Potential Best-in-Class Next Generation Anti-CD40L Antibody
AT-1501 is a humanized IgG1 anti-CD40L antibody with high affinity for CD40L (also called CD154), a well-validated biological target with broad therapeutic potential. It was built around safety and engineered to maximize efficacy and half life.
Importantly, AT-1501 targets CD40L (also called CD154), not the CD40 receptor. Blocking CD40L inhibits both CD40 and CD11 costimulatory signaling pathways with the potential for better efficacy. Blocking CD40L also increases polarization of lymphocytes to Tregs, creating a more tolerogenic environment, which provides the potential for better efficacy. CD40L is more selectively expressed than the CD40 receptor, thus the potential for improved safety, as well as pharmacokinetic, pharmacodynamic, and dosing advantages.
Strong Safety and Pharmacokinetic Profile
Novus Therapeutics has completed a Phase 1a/1b single ascending dose trial in healthy volunteers and people with amyotrophic lateral sclerosis (ALS). AT-1501 was well tolerated at all doses tested, demonstrating a good safety profile with low anti-drug antibody responses that were not dose related. AT-1501 also demonstrated linear dose proportionality across the dose ranges and a half-life of up to 26 days. These data suggest the potential for extended dosing intervals and for the development of more convenient administration methods, such as subcutaneous formulations.