83 FR 29562 - Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 122 (June 25, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 122 (June 25, 2018)
| Page Range | 29562-29563 | |
| FR Document | 2018-13486 |
[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)] [Notices] [Pages 29562-29563] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13486] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY. DATES: Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences on or before July 10, 2018 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, National Center for Advancing Translational Sciences, NIH, 9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-9197, Fax: 301-217-5736, or email sury.vepa@nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Intellectual Property 1. International Application No. PCT/US15/067406 filed on 12/22/ 2015 which is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' (HHS Ref. No: E-243-2014/0-PCT-02), and 2. U.S. Provisional Application No. 62/353298 filed on 06/22/2016 which is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' (HHS Ref. No. E-189-2016/0-US-01). The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America and the University of North Carolina at Chapel Hill. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ``Therapeutics for cancers in humans which result from or characterized by the presence of mutant IDH1.'' The inventions relate to a series of novel compounds that potently and selectively inhibit mIDH1. These compounds reduce 2-HG levels in cell lines in vitro as well as in human cancer cells grown in mouse xenografts in vivo. These compounds show greater than 250-fold selectivity for the mutant enzyme over the wild-type, show favorable in vitro stability (in mouse, rat, dog and human hepatocyte exposure studies), are AMES negative, and exhibit no significant metabolic CYP liabilities. These compounds possess very favorable in vivo rodent pharmacokinetics and bioavailability and are well tolerated in rodents, even when dosed at high levels. Thus, the compounds of the subject inventions can be used individually or in combination to develop new therapies to treat diseases which result from mutant IDH1 activity. The diseases caused by mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, glioma, cholangiocarcinoma and potentially other solid tumors) and selected rare diseases, such as Ollier Disease. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless [[Page 29563]] within fifteen (15) days from the date of this published notice, the National Center for Advancing Translational Sciences receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: June 11, 2018. Christopher P. Austin, Director, Office of the Director, National Center for Advancing Translational Sciences. [FR Doc. 2018-13486 Filed 6-22-18; 8:45 am] BILLING CODE 4140-01-P
![29562 Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices
program improvements. CB encourages Field Initiated Research on Child Abuse NIH, 9800 Medical Center Drive,
research on underlying issues in and Neglect Rockville, MD 20850, Phone: 301–217–
practice areas contributing to poor The generation of new knowledge for 9197, Fax: 301–217–5736, or email
performance on CFSR outcomes. State understanding critical issues in child sury.vepa@nih.gov. A signed
performance on identifying, assessing, abuse and neglect improves prevention, Confidential Disclosure Agreement may
and addressing children’s mental needs, identification, assessment, and be required to receive copies of the
in particular, was found as an area treatment. Research areas to be patent applications.
needing improvement in the CFSRs. addressed may be those that will SUPPLEMENTARY INFORMATION:
Areas of interest for research may expand the current knowledge base,
include examining CPS procedures for Intellectual Property
build on prior research, contribute to
identifying, assessing, and responding 1. International Application No. PCT/
practice enhancements, inform policy,
to children’s mental health challenges, US15/067406 filed on 12/22/2015
improve science, and provide insights
as well as the prevalence, type, and which is entitled ‘‘Mutant IDH1
into new approaches to the assessment,
severity of mental health needs among Inhibitors Useful for Treating Cancer’’
prevention, intervention, and treatment
children identified in state child welfare (HHS Ref. No: E–243–2014/0–PCT–02),
of child maltreatment (i.e., physical and
systems. In addition, findings from the
abuse, sexual abuse, emotional 2. U.S. Provisional Application No.
