ROCKVILLE, Md. ROCKVILLE, Maryland – Vigene Biosciences, Inc. (Vigene), a leading biotechnology company for clinical and research-grade viral vector production and development, announces a partnership with Mila’s Miracle Foundation (MMF) to manufacture recombinant adeno-associated virus (rAAV) needed to advance clinical trials for CLN7 Batten Disease.
Batten Disease (also referred to as neuronal ceroid lipofuscinoses (NCL)) is a group of recessively inherited rare neurodegenerative diseases of childhood with a worldwide incidence 1 to 8 in 100,000 live births. They share common clinical features including progressive visual failure, epileptic seizures, and progressive psychomotor decline. There is no known cure, no FDA-approved therapies, with only limited therapeutic treatments that manage disease symptoms; the disease is inevitably fatal. AAV-based gene therapy has shown great promise.
Vigene has developed technologies to manufacture cGMP grade rAAV vectors in large scale with a fast turn-around time. Today, MMF and Vigene announce they have entered into a definitive agreement for Vigene to manufacture the rAAV needed for MMF to proceed with clinical trials using rAAV-CLN7 as the therapeutic agent for Batten Disease.
“We have interviewed dozens of CMOs in the world to identify the best manufacturing partner for the Foundation. Vigene stood out as the ideal partner given their technology to manufacture within the time frame and within our budget. In addition, Vigene’s capability to manufacture animal study material in a speedy fashion is perfectly in line with the Foundation’s mission to bring a therapy to clinical trials in the shortest period of time possible”, said Julia Vitarello, The Founder and President of MMF.
“We are excited about the partnership with Mila Miracle Foundation to manufacture and produce the clinical rAAV-CLN7 vectors to treat CLN7 Batten Disease patients”, continued Dr. Jeffrey Hung, the General Manager of GMP Production at Vigene. “We are also humbled by the fact that the suffering children are waiting for the clinical material to treat the disorder. Vigene’s mission is to make gene therapy affordable. This partnership speaks volume about innovation and hard work we have put in to gene therapy manufacturing”, concluded Dr. Hung.
Jeffrey Hung, Ph.D.
Chief Commercial Officer