By Alex Keown
WAVE Life Sciences has officially opened a new state-of-the art manufacturing facility to support advancement of the company’s stereopure nucleic acid platform.
The new 90,000 square-foot facility, located in nearby Lexington, Mass., is expected to house up to 200 employees, although the company noted that that number is a long-term goal. Wave began using the new facility in July. The majority of the space is dedicated to manufacturing and laboratories. Wave Life said the new space is also intended for non-manufacturing employees and was designed to support the company’s continued expansion.
Having the new manufacturing space is part of the company’s long-term strategy of platform sustainability and independence. The Lexington site has been designed to support Wave Life’s advancing clinical pipeline of drug candidates. The company anticipates to have six programs in the clinic by the end of 2018. In August, the company announced it transitioned into a clinical stage company, with the beginning of two phase Ib/IIa trials in Huntington’s disease, dubbed PRECISION-HD1 and PRECISION-HD2. Each trial will target a single nucleotide polymorphism (SNP), that marks a separate and distinct location on the mutant huntingtin (HTT) gene transcript, the company said.
WVE-210201, Wave’s lead program for Duchenne muscular dystrophy is expected to enter the clinic in the second half of 2017. Another program the company is expanding is a C9orf72 targeting program, which is aimed at treating the neurodegenerative disorders of ALS (amyotrophic lateral sclerosis) and FTD (frontotemporal degeneration). In August, Wave said it is targeting pathological C9orf72 mutations resulting from repeat expansions in the gene. Wave anticipates clinical trial initiation of ALS and FTD programs in late 2018.
“The expansion of our manufacturing capabilities is a critical milestone in our evolution as a clinical-stage company and a further commitment to our pledge of providing much needed therapies to patients living with serious, genetically-defined diseases,” Wave Life’s Chief Executive Officer Paul Bolno said in a statement. “Our facility in Lexington bolsters our growth and investment in Massachusetts, where we can best access the talent of the Commonwealth’s world-class life sciences community.”
The three-story Lexington facility is designed to be good manufacturing practice (GMP) certified and to have oligonucleotide synthesis capacity ranging from high throughput to large scale production. The new lab space is designed to meet the synthesis demands of Wave’s growing portfolio, while also increasing control and visibility of its product supply chain, the company said.
As of June 30, Wave reported cash and cash equivalents of $197.4 million. Shares of Wave Life Sciences are trading at $21.85 as of 9:54 a.m.