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Methods of analyzing virus-derived therapeutics

Summary
Researchers at the National Cancer Institute’s Biopharmaceutical Development Program recently developed massively parallel sequencing methods for virus-derived therapeutics such as viral vaccines and oncolytic immunotherapies, for which the NCI seeks licensees or co-development collaborations.
NIH Reference Number
E-240-2015
Product Type
Keywords
  • massively parallel sequencing, virus-derived therapeutic, viral vaccines, oncolytic immunotherapy,
  • monkey neurovirulence safety testing, MNVT, mutant analysis, restriction enzyme cleavage, MAPREC
  • RNA virus-derived
Collaboration Opportunity
This invention is available for licensing and co-development.
Contact
Description of Technology

Researchers at the National Cancer Institute’s Biopharmaceutical Development Program recently developed massively parallel sequencing methods for virus-derived therapeutics such as viral vaccines and oncolytic immunotherapies. The methods allow for the determination of micro-heterogeneity and quantitation of low frequency sequence variants, which have the possibility of supplanting monkey neurovirulence safety testing (MNVT), mutant analysis by PCR, and restriction enzyme cleavage (MAPREC) methods that are currently used to screen RNA virus-derived therapeutics. The technology is currently in clinical stage.

Potential Commercial Applications
  • Improved methods for detecting mutations in GMP-manufactured virus-derived therapeutics, including viruses, viral template plasmids, or vaccines;
  • The method allows for at least two different virus-derived therapeutics to be assayed simultaneously.
Competitive Advantages
  • Provides a cost- and time-effective means of assaying a virus-derived therapeutic, such as oncolytic viruses, for viral sequence variants, for regulatory approval;
  • RNA virus preparation steps increase the amount of viral RNA obtained;
  • Demonstrated superiority of massively parallel sequencing (“MPS”) over mutant analysis by PCR and restriction enzyme cleavage (“MAPREC”) analysis.
Inventor(s)

Trevor Broadt (NCI), Michael D. Harwich (American International Biotechnology, LLC), William T. Budd (American International Biotechnology, LLC), Gregory A. Myers (American International Biotechnology, LLC)

Development Stage
Patent Status
  • U.S. Patent Filed: U.S. Patent Application Number 15/580,299, Filed 07 Dec 2017
  • Foreign Filed: - Patent Application PCT/US2016/044788, Filed 29 Jul 2016
Therapeutic Area
Updated
Tuesday, December 19, 2017