Celldex May Have Best Efficacy In Chronic Spontaneous Urticaria

Sanofi Also Succeeds With BTKi In Phase II

Looking to treat patients with CSU uncontrolled by Xolair, Celldex’s KIT binder barzolvolimab shows strong disease activity reduction at 12 weeks in Phase II. Sanofi’s BTK inhibitor rilzabrutinib also showed efficacy in CSU.

Urticaria
Both Celldex and Sanofi hope to challenge Xolair in CSU • Source: Shutterstock

With multiple companies looking to address treatment shortcomings in chronic spontaneous urticaria (CSU) with standard of care Xolair, Celldex Therapeutics, Inc. presented Phase II data at the American Academy of Allergy, Asthma and Immunology annual meeting on 25 February that some analysts said suggest a best-in-class profile for the disease. Celldex is planning to take its drug, barzolvolimab, a binder of receptor tyrosine kinase KIT, into Phase III for CSU later this year, while awaiting 52-week data from the Phase II study.

Key Takeaways

  • In presentations at the AAAI meeting, Celldex and Sanofi both unveiled Phase II data for candidates that might offer efficacy in chronic spontaneous urticaria for patients whose disease is uncontrolled on Xolair.

Meanwhile, Sanofi, months after a US Food and Drug Administration complete response letter delayed its effort to add CSU...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By 

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D