82 FR 27068 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 112 (June 13, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 112 (June 13, 2017)
| Page Range | 27068-27069 | |
| FR Document | 2017-12147 |
[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)] [Notices] [Pages 27068-27069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12147] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Dr. Natalie Greco, 301-761-7898; [email protected]. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Human and Veterinary Cancer Therapeutic Agent Utilizing Anthrax Toxin- Based Technology Description of Technology Due to the disorganized nature of blood vessels that run through tumors, chemotherapeutic agents often fail to penetrate tumors and kill cancer cells at the tumor's center. This can lead to ineffective chemotherapeutic treatments, because tumors can quickly grow back if the entire tumor is not destroyed. NIH researchers have developed a therapeutic agent that solves this problem facing current chemotherapy treatments. By elegantly [[Page 27069]] exploiting cell surface proteases present at high levels in tumors, they have developed a tumor-targeted anthrax based toxin that inactivates the blood vessels within tumors. While in some cases cancer cells are also killed by the tumor-targeted toxin, the primary mechanism of action is thought to be a decrease in blood flow to the center of tumors, causing cancer cell death and tumor necrosis. Preliminary and on-going studies have demonstrated that the targeted toxins have antitumor effects on melanomas, lung cancers and colon cancer in mouse models, and on feline and canine oral tumors. Interestingly, this therapy does not target a specific type of cancer cell, rather it targets the vasculature in and around tumors. Therefore, it has great potential to treat a wide range of solid tumors. Additionally, because few non-surgical treatments are available to treat many human and veterinary solid tumors, this technology would fill an unmet need in cancer therapy. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications Therapeutic agent for a wide range of human and veterinary solid tumors, including:Melanomas Lung and colon cancers Oral squamous carcinomas Competitive Advantages Proven effective in a variety of models, including models of important veterinary cancers. Agent is only active in tumor micro-environments, resulting in low toxicity to healthy tissue. Cancer cells are not directly targeted, so this agent can be used to treat a broad spectrum of solid tumors and resistance is unlikely to arise. Fills an unmet need in cancer therapy, because few non- surgical treatments exist. Development Stage in vitro data available in vivo data available (animal) prototype Inventors: S. Leppla (NIAID); S.-H. Liu (NIAID); T. Bugge (NIDCR); A.Wein (NIAID); D. Peters (NIDCR); J. Liu (NHLBI); K.-H.Chen (NIAID); H. Birkedal-Hansen (NIDCR); S. Netzel-Arnett (NIDCR); D. Phillips (NIAID); C. Leysath (NIAID); C. Bachran (NIAID) Publications Chen KH, et al., Selection of anthrax toxin protective antigen variants that discriminate between the cellular receptors tem8 and cmg2 and achieve targeting of tumor cells. J Biol Chem. 2007 Mar 30; 282(13): 9834-9845 [PMID: 17251181 PMCID: PMC2530824] Liu S, et al., Solid tumor therapy by selectively targeting stromal endothelial cells. Proc Natl Acad Sci U S A. 2016 Jul 12; 113(28): E4079-E4087 [PMID: 27357689 PMCID: PMC4948345] Wein AN, et al., An anthrax toxin variant with an improved activity in tumor targeting. Sci Rep. 2015; 5: 16267 [PMID: 26584669 PMCID: PMC4653645] Peters DE, et al., Comparative toxicity and efficacy of engineered anthrax lethal toxin variants with broad anti-tumor activities. Toxicol Appl Pharmacol. 2014 Sep 1; 279(2): 220-229 [PMID: 24971906 PMCID: PMC4137396] Bachran C, et al., Cytolethal distending toxin B as a cell-killing component of tumor-targeted anthrax toxin fusion proteins. Cell Death Dis. 2014 Jan; 5(1): e1003 [PMID: 24434511 PMCID: PMC4040664] Wein AN, et al., Tumor therapy with a urokinase plasminogen activator- activated anthrax lethal toxin alone and in combination with paclitaxel. Invest New Drugs. 2013 Feb; 31(1): 206-212 [PMID: 22843210 PMCID: PMC3757568] Phillips DD, et al., Engineering Anthrax Toxin Variants That Exclusively Form Octamers and Their Application to Targeting Tumors. J Biol Chem. 2013 Mar 29; 288(13): 9058-9065 [PMID: 23393143 PMCID: PMC3610978] Liu S, et al., Intermolecular complementation achieves high specificity tumor targeting by anthrax toxin. Nat Biotechnol. 2005 Jun; 23(6): 725- 730 [PMID: 15895075 PMCID: PMC2405912] Intellectual Property HHS E-256-2015--US Application Nos. 62/210,771, filed 27 Aug 2015; 62/ 323,218, filed 15 Apr 2016; PCT App. No. PCT/US16/48706, filed 25 Aug 2016. HHS E-120-2013--US App. No. 14/898,248, filed 14 Dec 2015; PCT App. No. PCT/US2014/043131, filed 19 Jun 2014. HHS E-246-2012--US App. No. 14/423,408, filed 23 Feb 2015; PCT App. No. PCT/US13/56205 HHS E-059-2004--US Patent No. 7,947,289, filed 09 Feb 2005. HHS E-293-1999--US Patent Nos. 7,468,352, filed 22 Mar 2002; 8,791,074, filed 20 Oct 2008, and 9,403,872 filed 24 Jun 2014. Licensing Contact: Dr. Natalie Greco, 301-761-7898; [email protected]. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize anthrax toxin-based cancer therapeutics. For collaboration opportunities, please contact Dr. Natalie Greco, 301-761-7898; [email protected]. Dated: June 1, 2017. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2017-12147 Filed 6-12-17; 8:45 am] BILLING CODE 4140-01-P
![27068 Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
entities to meet requirements that are at ++ The comparability of AOA– with a subsequent document, we will
least as stringent as the Medicare HFAP’s processes to those of State respond to the comments in the
conditions. Our regulations concerning agencies, including survey frequency, preamble to that document.
