Terminated

    A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma

    Combination of varlilumab and ipilimumab, Cohort A: varlilumab & ipilimumab; Cohort B: varlilumab, ipilimumab, CDX-1401 & poly-ICLC

    Unresectable Stage III or Stage IV Melanoma

    Enrollment
    9
    Start
    Apr 2015
    Primary Completion
    Nov 2016
    Completion
    Nov 2016
    NCT02413827
  • Phase 1
    Completed

    Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer

    CDX-1307

    Breast Cancer, Colorectal Cancer +3

    Enrollment
    36
    Start
    Jan 2006
    Primary Completion
    May 2009
    Completion
    Dec 2009
    NCT00648102
  • Phase 1
    Completed

    A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)

    CDX1307

    Breast Cancer, Colorectal Cancer +3

    Enrollment
    48
    Start
    Mar 2004
    Primary Completion
    May 2010
    Completion
    Jun 2010
    NCT00709462

1-25 of 47

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