HAMPTON, NJ, USA I May 15, 2023 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced preclinical data from CDX-622, the Company’s bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF have been shown to contribute to the pathophysiology of various inflammatory, fibrotic and allergic disorders. These data were presented in a poster session as part of IMMUNOLOGY2023™, the annual meeting of the American Association of Immunologists (AAI).

The preclinical data show CDX-622 potently neutralizes the alarmin TSLP, a potent mediator of inflammation, and blocks SCF/KIT interaction required for mast cell function and survival. CDX-622 was well tolerated and demonstrated a favorable pharmacokinetic profile as well as robust evidence of skin mast cell depletion in preclinical models. The biophysical and functional characteristics of CDX-622 support the initiation of development activities including manufacturing and IND-enabling studies.

“Clinical studies with our KIT antibody, barzolvolimab, have demonstrated the significant potential of mast cell depletion through the inhibition of KIT. CDX-622 builds on this understanding and adds a second critical inflammatory pathway—TLSP mediated inflammation,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “The data presented at AAI demonstrate that we have successfully combined blockade of these two complementary inflammatory pathways into one molecule and support the further advancement of CDX-622, which we believe provides a unique opportunity to target multiple pathways in disease settings where using combination therapies is challenging.”

In the preclinical data presented at IMMUNOLOGY 2023, CDX-622 demonstrated potent inhibition of TSLP and SCF with a similar potency as comparator monoclonal antibodies in vitro. CDX-622 was shown to have monoclonal antibody-like biophysical and pharmacokinetic characteristics. The data also demonstrated strong evidence of skin mast cell depletion, consistent with the expected role of SCF/KIT in mast cell survival. Simultaneous inhibition of TSLP and mast cells with CDX-622 may result in improved efficacy over approaches targeting single pathways in inflammatory, fibrotic and allergic disorders.

The poster presented at IMMUNOLOGY2023™ can be viewed on the “Publications” page of the “Science” section of the Celldex website.

About CDX-622
CDX-622 is a bispecific antibody developed from novel humanized antibodies specific for TSLP and SCF. CDX-622 combines blockade of the alarmin TSLP with mast cell inhibition through SCF neutralization. Combined blockade of these non-redundant pathways that drive inflammation may lead to enhanced clinical activity in certain inflammatory, fibrotic and allergic disorders.

About Celldex’s Bispecific Antibody Platform
Celldex’s deep antibody experience and in-house manufacturing capabilities support efficient development of next generation bispecific antibody programs for inflammatory/autoimmune diseases and oncology. Bispecific antibodies can engage two independent pathways involved in controlling immune reactions and can overcome challenges associated with combination treatment approaches. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody formats with Celldex’s existing antibody programs.

About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. 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 inflammatory diseases and many forms of cancer. Visit www.celldex.com.

SOURCE: Celldex Therapeutics