Neovacs and Centurion Pharma will continue the joint development of the investigational vaccine IFNalpha Kinoid for people with systemic lupus erythematosus (SLE) based on the positive results of a Phase 2b clinical study.
The two companies had signed a licensing agreement in July 2017, establishing a partnership to develop the treatment candidate. IFNalpha Kinoid is intended to block all 13 subtypes of the pro-inflammatory molecule IFN-alpha. This molecule activates autoimmune responses and is overproduced in patients with SLE.
To develop the vaccine, Neovacs uses an approach called Kinoid technology, which stimulates the patient’s immune system to produce antibodies against IFN-alpha.
The decision to pursue the collaboration resulted from Centurion’s analysis and validation of findings from a double-blind, global Phase 2b trial (NCT02665364) in 185 patients with moderate to severe SLE. IFNalpha Kinoid was given five times via intramuscular injections at days one, seven, and 28, and at three and six months.
This study showed that IFNalpha Kinoid did not improve clinical response over nine months compared to placebo, as assessed by the BILAG Based Combined Lupus Assessment score. However, the vaccine lessened the use of corticosteroids, raised the number of patients achieving low disease activity, and was well-tolerated.
Patients treated with IFNalpha Kinoid also showed significantly lower levels of IFN-dependent genes at nine months compared to those on placebo.
Through their partnership, Istanbul-based Centurion has acquired an exclusive license to market IFNalpha Kinoid in Turkey.
“The introduction of IFNalpha Kinoid for the treatment of lupus in Turkey is part of our corporate strategy to bring innovative treatment in the field of healthcare into our country, which will reach 90 [million] inhabitants in a few years,” Ersin M. Erfa, Centurion’s CEO, said in a press release.
According to Turkish regulations, Centurion could obtain a marketing authorization for IFNalpha Kinoid once a similar marketing authorization is obtained in another country.
As part of the agreement, Centurion will pay 6 million euros to Neovacs. A first payment was made when the companies signed the original agreement. Further payments are planned according to clinical and regulatory milestones. Neovacs will also receive royalties for IFNalpha Kinoid’s net sales in Turkey.
France-based Neovacs is preparing to seek orphan drug designation for IFNalpha Kinoid in South Korea. If granted, this designation would accelerate submission for registration.
Neovacs is also working on the protocol of a Phase 3 trial, as well on strategies for the registration of IFNalpha Kinoid. In December 2016, the U.S. Food and Drug Administration granted Fast Track designation to the therapy. Besides SLE, IFNalpha Kinoid is also being developed for dermatomyositis and type 1 diabetes.