Astellas Pharma and ClearPath Development have partnered to form a portfolio of development companies focused on vaccines targeting infectious diseases. The partnership was established to support Astellas’ goal of building a global vaccine franchise and launched its first company, RSVC, in December 2013. 

Astellas will fund RSVC’s development of a virosome vaccine technology, licensed from Mymetics, for respiratory syncytial virus (RSV) through completion of a phase IIb human proof-of-concept study. Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product.

RSV is a respiratory pathogen which infects patients of all ages. The infection can be especially severe in infants and older adults with chronic pulmonary or cardiovascular disease. Each year the virus infects 64 million people and is responsible for 160,000 deaths worldwide. Currently, there is no vaccine available.

“Together we are harnessing our collective resources to accelerate development of this promising, early stage asset and will replicate this scalable, outcome driven model across future portfolio companies,” said Chuck Finn, Ph.D., chairman, ClearPath Development. 

Mymetics will collaborate with RSVC on the development of the vaccine, with Toon Stegmann, Ph.D., chief scientific officer of Mymetics, remaining engaged on preclinical activities including nonclinical evaluation, formulation development and manufacturing. RSVC’s development team is led by George Siber, M.D.  From 1996 to 2007, Siber was executive vice president and chief scientific officer of Wyeth Vaccines Research, where he oversaw the approval and marketing of six childhood vaccines including Prevnar, Meningitec, Rotashield and FluMist.  

“The financial backing and commercial experience of Astellas, combined with ClearPath’s development experience and our continued program involvement, are unique factors which all work to increase the likelihood of success,” said Ronald Kempers, CEO of Mymetics. “We anticipate RSV will be the first of many vaccine constructs that can be generated from our proprietary second generation virosome platform.” 

For its technology for RSV, Mymetics could receive upfront and post proof-of-concept milestone payments up to $82 million, as well as double-digits royalties. 

The virosome vaccine consists of membrane nanoparticles containing the native key viral surface proteins that are targets of the immune system, but lack the genetic material required to cause infection. In preclinical testing, it generated powerful immune responses and strong protection against RSV. Virosome-based vaccines have a proven track record of safety and efficacy for the prevention of other infections including influenza.