Astellas Pharma Inc. (Astellas) and ClearPath Development Company (ClearPath) have announced a strategic partnership 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, RSV Corporation (RSVC), in December 2013.
Astellas will fund RSVC’s development of a virosome vaccine technology, licensed from Mymetics Corporation (Mymetics - OTC BB: MYMX), for respiratory syncytial virus (RSV) through completion of a Phase 2b human proof-of-concept study. Based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product.
“This partnership highlights our commitment to build a global vaccine business and represents a highly efficient model for bringing innovative vaccines to market. It is also a unique opportunity for Astellas to utilize external cutting edge science and technology to enhance our ability to generate innovative drugs, as part of the “Reshaping Research Framework” program announced in May, 2013,” said Kenji Yasukawa, Senior Vice President and Chief Strategy Officer, Astellas.
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 for this virus.
“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, PhD, Chairman, ClearPath Development Company.
Mymetics will collaborate with RSVC on the development of the vaccine, with Toon Stegmann PhD, CSO of Mymetics, remaining engaged on pre-clinical activities including nonclinical evaluation, formulation development, and manufacturing. RSVC’s development team is led by George Siber, MD, a recognized vaccine expert with more than 35 years experience.
From 1996 to 2007, Dr. 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 expertise and our continued program involvement are unique factors which all work to increase the likelihood of success,” said Ronald Kempers, CEO, Mymetics. “We anticipate RSV will be the first of many vaccine constructs that can be generated from our proprietary 2nd 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 and other payments.
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 pre-clinical 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.