Celldex Therapeutics Inc.

CLDX

Held by 11 specialist biotech funds

High Convergence

11 funds opened new positions. Next phase2 readout (Human CMV pp65-LAMP mRNA-pulsed autologous DCs): Mar 2026. Short interest: 16.6% of float.

BiotechnologyCEO: Anthony S. MarucciIPO: 1986Website ↗

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.

Catalysts

Phase 2Q4 2010CDX-110 with GM-CSFMalignant GliomaNCT00458601

Primary: Progression-free survival status (5.5mo)Enrollment:82/82Sites: 34NA, TREATMENT

Phase 2NegativeQ3 2011CDX-1307 Vaccine RegimenBladder CancerNCT01094496

Primary: 2 year Recurrence-Free Survival Rate (2 years following enrollment)Enrollment:3/3Sites: 17NA, TREATMENT

Phase 2NegativeQ1 2016CDX-301For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, For RecipientsNCT02200380

Primary: Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors. (1 Year)Enrollment:36/36Sites: 8NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ4 2016Rindopepimut (CDX-110) with GM-CSFGlioblastoma, Small Cell Glioblastoma, Giant Cell GlioblastomaNCT01480479

Primary: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)Enrollment:745/745Sites: 223RANDOMIZED, TRIPLE, TREATMENT

Phase 2NegativeQ2 2018glembatumumab vedotinMelanomaNCT02302339

Phase 2Q4 2018Combination of varlilumab and nivolumabSquamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed, Colorectal Cancer (CRC)-Enrollment CompletedNCT02335918

Primary: Phase I: Number of participants with treatment-related adverse events as determined by CTCAE v4.0, dose-limiting toxicities, and laboratory abnormalities. (Safety follow-up is 100 days from last study drug dose.)Enrollment:175/175Sites: 19NA, TREATMENT

Phase 2NegativeQ3 2020CDX-3379 and cetuximabAdvanced Head and Neck Squamous Cell CarcinomaNCT03254927

Primary: Objective Response Rate (The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.)Enrollment:30/30Sites: 10NA, TREATMENT

Phase 2Q3 2023barzolvolimabChronic Spontaneous UrticariaNCT05368285

Phase 2Q2 2024barzolvolimabChronic Inducible UrticariaNCT05405660

Phase 2Q2 2025barzolvolimabEosinophilic EsophagitisNCT05774184

Phase 2Q1 2026Human CMV pp65-LAMP mRNA-pulsed autologous DCsGlioblastomaNCT03688178

Primary: Median Overall Survival (OS) of Subjects Receiving Td pre-conditioning (5 years)Enrollment:43/43Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q2 2026BarzolvolimabAtopic DermatitisNCT06727552

Primary: Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16 (From Day 1 (first dose) to Day 113 (week 16))Enrollment:131/131Sites: 33RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2026barzolvolimabPrurigo NodularisNCT06366750

Primary: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. (From Day 1 (first dose) to Day 85 (week 12))Enrollment:140/140Sites: 72RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2026barzolvolimabChronic Spontaneous UrticariaNCT06445023

Primary: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (From Day 1 (first dose) to Day 85 (Week 12))Enrollment:963/963Sites: 235RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2026barzolvolimabChronic Spontaneous UrticariaNCT06455202

Primary: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (From Day 1 (first dose) to Day 85 (Week 12))Enrollment:976/976Sites: 245RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Dec 30, 2026Anti-CD40 Agonist Monoclonal Antibody CDX-1140Ovarian Clear Cell Adenocarcinoma, Platinum-Sensitive Ovarian Carcinoma, Recurrent Endometrial Serous AdenocarcinomaNCT05231122

Primary: Incidence of adverse events (Up to 2 years)Enrollment:Target 80Sites: 2RANDOMIZED, SINGLE, TREATMENT

Phase 2Dec 31, 2026Pembrolizumab (200mg IV for 30 minutesBreast CancerNCT03804944

Primary: Tolerability will be demonstrated if no grade 3 or higher toxicities are observed in the first 8 patients, of each arm. (3 years)Enrollment:Target 100Sites: 8RANDOMIZED, TREATMENT

Phase 3Q2 2028BarzolvolimabChronic Inducible Urticaria, Cold Urticaria, Cold-Induced UrticariaNCT07266402

Phase 3Q3 2028barzolvolimabChronic Spontaneous UrticariaNCT07256392

Celldex Therapeutics Inc.

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