National Survey of Child and
maltreatment, or neglect) on any of the 62/353298 filed on 06/22/2016 which is
Adolescent Well-Being show that high
topics listed in (A) Legislative Topics, entitled ‘‘Mutant IDH1 Inhibitors Useful
rates of mental health needs among
parents, coupled with low rates of (B) Other Topics, above, or any other for Treating Cancer’’ (HHS Ref.
identification, assessment, and referral, child maltreatment topic. In addition to No. E–189–2016/0–US–01).
is a serious issue. CB is interested in the topics cited above, practitioners and The patent rights in these inventions
research that examines support services researchers are encouraged to propose have been assigned and/or exclusively
to strengthen families, including mental other relevant subjects for research licensed to the government of the
health services to parents and children. topics in child abuse and neglect. United States of America and the
Secondary Data Analysis: CB Dated: June 19, 2018. University of North Carolina at Chapel
encourages the utilization of existing Jerry Milner, Hill.
data sources, particularly the use of Acting Commissioner, Administration on The prospective exclusive license
service data through the National Child Children, Youth and Families. territory may be worldwide and the
Abuse and Neglect Data System [FR Doc. 2018–13526 Filed 6–22–18; 8:45 am]
field of use may be limited to the use
(NCANDS) and other child welfare data of Licensed Patent Rights for the
BILLING CODE 4184–29–P
available through the National Data following: ‘‘Therapeutics for cancers in
Archive on Child Abuse and Neglect. humans which result from or
CB is interested in secondary data DEPARTMENT OF HEALTH AND characterized by the presence of mutant
analyses using NCANDS, focusing on HUMAN SERVICES IDH1.’’
service utilization, recurrence, and The inventions relate to a series of
perpetrators. National Institutes of Health novel compounds that potently and
Service utilization: While not all selectively inhibit mIDH1. These
states provide complete service data to Prospective Grant of Exclusive Patent compounds reduce 2–HG levels in cell
NCANDS, for those states that do License: Mutant IDH1 Inhibitors Useful lines in vitro as well as in human cancer
provide complete service data, the for Treating Cancer cells grown in mouse xenografts in vivo.
following areas could be examined: The These compounds show greater than
AGENCY: National Institutes of Health, 250-fold selectivity for the mutant
services that are provided to Substance
HHS. enzyme over the wild-type, show
Exposed Newborns and their families;
services to victims of human trafficking; ACTION: Notice. favorable in vitro stability (in mouse,
differences in service patterns that exist rat, dog and human hepatocyte exposure
SUMMARY: National Center for
between child victims who remain in studies), are AMES negative, and exhibit
Advancing Translational Sciences, an
their homes and those who are removed; no significant metabolic CYP liabilities.
institute of the National Institutes of
and the variations in service patterns These compounds possess very
Health, Department of Health and
within states according to county favorable in vivo rodent
Human Services, is contemplating the
characteristics. pharmacokinetics and bioavailability
Perpetrators: CB continues to be grant of an exclusive patent license to
and are well tolerated in rodents, even
interested in perpetrators, with the practice the inventions embodied in the
when dosed at high levels.
notion that understanding who this Patent Applications listed in the Thus, the compounds of the subject
group is and what their characteristics Summary Information section of this inventions can be used individually or
are can help to inform more effective notice to Apexx Oncology, Inc., located in combination to develop new
intervention and prevention efforts. in New York, NY. therapies to treat diseases which result
According to the most recent analysis of DATES: Only written comments and/or from mutant IDH1 activity. The diseases
NCANDS data, female caregivers applications for a license which are caused by mutant IDH1 activity include
between the ages of 18–30 are most received by the National Center for cancer (e.g., acute myeloid leukemia,
often identified as maltreators of Advancing Translational Sciences on or glioma, cholangiocarcinoma and
children ages birth–3. Further before July 10, 2018 will be considered. potentially other solid tumors) and
amozie on DSK3GDR082PROD with NOTICES1
exploration of these phenomena is ADDRESSES: Requests for copies of the selected rare diseases, such as Ollier
necessary to identify subgroups within patent application, inquiries, and Disease.
this population of female caregivers, to comments relating to the contemplated This notice is made in accordance
identify services that mitigate risk to exclusive license should be directed to: with 35 U.S.C. 209 and 37 CFR part 404.
