[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25284-25285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and

[[Page 25285]]

development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Chris Kornak at 240-627-3705 or 
<a href="/cdn-cgi/l/email-protection#e1a289938892cfaa8e938f808aa18f8889cf868e97"><span class="__cf_email__" data-cfemail="7a391208130954311508141b113a141312541d150c">[email protected]</span></a>. Licensing information may be obtained by 
communicating with the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Replication-Competent Adenovirus Type-4 HIV Env Vaccines and Their Use

    Description of Technology: National Institute of Allergy and 
Infectious Diseases (NIAID), International AIDS Vaccine Initiative 
(IAVI), Emergent, and Scripps have developed two recombinant adenovirus 
type 4 (Ad4) vector-based vaccine candidates. These replicating Ad4 
vector-based candidates have shown improved activity against tier 2 
HIV-1 isolates in experimental animals. Tier 2 isolates are among the 
most prevalent in infected populations. The two candidates, Ad4-
Env150KN and Ad4-Env145NFL, incorporate novel design features based on 
Ad4-EnvC150 (1086c). Specifically, the truncation of the cytoplasmic 
tail of Env increases cell surface expression and has resulted in 
improved antigenicity from both candidates.
    Additionally, the upper respiratory tract administration offers a 
way to bypass pre-existing Ad4 immunity in most people. Furthermore, 
unlike non-replicating vectors, these vaccines may evoke a durable 
immune response.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

    <bullet> Prophylaxis against HIV-1.

Competitive Advantages

    <bullet> Replicating vector may invoke durable immunity against 
HIV-1.
    <bullet> Potential for prophylactic use in high-risk populations.
    <bullet> Upper-respiratory (intranasal) administration will bypass 
pre-existing Ad4 immunity in most people.

Development Stage

    <bullet> Phase 1 Clinical Trial (NCT03878121).
    Inventors: Mark Connors (NIAID), Jeff Alexander (Emergent), Lo Vang 
(Emergent), Richard Wyatt (Scripps and IAVI), and Javier Guenaga 
(IAVI).
    Publications: Alexander J., Mendy J., Vang L., Avanzini J.B., 
Garduno F., et al. (2013) Pre-Clinical Development of a Recombinant, 
Replication-Competent Adenovirus Serotype 4 Vector Vaccine Expressing 
HIV-1 Envelope 1086 Clade C. PLOS ONE 8(12): e82380. https://doi.org/10.1371/journal.pone.0082380.
    Intellectual Property: HHS Reference No. E-105-2020-0-PCT-01--PCT 
Application No. PCT/US21/45389 filed on 10 August 2021.
    Licensing Contact: To license this technology, please contact Chris 
Kornak at 240-627-3705 or <a href="/cdn-cgi/l/email-protection#63200b110a104d280c110d0208230d0a0b4d040c15"><span class="__cf_email__" data-cfemail="eba883998298c5a08499858a80ab858283c58c849d">[email protected]</span></a>, and reference E-105-
2020.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize this technology. In particular, 
NIAID would be very interested in a partnership with an entity that has 
a complementary HIV vaccine technology. For collaboration 
opportunities, please contact Chris Kornak at 240-627-3705 or 
<a href="/cdn-cgi/l/email-protection#2b684359425805604459454a406b454243054c445d"><span class="__cf_email__" data-cfemail="0e4d667c677d2045617c606f654e60676620696178">[email protected]</span></a>.

    Dated: April 25, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-09158 Filed 4-27-22; 8:45 am]
BILLING CODE 4140-01-P


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