Data from a Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA) was recently released by drug developer NEOVACS, a leader in the development of an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. The results from the trial revealed a good safety profile and antibody production, but did not reach the efficacy endpoints.
“We are disappointed that our TNF-Kinoid Phase IIb study did not have a positive outcome, given the potential benefits that this new approach would have brought to patients suffering from RA.” said Miguel Sieler, Neovacs CEO, in a press release.
Sieler said that the company will analyze the data further, but will now shift the focus of their clinical development for IFNα-Kinoid to lupus, a disease that affects over 6 million people in the world and which currently has no viable therapy.
The Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA) was completed in 2014 by Neovacs. This trial consisted of a randomized, double-blind, placebo-controlled, multi center study that enrolled 140 patients, with the co-primary endpoints based on the DAS28-CRP and ACR 20 scores, respectively; a Disease Activity Score of 28 based on C-reactive protein; and a percentage showing how much a person’s rheumatoid arthritis (RA) had improved — a score normally used in clinical trials for RA. The study showed that the TNF-Kinoid was safe and well tolerated by the patients. Additionally, every patient besides one showed a notable immune response with the production of antibodies against TNF. On the other hand, the patients did not have neutralizing antibodies, which may explain the absence of clinical response. These data will be analyzed further by Neovacs establish the lack of significant clinical response.
“The findings of the TNF-Kinoid study in RA and our continued work with this program have allowed us to make significant progress on our understanding of active immunotherapies for the treatment of auto-immune diseases. The clinical results of this study do not preclude further development of the Kinoid platform, in particular IFNα-Kinoid in lupus. Neovacs’ program in lupus is highly promising from a scientific perspective, based on the existing clinical and preclinical findings which show strong immune response with neutralizing antibodies, as well as an improvement of lupus related biomarkers,” said Professor Jacques Banchereau, Ph.D, chairman of Neovacs’ scientific advisory board.
A Phase IIb clinical trial on IFNα-Kinoid in Lupus will start in Europe, Latin America and Asia in 2015, and a Phase IIa study will start in the U.S. in early 2016, depending on the date of regulatory approvals. Last June, Neovacs released results showing that polyclonal antibodies produced by lupus patients after being immunized with IFNα-Kinoid bounded all excess IFNα subtypes.
Pierre Vandepapeliere, M.D., Ph.D., Neovacs Chief Medical Officer, said that the Neovacs’ therapy is different from any other since they developed specific neutralizing antibodies for 13 subtypes of IFNα highly expressed in lupus. He added that the Kinoid is the first therapy to have this total and specific neutralization and may be a promising and important therapy for lupus.