Government Owned Inventions Available for Licensing or Collaboration: Novel Kinase Inhibitory Aplithianines, 90298-90300 [2024-26663]

Download as PDF 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] Government and are available for licensing and/or collaboration to achieve expeditious commercialization of results of federally-funded research and development. BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: 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. 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:11 Nov 14, 2024 Jkt 265001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 E:\FR\FM\15NON1.SGM 15NON1 Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices Structural Reoresentatives: Aplithianines A 90299 Aplithianines B 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. (I) NIH Reference Number: E-202-2023 patent family ("Second Cohort") The claims are directed to compositions of matter encompassing these broad Markush structures. (It) (1) XrNH ,::7" N ~,JlR, (Ia) BILLING CODE 4140–01–C VerDate Sep<11>2014 16:11 Nov 14, 2024 The specificity of several of the compounds have been examined in Jkt 265001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 kinase panels to demonstrate that while applicable to a range of kinases, they are E:\FR\FM\15NON1.SGM 15NON1 EN15NO24.000</GPH> khammond on DSKJM1Z7X2PROD with NOTICES NIH Reference Number: E-162-2024 Patent family ("'Third Cohort") The claims are directed to compositions of matter encompassing this broad Markush structures. khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 16:11 Nov 14, 2024 Jkt 265001 • 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 Government Owned Inventions Available for Licensing or Collaboration: Improved Methods for Cryopreservation of Cells, Tissues, and Organs AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES 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] PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 ACTION: Notice. 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 12day 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 SUMMARY: National Institutes of Health BILLING CODE 4140–01–P National Institutes of Health, HHS. E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 89, Number 221 (Friday, November 15, 2024)]
[Notices]
[Pages 90298-90300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26663]


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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: [email protected] 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 pre-fractionated 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):
    [cir] Implicated in an ultra-rare adolescent liver cancer.
     Wild type protein kinase A (PKA):
    [cir] Implicated in Cushing's Disease.
     Protein kinase G (PKG):
    [cir] Potential treatment of malaria.
     Ccdc2-like kinases (CLK) 1 and 2:
    [cir] Implicated in gastric cancer.
     DYRK family of kinases:
    [cir] 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

[[Page 90299]]

[GRAPHIC] [TIFF OMITTED] TN15NO24.000

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

[[Page 90300]]

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:
    [cir] Oncogenic gene fusion DNAJB1-PRKACA (PKADJ).
    [cir] Wild type protein kinase A (PKA).
    [cir] Protein kinase G (PKG).
    [cir] Ccdc2-like kinases (CLK) 1 and 2.
    [cir] 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:
    [cir] 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 Monophosphate-Dependent 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

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