the approval of AOs are set forth at and the ability to investigate and Dated: June 7, 2017.
§ 488.5. respond appropriately to complaints Seema Verma,
against accredited facilities.
II. CMS Approval of Accreditation Administrator, Centers for Medicare &
++ AOA–HFAP’s processes and
Organizations Medicaid Services.
procedures for monitoring an ASC
Section 1865(a)(2) of the Act and our [FR Doc. 2017–12193 Filed 6–12–17; 8:45 am]
found out of compliance with AOA–
regulations at § 488.5 require that our HFAP’s program requirements. These BILLING CODE 4120–01–P
findings concerning review and monitoring procedures are used only
approval of an AO’s requirements when AOA–HFAP identifies
consider, among other factors, the DEPARTMENT OF HEALTH AND
noncompliance. If noncompliance is
applying AO’s requirements for HUMAN SERVICES
identified through validation reviews or
accreditation; survey procedures; complaint surveys, the State survey National Institutes of Health
resources for conducting required agency monitors corrections as specified
surveys; capacity to furnish information at § 488.9(c)(1). Government-Owned Inventions;
for use in enforcement activities; ++ AOA–HFAP’s capacity to report Availability for Licensing
monitoring procedures for provider deficiencies to the surveyed facilities
entities found not in compliance with and respond to the facility’s plan of AGENCY: National Institutes of Health,
the conditions or requirements; and correction in a timely manner. HHS.
ability to provide CMS with the ++ AOA–HFAP’s capacity to provide ACTION: Notice.
necessary data for validation. CMS with electronic data and reports
Section 1865(a)(3)(A) of the Act necessary for effective validation and SUMMARY: The invention listed below is
further requires that we publish, within assessment of the organization’s survey owned by an agency of the U.S.
60 days of receipt of an organization’s process. Government and is available for
complete application, a notice ++ The adequacy of AOA–HFAP’s licensing to achieve expeditious
identifying the national accrediting staff and other resources, and its commercialization of results of
body making the request, describing the financial viability. federally-funded research and
nature of the request, and providing at ++ AOA–HFAP’s capacity to development. Foreign patent
least a 30-day public comment period. adequately fund required surveys. applications are filed on selected
We have 210 days from the receipt of a ++ AOA–HFAP’s policies with inventions to extend market coverage
complete application to publish notice respect to whether surveys are for companies and may also be available
of approval or denial of the application. announced or unannounced, to assure for licensing.
The purpose of this notice of that surveys are unannounced. FOR FURTHER INFORMATION CONTACT: Dr.
proposed recognition is to inform the ++ AOA–HFAP’s agreement to Natalie Greco, 301–761–7898;
public of the American Osteopathic provide CMS with a copy of the most Natalie.Greco@nih.gov. Licensing
Association/Healthcare Facilities current accreditation survey, together information and copies of the patent
Accreditation Program’s (AOA–HFAP’s) with any other information related to applications listed below may be
request for continued CMS approval of the survey as CMS may require obtained by communicating with the
its ASC accreditation program. This (including corrective action plans). indicated licensing contact at the
notice also solicits public comment on Upon completion of our evaluation, Technology Transfer and Intellectual
whether AOA–HFAP’s requirements including evaluation of comments Property Office, National Institute of
meet or exceed the Medicare conditions received as a result of this notice, we Allergy and Infectious Diseases, 5601
for coverage (CfCs) for ASCs. will publish a final notice in the Federal Fishers Lane, Rockville, MD 20852; tel.
