Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, and Wave Life Sciences, a clinical-stage genetic medicines company developing life-changing treatments for people battling devastating diseases, have entered into an agreement for the development and commercialization of companion diagnostics for Wave’s investigational allele-selective therapeutic programs targeting Huntington’s disease (HD).
HD is a devastating disorder caused by an expansion of CAG repeats in the HTT gene that results in the progressive breakdown of nerve cells in the brain. It deteriorates a person’s physical and mental abilities, usually during their prime working years, is ultimately fatal and has no cure.
The companion diagnostics that Asuragen will develop build on the experience gained by Wave using a single-nucleotide polymorphism (SNP) phasing methodology in Wave’s current clinical trials in HD and a previous observational study. This collaboration aims to use Asuragen’s market-leading repetitive sequence diagnostic expertise to provide scalable SNP phasing to support potential global Phase 3 development programs and future commercialization at a global level.
“Our partnership with Asuragen for companion diagnostic development was a natural fit in light of their deep knowledge and expertise with challenging molecular targets, diagnostic regulatory experience and their growing presence in the neurogenetics testing market,” said Jaya Goyal, Ph.D., Vice President of Bioanalytics, Pharmacology, and Biomarker Development at Wave Life Sciences.
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Asuragen’s AmplideX® PCR technology has revolutionized the analysis of repeat expansions in multiple neurological disorders. Asuragen will leverage this technology to develop companion diagnostic tests that size and phase HTT CAG repeats with two different SNPs targeted by Wave’s WVE-120101 and WVE-120102 investigational therapeutic programs. These SNPs are represented alone or together in up to 70% of the HD population. The intended use of the tests is to aid clinicians in selecting HD patients who would be appropriate for one of Wave’s HD compounds by identifying the SNPs that are uniquely linked to the CAG-expanded allele.
“We’re pleased to be a part of this new category of potential therapies and to have a positive impact on such a devastating disease. Developing a companion diagnostic for Wave’s novel allele-selective silencing program in HD is a great example of how our products will continue to advance personalized medicine,” said Matthew McManus, M.D., Ph.D. president and CEO of Asuragen.
Wave is currently conducting two Phase 1b/2a clinical trials, PRECISION-HD1 and PRECISION-HD2, for patients with HD. The trials are evaluating WVE-120101 and WVE-120102, which are stereopure oligonucleotides designed to lower the mutant HTT mRNA transcript by targeting one of two SNPs while leaving the wild-type transcript relatively intact. Wave expects to report topline data from the PRECISION-HD2 and PRECISION-HD1 trials by end of 2019 and early 2020, respectively.
Source: Business Wire
