Notice2024-26663
Government Owned Inventions Available for Licensing or Collaboration: Novel Kinase Inhibitory Aplithianines
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 15, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 221 (Friday, November 15, 2024)</title>
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[Federal Register Volume 89, Number 221 (Friday, November 15, 2024)]
[Notices]
[Pages 90298-90300]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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: <a href="/cdn-cgi/l/email-protection#bcc8ddcec5d292d8d5dfd7fcd2d5d492dbd3ca"><span class="__cf_email__" data-cfemail="463227343f2868222f252d06282f2e68212930">[email protected]</span></a> 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:
<bullet> Oncogenic gene fusion DNAJB1-PRKACA (PKADJ):
[cir] Implicated in an ultra-rare adolescent liver cancer.
<bullet> Wild type protein kinase A (PKA):
[cir] Implicated in Cushing's Disease.
<bullet> Protein kinase G (PKG):
[cir] Potential treatment of malaria.
<bullet> Ccdc2-like kinases (CLK) 1 and 2:
[cir] Implicated in gastric cancer.
<bullet> 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.
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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:
<bullet> Gastric cancer.
<bullet> Ultra-rare adolescent liver cancer.
<bullet> Solid cancers susceptible to kinase inhibitors.
<bullet> Cushing's Disease.
<bullet> Transplantation.
<bullet> Diabetic neuropathic pain.
<bullet> Malaria.
<bullet> Protozoa infection.
Competitive Advantages:
<bullet> 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.
<bullet> Applicable to a range of kinases, but are not promiscuous
kinase inhibitors.
<bullet> Broad potential commercial applicability for several
blockbuster indications including:
[cir] cancer, immune suppression, transplantation, diabetic
neuropathic pain, malaria, and protozoa infection.
<bullet> No approved therapeutics targeting DNAJB1-PRKCA.
Publications:
<bullet> 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, <a href="https://pubmed.ncbi.nlm.nih.gov/37082750/">https://pubmed.ncbi.nlm.nih.gov/37082750/</a>.
<bullet> 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, <a href="https://pubmed.ncbi.nlm.nih.gov/37843072/">https://pubmed.ncbi.nlm.nih.gov/37843072/</a>.
Patent Status:
<bullet> E-044-2022: PCT/US2023/070304.
<bullet> E-202-2023: PCT/US2024/038376.
<bullet> 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]
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