Register announcing the result of our 301–496–2644. A signed Confidential
III. Evaluation of an AO’s Accreditation evaluation. Disclosure Agreement will be required
Program
IV. Collection of Information to receive copies of unpublished patent
AOA–HFAP submitted all the applications.
necessary materials to enable us to make Requirements
SUPPLEMENTARY INFORMATION:
a determination concerning its request This document does not impose
Technology description follows.
for continued CMS approval of its ASC information collection requirements,
accreditation program. This application that is, reporting, recordkeeping or Human and Veterinary Cancer
was determined to be complete on April third-party disclosure requirements. Therapeutic Agent Utilizing Anthrax
14, 2017. Under section 1865(a)(2) of the Consequently, there is no need for Toxin-Based Technology
Act and our regulations at § 488.5, our review by the Office of Management and
Description of Technology
review and evaluation of AOA–HFAP Budget under the authority of the
will be conducted in accordance with, Paperwork Reduction Act of 1995 (44 Due to the disorganized nature of
but not necessarily limited to, the U.S.C. 3501 et seq.). blood vessels that run through tumors,
following factors: chemotherapeutic agents often fail to
V. Response to Public Comments
• The equivalency of AOA–HFAP’s penetrate tumors and kill cancer cells at
standards for ASCs as compared with Because of the large number of public the tumor’s center. This can lead to
nlaroche on DSK30NT082PROD with NOTICES
Medicare’s CfCs for ASCs. comments we normally receive on ineffective chemotherapeutic
• AOA–HFAP’s survey process to Federal Register documents, we are not treatments, because tumors can quickly
determine the following: able to acknowledge or respond to them grow back if the entire tumor is not
++ The composition of the survey individually. We will consider all destroyed. NIH researchers have
team, surveyor qualifications, and the comments we receive by the date and developed a therapeutic agent that
ability of the organization to provide time specified in the DATES section of solves this problem facing current
continuing surveyor training. this preamble, and, when we proceed chemotherapy treatments. By elegantly
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![Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices 27069
exploiting cell surface proteases present Publications HHS E–293–1999—US Patent Nos.
at high levels in tumors, they have Chen KH, et al., Selection of anthrax 7,468,352, filed 22 Mar 2002;
developed a tumor-targeted anthrax toxin protective antigen variants 8,791,074, filed 20 Oct 2008, and
based toxin that inactivates the blood that discriminate between the 9,403,872 filed 24 Jun 2014.
vessels within tumors. While in some cellular receptors tem8 and cmg2 Licensing Contact: Dr. Natalie Greco,
cases cancer cells are also killed by the and achieve targeting of tumor cells. 301–761–7898; Natalie.Greco@nih.gov.
tumor-targeted toxin, the primary J Biol Chem. 2007 Mar 30; 282(13):
mechanism of action is thought to be a Collaborative Research Opportunity:
9834–9845 [PMID: 17251181
decrease in blood flow to the center of The National Institute of Allergy and
PMCID: PMC2530824]
tumors, causing cancer cell death and Liu S, et al., Solid tumor therapy by Infectious Diseases is seeking statements
tumor necrosis. Preliminary and on- selectively targeting stromal of capability or interest from parties
going studies have demonstrated that endothelial cells. Proc Natl Acad interested in collaborative research to
the targeted toxins have antitumor Sci U S A. 2016 Jul 12; 113(28): further develop, evaluate or
effects on melanomas, lung cancers and E4079–E4087 [PMID: 27357689 commercialize anthrax toxin-based
colon cancer in mouse models, and on PMCID: PMC4948345] cancer therapeutics. For collaboration
feline and canine oral tumors. Wein AN, et al., An anthrax toxin opportunities, please contact Dr. Natalie
Interestingly, this therapy does not variant with an improved activity in Greco, 301–761–7898; Natalie.Greco@
target a specific type of cancer cell, tumor targeting. Sci Rep. 2015; 5: nih.gov.
rather it targets the vasculature in and 16267 [PMID: 26584669 PMCID: Dated: June 1, 2017.
around tumors. Therefore, it has great PMC4653645] Suzanne Frisbie,
potential to treat a wide range of solid Peters DE, et al., Comparative toxicity
tumors. Additionally, because few non- and efficacy of engineered anthrax Deputy Director, Technology Transfer and
lethal toxin variants with broad Intellectual Property Office, National Institute
surgical treatments are available to treat
of Allergy and Infectious Diseases.
many human and veterinary solid anti-tumor activities. Toxicol Appl
[FR Doc. 2017–12147 Filed 6–12–17; 8:45 am]
tumors, this technology would fill an Pharmacol. 2014 Sep 1; 279(2):
unmet need in cancer therapy. 220–229 [PMID: 24971906 PMCID: BILLING CODE 4140–01–P
This technology is available for PMC4137396]
licensing for commercial development Bachran C, et al., Cytolethal distending
in accordance with 35 U.S.C. 209 and 37 toxin B as a cell-killing component DEPARTMENT OF HEALTH AND
CFR part 404, as well as for further of tumor-targeted anthrax toxin HUMAN SERVICES
development and evaluation under a fusion proteins. Cell Death Dis.
