ReciBioPharm, the advanced and emerging therapies business unit of Recipharm, has announced a collaboration agreement with GeneVentiv Therapeutics, a pre-clinical gene therapy company, to advance development of an Adeno-Associated Virus (AAV)-based universal gene therapy for haemophilia, and the first to treat haemophilia patients with inhibitors.
On average 30 percent of people with haemophilia A and about 5 percent of people with haemophilia B will develop an inhibitor (an antibody) to the treatment they receive to manage a bleeding episode.
The ReciBioPharm and GeneVentiv partnership will help address the currently unmet need for AAV-based gene therapies for haemophilia patients with inhibitors.
GeneVentiv’s GENV-HEM (AAV8.FVa) is the first, single infusion, universal AAV-based gene therapy for all types of haemophilia and has demonstrated therapeutic efficacy and safety in preclinical studies.
This collaboration will see ReciBioPharm accelerate the development of this technology using its cutting-edge AAV manufacturing platform.
AAV therapy development is complex: the manufacturing process requires cost efficiencies, flexibility and speed to be built into every stage of the process to ensure crucial milestones are met.
ReciBioPharm will utilise its AAV platform at its Watertown facility in Massachusetts, to advance GeneVentiv’s therapy from early stage pre-clinical to Phase I/II clinical studies.
Xiaojun Liu, Director of AAV process development at ReciBioPharm said: “We are delighted to be working with GeneVentiv, an ambitious and innovative biotech who wanted to leverage not just our equipment and space, but our extensive knowledge and expertise too.”
Damon Race, CEO of GeneVentiv Therapeutics said: “Gene therapies pose unique development and manufacturing challenges, so it was essential we chose the right partner to collaborate with, to minimise manufacturing risks and ensure we meet our key development milestones.”
“ReciBioPharm quickly demonstrated that their team is the perfect development and manufacturing partner for our asset, enabling us to access their extensive experience and impressive capabilities. Our collaboration with them provides us with GLP and GMP product to meet both our IND and Phase I/II milestones.”
