90298 Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 

Dated: November 6, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26682 Filed 11–14–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing or 

Collaboration: Novel Kinase Inhibitory 

Aplithianines 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute 

(NCI), an institute of the National 

Institutes of Health (NIH), Department 

of Health and Human Services (HHS), is 

giving notice of the licensing and/or 

collaboration opportunities for the 

inventions listed below, which are 

owned by an agency of the U.S. 

Government and are available for 

licensing and/or collaboration to 

achieve expeditious commercialization 

of results of federally-funded research 

and development. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to these licensing or 

collaboration opportunities should be 

directed to: Taryn Dick, Ph.D., M.B.A., 

Technology Transfer Manager, NCI, 

Technology Transfer Center, Email: 

taryn.dick@nih.gov or Phone: 301–631– 

3007. 

SUPPLEMENTARY INFORMATION: 

Researchers at the NCI seek licensing 

and/or co-development research 

collaborations for a class of novel 

aplithianine-derived small molecule 

analogs that compete with ATP for 

binding on a range of clinically relevant 

kinases. In 2022, the NCI Molecular 

Targets Program (MTP) completed a 

screen of approximately 150,000 prefractionated natural products from the 

NCI Program for Natural Product 

Discovery (NPNPD). From this screen, a 

class of active compounds, named 

Aplithianines A & B (isolated from the 

marine organism Aplidium sp.), showed 

broad potential applicability to 

numerous kinases of importance, 

including but not limited to: 

• Oncogenic gene fusion DNAJB1– 

PRKACA (PKADJ): 

Æ Implicated in an ultra-rare 

adolescent liver cancer. 

• Wild type protein kinase A (PKA): 

Æ Implicated in Cushing’s Disease. 

• Protein kinase G (PKG): 

Æ Potential treatment of malaria. 

• Ccdc2-like kinases (CLK) 1 and 2: 

Æ Implicated in gastric cancer. 

• DYRK family of kinases: 

Æ Implicated in gastric or colon 

cancer as well as infections caused by 

a protozoa or parasites. 

This technology describes the 

Original Family of compounds filed. 

Subsequent to this filing, two additional 

cohorts of related, but patentably 

distinct cohorts of compounds, have 

been filed. Both the Second and the 

Third Cohorts comprise the same 

chemical scaffold of the broadest 

generic formula of this Original Family 

but represent patentably distinct 

subgenus formulas. 

BILLING CODE 4140–01–P 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 90299 

BILLING CODE 4140–01–C The specificity of several of the 

compounds have been examined in 

kinase panels to demonstrate that while 

applicable to a range of kinases, they are 


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Parent natural products 

isolated from the marine 

organism Aplidium sp. 

NIH Reference Number: 

E-044-2022 patent family 

("Original Family"): 

The claims are directed to 

compositions of matter 

encompassing this broad 

Markush structure. 

NIH Reference Number: 

E-202-2023 patent family 

("Second Cohort") 

The claims are directed to 

compositions of matter 

encompassing these 

broad Markush 

structures. 

NIH Reference Number: 

E-162-2024 

Patent family 

("'Third Cohort") 

The claims are directed to 

compositions of matter 

encompassing this broad 

Markush structures. 

Structural Reoresentatives: 

Aplithianines A 

(1) 

Aplithianines B 

(I) 

XrNH 

,::7" N 

~,JlR, 

(Ia) 

(It) 
90300 Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 

not promiscuous kinase inhibitors. The 

subject kinase inhibitors have broad 

potential commercial applicability’s for 

cancer, immune suppression, 

preventing organ rejection, treating 

diabetic neuropathic pain, malaria, or 

protozoa infection. To date, there are no 

approved therapeutics targeting 

DNAJB1–PRKCA, an oncogenic gene 

fusion, which is ubiquitously and 

exclusively detected in the tumors of 

patients with ultra-rare fibrolamellar 

hepatocellular carcinoma FLHCC. 

This Notice is in accordance with 35 

U.S.C. 209 and 37 CFR part 404. 

NIH Reference Number: E–044–2022. 

Related Technologies: E–202–2023 

and E–162–2024. 

Product Type: Therapeutic. 

Therapeutic Area(s): Oncology, 

Infectious Disease, Rare/Neglected 

Diseases. 

Potential Commercial Applications: 

• Gastric cancer.

• Ultra-rare adolescent liver cancer.

