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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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Alexander Dömling1, Tad A Holak2

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Balinatunfib, an oral small molecule, effectively inhibits tumor necrosis factor alpha (TNFα) by stabilizing a non-functional trimer. This approach offers a promising alternative to biologics for treating inflammatory diseases.

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Area of Science:

  • Immunology
  • Pharmacology
  • Drug Discovery

Background:

  • Inflammatory responses are common in diseases, necessitating effective pharmacological treatments.
  • Tumor necrosis factor alpha (TNFα) is a critical cytokine in inflammatory and autoimmune conditions.
  • Current biologic TNFα inhibitors have limitations, including poor blood-brain barrier penetration and parenteral administration.

Purpose of the Study:

  • To evaluate the efficacy of the small molecule balinatunfib (SAR441566) as an oral therapeutic targeting TNFα.
  • To investigate the mechanism of action of balinatunfib in stabilizing TNFα into a receptor-incompetent conformation.
  • To compare the anti-inflammatory effects of balinatunfib with existing biologic therapies in preclinical models.

Main Methods:

  • Development of an orally available small molecule, balinatunfib, designed to allosterically inhibit TNFα.
  • Utilizing preclinical models to assess the anti-inflammatory efficacy and mechanism of action of balinatunfib.
  • Evaluating the ability of balinatunfib to prevent TNFα receptor binding and downstream signaling.

Main Results:

  • Balinatunfib demonstrated comparable anti-inflammatory effects to biologic therapies in preclinical models.
  • The small molecule successfully stabilized TNFα in a distorted, receptor-incompetent trimer conformation.
  • Oral administration of balinatunfib offers potential advantages for patient compliance and CNS accessibility.

Conclusions:

  • Small molecules can achieve high-affinity, conformation-based inhibition of TNFα.
  • Balinatunfib represents a novel therapeutic strategy for managing TNFα-mediated inflammatory diseases.
  • Orally administered small molecules targeting TNFα may offer a new class of treatments with improved accessibility and compliance.