Wuppertal-based AiCuris (Anti-infective Cures) AG will pay up to € 100 m to Dutch company Hybridize Therapeutics BV for the development of antisense RNA therapeutics. These will be used to prevent severe disease caused by BK viruses in immunocompromised patients.

AiCuris, the infectious disease specialist, is expanding its pipeline through the licensing agreement with Hybridize Therapeutics, a spin-off of Leiden University Medical Center (LUMC). The Dutch company's expertise in RNA therapeutics, particularly antisense oligo (ASO) technology, will be used to develop a drug to prevent severe BK virus (BKV) infections in immunocompromised patients, for example after kidney transplants. BKV-associated nephropathy (BKN) is a major cause of allograft dysfunction and rejection in transplant recipients. According to recent studies, one third of organ recipients develop BK viraemia shortly after transplantation, and almost 8% have BKV-associated nephropathy.

The licensing of Hybridize's RNA-based BKV program gives AiCuris exclusive rights to further develop and commercialise this approach, with a treatment focus on BK virus-mediated nephropathy in kidney transplant patients. Hybridize will receive an upfront payment and further milestone payments of up to € 100 m in total upon market approval. In addition, Hybridize will receive tiered royalties on net sales.

Both companies expect to begin clinical trials within two years. The new program is AiCuris' third project in the field of transplant medicine. "The BK virus is difficult to treat because it cannot be addressed with conventional approaches such as classical enzyme inhibitors," said Dr Holger Zimmermann, CEO of AiCuris AG. "We believe that antisense oligonucleotides are a promising new approach to block BKV replication." Zimmermann further explained that AiCuris had set up a screening process to specifically look for suitable candidates and technology platforms to expand its own pipeline. In the process, Hybridize landed at the top of the priority list, both in terms of indication and technological approach.