Regulatory Focus™ > News Articles > NIH Looks to License out Technologies for Potential HIV Vaccine, Autism Screening Technology

NIH Looks to License out Technologies for Potential HIV Vaccine, Autism Screening Technology

Posted 28 May 2013 | By Alexander Gaffney, RAC

The National Institutes of Health (NIH) and the National Center for Advancing Translational Sciences (NCATS), a recently formed center within the National Institutes of Health (NIH) focused on bringing new products to market and solving regulatory challenges, have announced an opportunity for industry to license five new products, including an assay for a common cause of autism, an inhibitor of potential use for a HIV vaccine, a fusion protein of potential use for an HIV vaccine, a research reagent to develop CH2-based therapeutics, and a method of producing stem cell-like memory T-cells for use in immunotherapy.


The publication of the five technologies is meant to spur private partners to come in and license the technologies from NIH and NCATS. A similar notice published in February 2013 identified two potential therapies, one for Gaucher's disease and another for heart failure and fibrosis, with the stipulation that any partner looking to license the experimental products would need to be able to show it could bring the products to market. In other words, the partners will need to have the regulatory affairs know-how to get a product through FDA.

"Collaborators should have experience in the pre-clinical development of small molecules and a track record of successful submission of IND applications to the FDA for rare and neglected diseases," NCATS explained in its notice.

New Developments

No such stipulations are present in NIH's 28 May 2013 announcement regarding five novel technologies, though the intent is similar: find interested private-sector entities that are interested in researching, evaluating, and commercializing technologies now under development by NCATS and other NIH agencies. The commercialization aspect might, in theory, involve similar regulatory considerations.

Those technologies are as follows:

  • A fluorescence-based assay meant to quantify the protein product indicative of the presence of the Fragile X Mental Retardation-I (FMRI) gene defect in a biological sample. Fragile X Syndrome-the most common genetic cause of autism-currently has no approved treatments, and NCATS explained that its assay "can be used as a high throughput screen to identify and evaluate candidate drugs." The product is still in a prototype stage of development. (NCATS)
  • A novel HIV-1 entry inhibitor that is "highly soluble and stable with significantly higher neutralizing activity and lower non-specific binding to human blood cell lines." NCATS said the inhibitor is "highly promising," and could be used as an HIV therapeutic, prophylactic, as a means of detecting HIV, and as a research reagent. The product remains in the early stages of development. (NIH)
  • A novel protein product that could potentially be used as a vaccine for HIV or as a research reagent. (NIH)
  • A novel human antibody that could be used to develop CH2-based novel therapeutics such as nanoantibodies. (NIH)
  • A method for producing stem cell-like memory T-cells for use in T Cell-based immunotherapies. NCATS says it has developed methods to develop "high numbers of these cells" for use in immunotherapies, potentially generating further cell subsets. NIH said this could be used to treat patients with cancer or other chronic infectious diseases. (NIH)

Companies that wish to work with NIH on these technologies can contact it here.

Editor's Note: A previous version of this article noted that NCATS was associated with all five notices. It is only associated with the Fragile X Mental Retardation (FMRI) gene defect notice. We regret the error.


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