HAMPTON, NJ, USA I November 20, 2024 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that 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.
“The introduction of our first bispecific candidate for inflammatory diseases, CDX-622, builds on our leadership in mast cell biology,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “CDX-622 combines mast cell depletion with inhibition of Type 2 inflammatory responses and could be broadly applicable across a wide range of respiratory and dermatological disorders. Upon successful completion of this study in healthy volunteers, we look forward to building a robust pipeline beginning initially with a study in asthma. Importantly, we believe CDX-622 complements our barzolvolimab program, further strengthening our existing pipeline which is now advancing across five diseases.”
TSLP has been directly implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique SCF neutralizing function that is expected to inhibit and deplete mast cells. 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.
The Phase 1a clinical trial is a two-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of
of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. A single dose of CDX-622 or placebo will be administered intravenously once during Part 1. In Part 2, CDX-622 or placebo will be administered every 3 weeks (Q3W) for up to 6 weeks following the first dose, for a total of 3 doses. Participants will be followed for 12 weeks in both Parts 1 and 2 following the last dose of study drug. Celldex will also assess blood and skin biomarkers associated with and related to SCF and TSLP signaling and other immune inflammatory pathways in healthy participants as exploratory endpoints. A subcutaneous formulation is currently being manufactured and will be added to this study in 2025.
For additional information on this trial (NCT06650761), please visit www.clinicaltrials.gov.
About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 4,428
HAMPTON, NJ, USA I November 20, 2024 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that 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.
“The introduction of our first bispecific candidate for inflammatory diseases, CDX-622, builds on our leadership in mast cell biology,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “CDX-622 combines mast cell depletion with inhibition of Type 2 inflammatory responses and could be broadly applicable across a wide range of respiratory and dermatological disorders. Upon successful completion of this study in healthy volunteers, we look forward to building a robust pipeline beginning initially with a study in asthma. Importantly, we believe CDX-622 complements our barzolvolimab program, further strengthening our existing pipeline which is now advancing across five diseases.”
TSLP has been directly implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique SCF neutralizing function that is expected to inhibit and deplete mast cells. 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.
The Phase 1a clinical trial is a two-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of
of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. A single dose of CDX-622 or placebo will be administered intravenously once during Part 1. In Part 2, CDX-622 or placebo will be administered every 3 weeks (Q3W) for up to 6 weeks following the first dose, for a total of 3 doses. Participants will be followed for 12 weeks in both Parts 1 and 2 following the last dose of study drug. Celldex will also assess blood and skin biomarkers associated with and related to SCF and TSLP signaling and other immune inflammatory pathways in healthy participants as exploratory endpoints. A subcutaneous formulation is currently being manufactured and will be added to this study in 2025.
For additional information on this trial (NCT06650761), please visit www.clinicaltrials.gov.
About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 4,428
