CDX-622 / Celldex - LARVOL DELTA

Celldex Presents Positive First-in-Human Results from Phase 1 Study of Novel Bispecific CDX-622 at the European Academy of Allergy and Clinical Immunology Annual Meeting (GlobeNewswire) - "Rapid, profound, dose-dependent, and durable reductions in serum tryptase were observed, indicative of tissue mast cell inhibition and depletion:Tryptase decreases were comparable to KIT-targeting following multiple doses; Biopsy data were consistent with greater impact on mucosal mast cells than skin mast cells; CDX-622 exhibited monoclonal antibody-like pharmacokinetics, with extended half-life and good exposure with subcutaneous administration, consistent with good bioavailability: There was no evidence of immunogenicity at any dose; CDX-622 was well-tolerated in all study parts and at all dose levels. There were no dose-limiting toxicities or related serious adverse events."

First-in-human • P1 data • Allergy • Immunology • Inflammation

Celldex Announces Multiple Upcoming Presentations from Leading Mast Cell Targeting Pipeline at the Upcoming 2026 European Academy of Allergy and Clinical Immunology Annual Congress (GlobeNewswire) - "Results supporting Celldex’s leadership and barzolvolimab’s first-in-class, best-in-disease profile in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) will be presented in two flash talks. New, first-in-human results from the Phase 1 trial of the novel bispecific CDX-622 in healthy volunteers will be presented in a late-breaking poster session, highlighting the potential for bispecific targeting of soluble stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP) to inhibit KIT signaling in mast cells."

Clinical data • Late-breaking abstract • Chronic Spontaneous Urticaria • Inflammation • Urticaria

Phase 1 study of CDX-622, a bispecific antibody targeting TSLP and mast cells via stem cell factor (EAACI 2026) - P1 | "CDX-622 represents the first molecule that depletes mast cells via SCF neutralization to enter human clinical trials. Combined TSLP neutralization and MC depletion with CDX-622 may result in broader efficacy in inflammatory diseases where both pathways play a pathogenic role."

Bispecific • P1 data • Immunology • Inflammation • TSLP

A Study of CDX-622 in Participants With Mild to Moderate Asthma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Celldex Therapeutics | Initiation date: Feb 2026 ➔ Jun 2026

Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

CDX-622 – Bispecific SCF & TSLP (Celldex Press Release) - "Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026."

P1 data • Immunology

CDX622-01: A Phase I Study of CDX-622 (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Celldex Therapeutics | Active, not recruiting ➔ Completed

Trial completion

CDX622-01: A Phase I Study of CDX-622 (clinicaltrials.gov) - P1 | N=85 | Active, not recruiting | Sponsor: Celldex Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of CDX-622 in Participants With Mild to Moderate Asthma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Celldex Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of CDX-622 in Participants With Mild to Moderate Asthma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Celldex Therapeutics

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Bispecific Antibody Platform: CDX-622 - Bispecific SCF & TSLP (GlobeNewswire) - "Enrollment is ongoing in the Phase 1 study in healthy volunteers....Patients are now being enrolled to Part 2 of the study with data anticipated in Q3 2026."

Enrollment status • P1 data • Immunology • Inflammation

Celldex Announces Initial Positive Results from Phase 1 Trial of CDX-622 Demonstrating Favorable Safety and PK Profile and Sustained Mast Cell Inhibition (GlobeNewswire) - "The data were presented by Diego Alvarado, PhD, Vice President of Research at Celldex, in an oral presentation at the CIA (Collegium Internationale Allergologicum) Biennial Symposium in Dubrovnik, Croatia...CDX-622 preferentially inhibits the soluble form of SCF over the membrane form, which may lead to differential impact on KIT-dependent processes; In a GLP toxicology study, the No-Observed-Adverse-Effect-Level (NOAEL) was the highest dose level tested (75 mg/kg) and led to profound mast cell depletion in the tissues; In healthy participants, CDX-622 was well tolerated with no dose limiting toxicities, serious adverse events, or infusion reactions and no emergent events related to systemic KIT inhibition; CDX-622 exhibited mAb-like pharmacokinetics (serum half-life of approximately 18 days at 9 mg/kg) without any evidence of antidrug antibodies (ADA)."

P1 data • PK/PD data • Immunology

CDX622-01: A Phase I Study of CDX-622 (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Celldex Therapeutics | N=56 ➔ 80 | Trial completion date: Jan 2026 ➔ Apr 2026 | Trial primary completion date: Jan 2026 ➔ Apr 2026

Enrollment change • Trial completion date • Trial primary completion date

Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Enrollment is ongoing in the Phase 1 study in healthy volunteers. This two-part randomized, double-blind, placebo-controlled, dose escalation study is designed to assess the safety, pharmacokinetics, and pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. Data from Part 1 of the study are expected in 2H 2025."

P1 data • Trial status • Immunology • Inflammation

CDX-622 – Bispecific SCF & TSLP (GlobeNewswire) - "Enrollment is ongoing in the Phase 1 study in healthy volunteers. This two-part randomized, double-blind, placebo-controlled, dose escalation study is designed to assess the safety, pharmacokinetics, and pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. Data from Part 1 of the study is expected in 2025."

Enrollment status • P1 data • Immunology • Inflammation

Celldex Therapeutics Presents Positive Preclinical Data from Inflammatory Bispecific Antibody Program CDX-622 at AAAAI 2025 (GlobeNewswire) - "In the poster presented, preclinical studies demonstrate that CDX-622: Inhibits TSLP and SCF-dependent activities in vitro with similar potency as its parental mAbs as well as tezepelumab and barzolvolimab; Preferentially inhibits the soluble over the membrane form of SCF, which may lead to differential impact on KIT-dependent processes; Inhibits both SCF and TSLP-dependent inflammatory signatures in a human skin explant model; Exhibits mAb-like PK properties and leads to significant reduction in skin mast cell signatures."

Preclinical • Fibrosis • Inflammation

CDX-622 – Bispecific SCF & TSLP (GlobeNewswire) - "A Phase 1 study in healthy volunteers was initiated in November 2024 and enrollment is ongoing. This two-part randomized, double-blind, placebo-controlled, Phase 1 dose escalation study is designed to assess the safety, pharmacokinetics, and pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP."

Enrollment status • Immunology • Inflammation

Dual Inhibition of Mast Cells and Thymic Stromal Lymphopoietin Using a Novel Bispecific Antibody, CDX-622. (PubMed, Allergy) - "CDX-622 is a potent inhibitor of MCs through the neutralization of SCF and effectively blocks Type 2 inflammatory responses driven by TSLP. Dual inhibition of these cytokines may lead to improved clinical outcomes in certain inflammatory disorders."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

Dual targeting of mast cells and TSLP with the bispecific antibody CDX-622 (AAAAI-WAO 2025) - "CDX-622 represents the first molecule with potent SCF neutralizing properties to enter human trials. Combined TSLP neutralization and MC depletion with CDX-622 may result in broader efficacy in inflammatory diseases where both pathways play a pathogenic role."

Inflammation • KIT • TSLP

CDX622-01: A Phase I Study of CDX-622 (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Celldex Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase I Study of CDX-622 (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Celldex Therapeutics

New P1 trial