Neovacs, BioSense Ink Accord to Develop Lupus Vaccine in China

Neovacs and BioSense Global will jointly develop an interferon alpha (IFNα) vaccine to treat lupus and dermatomyositis in China.

News of the commercial licensing agreement, worth up to €65 million, comes just days after Chinese authorities issued a patent for Neovacs’ IFNα vaccine (IFNα Kinoid) for diseases characterized by over-expression of the cytokine IFNα.

Neovacs’ technology targets diseases associated with an overproduction of endogenous cytokines – small mediators released by specific immune cell subsets that play key roles in moderating both innate and adaptive immune responses.

Too little or too much cytokine production, as well as abnormal immune-cell response to the presence of cytokines, can lead to immune-mediated diseases, like lupus.

Injecting IFNα Kinoid in muscle induces an immune response. It also stimulates the production of polyclonal antibodies that block the overproduction of the cytokine IFNα, as well as the effects of that overproduction.

If Paris-based Neovacs successfully completes its ongoing Phase 2b trial for IFNα Kinoid in lupus (NCT02665364), BioSense, which has headquarters in both New Jersey and China, will receive commercial rights for IFNα Kinoid in lupus and dermatomyositis for China (including Macao and Hong Kong) as well as Taiwan and Singapore.

After completion of this trial, BioSense will fund a Phase 3 clinical trial to seek regulatory approval in those markets. Neovacs will retain rights for other regions of the world, except for South Korea.

“This transaction, as well as the commercial licensing agreement signed last year for the South Korean market, is indicative of the significant worldwide commercial potential of IFN Kinoid,” Miguel Sieler, CEO of Neovacs, said in a press release. “While we have been able to retain rights for the rest of the world — especially the valuable U.S. and European markets, for which we have other discussions ongoing — we recognize that China is the world’s second-largest pharmaceutical market, where close to one million patients are suffering from lupus.”

Added BioSense CEO Andy Li, PhD: “We believe that IFNα Kinoid has significant medical value and commercial potential in Asia and China in particular, and we are very excited about the opportunity to bring this innovative product to meet the significant unmet medical needs in China and other selected markets.”