2014 Jan; 5(1): e1003 [PMID: National Institutes of Health
research collaboration.
24434511 PMCID: PMC4040664]
Potential Commercial Applications Wein AN, et al., Tumor therapy with a Office of the Director; Notice of Charter
urokinase plasminogen activator- Renewal
Therapeutic agent for a wide range of
human and veterinary solid tumors, activated anthrax lethal toxin alone
and in combination with paclitaxel. In accordance with Title 41 of the
including: U.S. Code of Federal Regulations,
Invest New Drugs. 2013 Feb; 31(1):
• Melanomas Section 102–3.65(a), notice is hereby
206–212 [PMID: 22843210 PMCID:
• Lung and colon cancers PMC3757568] given that the Charter for the Advisory
• Oral squamous carcinomas Phillips DD, et al., Engineering Anthrax Committee to the Director, National
Toxin Variants That Exclusively Institutes of Health, was renewed for an
Competitive Advantages
Form Octamers and Their additional two-year period on May 31,
• Proven effective in a variety of Application to Targeting Tumors. J 2017.
models, including models of important Biol Chem. 2013 Mar 29; 288(13): It is determined that the Advisory
veterinary cancers. 9058–9065 [PMID: 23393143 Committee to the Director, National
• Agent is only active in tumor micro- PMCID: PMC3610978] Institutes of Health, is in the public
environments, resulting in low toxicity Liu S, et al., Intermolecular interest in connection with the
to healthy tissue. complementation achieves high performance of duties imposed on the
• Cancer cells are not directly specificity tumor targeting by National Institutes of Health by law, and
targeted, so this agent can be used to anthrax toxin. Nat Biotechnol. 2005 that these duties can best be performed
treat a broad spectrum of solid tumors Jun; 23(6): 725–730 [PMID: through the advice and counsel of this
and resistance is unlikely to arise. 15895075 PMCID: PMC2405912] group.
• Fills an unmet need in cancer Intellectual Property Inquiries may be directed to Jennifer
therapy, because few non-surgical Spaeth, Director, Office of Federal
treatments exist. HHS E–256–2015—US Application Nos.
62/210,771, filed 27 Aug 2015; 62/ Advisory Committee Policy, Office of
Development Stage 323,218, filed 15 Apr 2016; PCT App. the Director, National Institutes of
No. PCT/US16/48706, filed 25 Aug Health, 6701 Democracy Boulevard,
• in vitro data available Suite 1000, Bethesda, Maryland 20892
2016.
• in vivo data available (animal) HHS E–120–2013—US App. No. 14/ (Mail code 4875), Telephone (301) 496–
• prototype 898,248, filed 14 Dec 2015; PCT App. 2123, or spaethj@od.nih.gov.
nlaroche on DSK30NT082PROD with NOTICES
Inventors: S. Leppla (NIAID); S.-H. No. PCT/US2014/043131, filed 19 Jun Dated: June 7, 2017.
Liu (NIAID); T. Bugge (NIDCR); A.Wein 2014.
(NIAID); D. Peters (NIDCR); J. Liu Jennifer Spaeth,
HHS E–246–2012—US App. No. 14/
(NHLBI); K.-H.Chen (NIAID); H. 423,408, filed 23 Feb 2015; PCT App. Director, Office of Federal Advisory
Birkedal-Hansen (NIDCR); S. Netzel- No. PCT/US13/56205 Committee Policy.
Arnett (NIDCR); D. Phillips (NIAID); C. HHS E–059–2004—US Patent No. [FR Doc. 2017–12143 Filed 6–12–17; 8:45 am]
Leysath (NIAID); C. Bachran (NIAID) 7,947,289, filed 09 Feb 2005. BILLING CODE 4140–01–P
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Document Created: 2017-06-13 00:21:54
Document Modified: 2017-06-13 00:21:54
| 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. | |
| Contact | Dr. Natalie Greco, 301-761-7898; [email protected] Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. | |
| FR Citation | 82 FR 27068 |
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