• Solid cancers susceptible to kinase

inhibitors. 

• Cushing’s Disease.

• Transplantation.

• Diabetic neuropathic pain.

• Malaria.

• Protozoa infection.

Competitive Advantages:

• Applicability to numerous

clinically relevant kinases, including: 

Æ Oncogenic gene fusion DNAJB1– 

PRKACA (PKADJ). 

Æ Wild type protein kinase A (PKA). 

Æ Protein kinase G (PKG). 

Æ Ccdc2-like kinases (CLK) 1 and 2. 

Æ DYRK family of kinases. 

• Applicable to a range of kinases, but

are not promiscuous kinase inhibitors. 

• Broad potential commercial

applicability for several blockbuster 

indications including: 

Æ cancer, immune suppression, 

transplantation, diabetic neuropathic 

pain, malaria, and protozoa infection. 

• No approved therapeutics targeting

DNAJB1–PRKCA. 

Publications: 

• O’Keefe BR, et al. Biochemical

Discovery, Intracellular Evaluation, and 

Crystallographic Characterization of 

Synthetic and Natural Product 

Adenosine 3′,5′-Cyclic MonophosphateDependent Protein Kinase A (PKA) 

Inhibitors. PMID: 37082750, https://

pubmed.ncbi.nlm.nih.gov/37082750/. 

• O’Keefe BR, et al. Discovery and

Synthesis of a Naturally Derived Protein 

Kinase Inhibitor that Selectively Inhibits 

Distinct Classes of Serine/Threonine 

Kinases. PMID: 37843072, https://

pubmed.ncbi.nlm.nih.gov/37843072/. 

Patent Status: 

• E–044–2022: PCT/US2023/070304.

• E–202–2023: PCT/US2024/038376.

• E–162–2024: 63/672,577.

Development Stage: Pre-clinical (in

vivo validation). 

Dated: November 12, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–26663 Filed 11–14–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Complementary and Integrative Health 

Special Emphasis Panel; NCCIH Conference 

Grant (R13 Clinical Trial Not Allowed). 

Date: December 10, 2024 

Time: 2:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Center for 

Complementary and Integrative, Democracy 

II, 6707 Democracy Blvd., Bethesda, MD 

20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Michael E. Authement, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review, Division of Extramural 

Activities, 6707 Democracy Boulevard, 

Bethesda, MD 20817, michael.authement@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: November 8, 2024. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–26562 Filed 11–14–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing or 

Collaboration: Improved Methods for 

Cryopreservation of Cells, Tissues, 

and Organs 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Eye Institute 

(NEI), an institute of the National 

Institutes of Health (NIH), Department 

of Health and Human Services (HHS), is 

giving notice of licensing and/or 

collaboration opportunities for the 

inventions listed below, which are 

owned by an agency of the U.S. 

Government and are available for 

licensing and/or collaboration to 

achieve expeditious commercialization 

of results of federally-funded research 

and development. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to these licensing and/ 

or collaboration opportunities should be 

directed to: Hiba Alsaffar, Ph.D., 

Technology Transfer Manager, NCI, 

Technology Transfer Center, Email: 

hiba.alsaffar@nih.gov or Phone: 240– 

276–7489. 

SUPPLEMENTARY INFORMATION: 

Researchers at the NEI seek licensing 

and/or co-development research 

collaborations for improved methods of 

cryopreservation of cells, tissues, and 

organs via FOXO1 activation. The 

cornea is a critical part of the eye that 

helps prevent debris from entering and 

refracts light for proper vision. Corneal 

disorders such as keratoconus, Fuchs 

dystrophy, and infectious keratitis 

require corneal transplantation to 

restore vision. Approximately 185,000 

corneal transplants are performed 

annually worldwide to treat corneal 

disorders. Corneas for those transplants 

are supplied by donor eyes that are 

stored at eye banks in select countries. 

Currently, Optisol-GSTM is the corneal 

preservation solution that is most 

widely used to store donated corneas at 

eye banks. Per NEI guidelines, corneas 

preserved in Optisol-GSTM have a 12- 

day shelf life. With the high demand for 

corneal transplantations worldwide, a 

12-day shelf life cannot meet the

requirement for long term cryogenic

storage of corneas at large eye banks.

Scientists at the NEI have developed

improved methods for cryopreservation

of cells, tissues, and organs (with focus

of corneal tissue/cells) that increases


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