AiCuris and Hybridize Therapeutics enter worldwide license agreement of up to €100M

AiCuris Anti-infective Cures AG (AiCuris), a company focused to the discovery and development of drugs against infectious diseases, and Hybridize Therapeutics (Hybridize), focused on the development of RNA-based therapies for patients with acute and chronic kidney diseases, have announced that they have entered into a worldwide licensing agreement for Hybridize’s BK virus (BKV) program. The licensed program is based on a novel RNA-based therapeutic approach developed by Hybridize.

According to the agreement, AiCuris will gain exclusive rights to develop and commercialize Hybridize’s BKV program, with focus on the treatment of BK virus-mediated nephropathy in renal transplant patients. Hybridize will receive an upfront payment and further milestone payments of up to €100 million in total based on successful achievement of development, regulatory and commercialization goals. In addition, Hybridize will receive tiered royalties on net sales. Hybridize and AiCuris will collaborate in the further development of the BKV-targeting therapy until the start of clinical studies, which is expected within two years, said AiCuris in its press release.

“We are excited to gain the rights to this exciting RNA-based antisense approach against BKV infections, further strengthening our anti-infective pipeline and building on our strong track record in the field of infectious diseases in transplant patients,” said Dr. Holger Zimmermann, CEO of AiCuris. “With PREVYMIS approved and licensed to MSD for use in bone marrow transplants for the prevention of cytomegalovirus (CMV) infections, and Pritelivir in phase 3 development for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients, this BKV-targeting RNA-based therapeutic approach represents our third project in the field of transplantation medicine.”

Dr. Zimmermann further  explained: “BKV infection is one of the most common viral infections affecting kidney transplant patients. Yet, there are no treatments approved to fight them. BK virus is difficult to treat as it is not addressable using conventional approaches such as classical enzyme inhibitors. We believe that antisense oligonucleotides are a promising novel approach to block BKV replication. If shown to be safe and effective, this approach could be a true game changer in transplantation medicine with the potential to prevent kidney transplant patients from developing graft rejection and organ loss due to BKV.”

Hybridize’s RNA-based program is designed to target a protein critical for viral replication by modulating the splicing process of the protein-encoding mRNA, preventing its synthesis and thus replication of the virus. The Hybridize program is believed to be the only direct acting antiviral therapeutic in development, working intracellularly and therefore protecting the kidney cells from within. In several scientific papers, antisense oligonucleotides were shown to be effective inhibitors of hepatitis B virus replication in vitro, AiCuris said.

Eline van Beest, CEO of Hybridize Therapeutics said: “We are convinced that AiCuris’ excellence in the development of anti-infective therapies and its deep and proven experience in bringing drug candidates through clinical development and onto the market makes them the perfect partner to advance our RNA-based BKV program to the clinic.“

Eline van Beest also commented that the upfront and milestone payments will considerably increase fire power to Hybridize and allow it to expand its proprietary pipeline with a number of as yet undisclosed RNA therapies.