infants and toddlers of young adult Sury Vepa, Ph.D., J.D., Senior Licensing The prospective exclusive license will
parents, and to develop targeted and Patenting Manager, National Center be royalty bearing, and the prospective
prevention strategies. for Advancing Translational Sciences, exclusive license may be granted unless
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![Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices 29563
within fifteen (15) days from the date of further instructions on submitting cannot be submitted using http://
this published notice, the National comments. www.regulations.gov, contact the person
Center for Advancing Translational A copy of the ICR is available through in the FOR FURTHER INFORMATION
Sciences receives written evidence and the docket on the internet at http:// CONTACT section of this document for
argument that establishes that the grant www.regulations.gov. Additionally, alternate instructions. Documents
of the license would not be consistent copies are available from: Commandant mentioned in this notice, and all public
with the requirements of 35 U.S.C. 209 (CG–612), Attn: Paperwork Reduction comments, are in our online docket at
and 37 CFR part 404. Act Manager, U.S. Coast Guard, 2703 http://www.regulations.gov and can be
Complete applications for a license in Martin Luther King Jr. Ave. SE, STOP viewed by following that website’s
the prospective field of use that are filed 7710, Washington, DC 20593–7710. instructions. Additionally, if you go to
in response to this notice will be treated FOR FURTHER INFORMATION CONTACT: Mr. the online docket and sign up for email
as objections to the grant of the Anthony Smith, Office of Information alerts, you will be notified when
contemplated Exclusive Patent License Management, telephone 202–475–3532, comments are posted.
Agreement. Comments and objections or fax 202–372–8405, for questions on We accept anonymous comments. All
submitted to this notice will not be these documents. comments received will be posted
made available for public inspection without change to http://
SUPPLEMENTARY INFORMATION:
and, to the extent permitted by law, will www.regulations.gov and will include
not be released under the Freedom of Public Participation and Request for any personal information you have
Information Act, 5 U.S.C. 552. Comments provided. For more about privacy and
Dated: June 11, 2018. This Notice relies on the authority of the docket, you may review a Privacy
Christopher P. Austin, the Paperwork Reduction Act of 1995; Act notice regarding the Federal Docket
Director, Office of the Director, National 44 U.S.C. Chapter 35, as amended. An Management System in the March 24,
Center for Advancing Translational Sciences. ICR is an application to OIRA seeking 2005, issue of the Federal Register (70
[FR Doc. 2018–13486 Filed 6–22–18; 8:45 am] the approval, extension, or renewal of a FR 15086).
BILLING CODE 4140–01–P Coast Guard collection of information Information Collection Request
(Collection). The ICR contains
information describing the Collection’s Title: Report of Oil or Hazardous
DEPARTMENT OF HOMELAND purpose, the Collection’s likely burden Substance Discharge and Report of
SECURITY on the affected public, an explanation of Suspicious Maritime Activity.
the necessity of the Collection, and OMB Control Number: 1625–0096.
Coast Guard other important information describing
Summary:Any discharge of oil or a
the Collection. There is one ICR for each
[Docket No. USCG–2018–0282] hazardous substance must be reported
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the Office of Management and Budget and (4) ways to minimize the burden of pollution spills. Title 33 CFR 101.305
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Regulatory Affairs (OIRA), requesting an including the use of automated those vessels or facilities required to
extension of its approval for the collection techniques or other forms of have security plans, report activities
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We encourage you to respond to this vessel or onshore/offshore facility;
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Frequency: On occasion.
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amozie on DSK3GDR082PROD with NOTICES1
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Guard using the Federal eRulemaking Submitting Comments to 1,980 hours a year due to a decrease
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See the ‘‘Public participation and comments through the Federal responses.
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Document Created: 2018-06-23 02:29:20
Document Modified: 2018-06-23 02:29:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences on or before July 10, 2018 will be considered. | |
| FR Citation | 83 FR 29562 |
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