CFZ533 (or OM11-62-MF) is a a novel anti-CD40 MAB. CFZ533 is fully human, non-agonistic Fc-silent, and has been developed for the treatment of autoimmune diseases and the prevention of organ transplant rejection. This MAB is different to BI 655064, which is an antagonistic anti-CD40 MAB.
Alan Slade an colleagues presented : “Assessment of Safety, Pharmacokinetics and Pharmacodynamics of a Novel AntiCD40 Monoclonal Antibody, CFZ533, in Healthy Volunteers and in Rheumatoid Arthritis Patients”. “The objective of present study was to assess the safety, pharmacokinetics (PK) and pharmacodynamics activity (PD) of CFZ533 in humans”. The double-blinded, placebo controlled study tested 48 healthy volunteers and 12 rheumatoid arthritis patients. Conclusion: “The favorable safety and tolerability profile of CFZ533 coupled with a predictable concentration-CD40 receptor occupancy relationship and suppression of a primary T cell-dependent antibody response supports future clinical trials of CFZ533 in select autoimmune diseases and transplantation”.
The idea behind CFZ533 in rheumatoid arthritis is blocking the CD40-CD154 pathway to prevent T cell-dependent antibody responses. Studies on BI 655064 showed moderate efficacy in rheumatoid arthritis patients and a reduction of circulating inflammatory and bone resorption biomarkers, but this has yet to be shown in CFZ533. Both MABs address CD-40, but both are different. It isn’t clear yet, if the companies involved invest in further development of the two MABs. And it will take years to do the necessary studies.
Slade A, Koo P, He Y, Espie P, Auger-Sarrazin A, Rush JS, Gergely P. Assessment of Safety, Pharmacokinetics and Pharmacodynamics of a Novel Anti-CD40 Monoclonal Antibody, CFZ533, in Healthy Volunteers and in Rheumatoid Arthritis Patients [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/assessment-of-safety-pharmacokinetics-and-pharmacodynamics-of-a-novel-anti-cd40-monoclonal-antibody-cfz533-in-healthy-volunteers-and-in-rheumatoid-arthritis-patients/. Accessed December 2, 2016.