[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56026-56027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice; Licensing and Collaboration Opportunity

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is directed to potential peptidyl 
therapeutics that counteract with amyloid forming IAPP and amyloid-
[beta] in treatments of diabetes and Alzheimer's disease and serve as 
blood-based biomarkers for Alzheimer's disease. This technology was 
discovered and is being developed by the National Institute on Aging 
(NIA). The NIA is currently seeking a licensee and/or collaborator to 
further develop this technology.

FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing 
and collaboration opportunity should be directed to: Zarpheen Jinnah, 
Technology Transfer Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702 Telephone: (240) 276-5530; 
Facsimile: (240) 276-5504 Email: [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to this invention.

SUPPLEMENTARY INFORMATION: The following patent application is 
available for licensing and/or collaboration under a Cooperative 
Research and Development Agreement (CRADA):
    U.S. Provisional Application No. 63/417,582.
    Achieving expeditious commercialization of federally funded 
research and development is consistent with the goals of the Bayh-Dole 
Act, codified as 35 U.S.C. 200-212.
    Background and Description of Technology: Over 34 million Americans 
are living with diabetes and an estimated 6.5 million Americans are 
living with Alzheimer's disease (AD). A

[[Page 56027]]

hallmark feature of type 2 diabetes mellitus (T2DM) is the accumulation 
of islet amyloid polypeptide fibrils in pancreatic islets. Such 
accumulations form amyloid plaques, referred to as islet amyloidosis. 
Amyloidosis due to aggregation of amyloid-[beta] is key pathogenic 
event in AD, whereas aggregation of mature islet amyloid polypeptide 
(IAPP37) in human islet leads to [beta]-cell dysfunction. 
Researchers at NIA used a bioinformatic approach to identify two novel 
islet amyloid polypeptide isoforms: IAPP[beta], encoding an elongated 
propeptide and non-aggregating IAPP[gamma], which is processed to 
mature IAPP25 instead of IAPP37. They developed a 
quantitative selective reaction monitoring (SRM) proteomic assay to 
measure the isoform peptide levels in human clinical plasma and CSF 
from individuals with early AD and found that their levels were 
significantly reduced. Further, mature IAPP25 derived from 
IAPP[gamma] isoform inhibits fibrillation of IAPP and amyloid-[beta] 
efficiently in vitro.
    Potential Commercial Applications: The novel IAPP[beta] and 
IAPP[gamma] isoforms are potential peptidyl therapeutics to counteract 
with amyloid forming IAPP and amyloid-[beta] in treatments of diabetes 
and Alzheimer's disease and serve as blood-based biomarkers for 
Alzheimer's disease.
    Competitive Advantages:
     Peptide based anti-amyloid medicine.
     Potential market applications for neurodegenerative 
diseases.
    Development Stage: Pre-clinical (in vivo validation).
    Publications: Liu, Q.-R., et al. Novel Hominid-Specific IAPP 
Isoforms: Potential Biomarkers of Early Alzheimer's Disease and 
Inhibitors of Amyloid Formation. (PMID 36671553) at https://pubmed.ncbi.nlm.nih.gov/36671553/.
    Meng, Lanxia, et al. Islet amyloid polypeptide triggers [alpha]-
synuclein pathology in Parkinson's disease. (PMID 37150314)

    Dated: August 11, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-17673 Filed 8-16-23; 8:45 am]
BILLING CODE 4140-01-P