Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38711 

Confidential Disclosure Agreement may 

be required to receive any unpublished 

information. 

SUPPLEMENTARY INFORMATION: This 

notice is in accordance with 35 U.S.C. 

209 and 37 CFR part 404 to achieve 

commercialization of results of 

federally-funded research and 

development. 

Technology description follows. 

Albumin Binding Prostate Cancer 

Treating Compositions 

The invention pertains to a 

therapeutic agent that includes a 

chemically conjugated residue derived 

from (((R-)-1-carboxy-2- 

mercaptoethyl)carbamoyl)-L-glutamic 

acid that is further bound to an Evans 

blue analog (EB). The EB analog 

reversibly binds to circulating serum 

albumin to provide a 

radiopharmaceutical that retains affinity 

and specificity to prostate specific 

membrane antigen (PSMA; in this case 

PSMA–617). PSMA is a surface 

molecule shown to be specifically 

expressed by prostate tumor cells. 

PSMA expression levels correlate with 

disease stage and with hormone 

refractory cancers. Although most 

PSMA expression appears to be 

restricted to the prostate cancer, low 

levels of expression can also be detected 

in the brain, kidneys, salivary glands, 

and small intestine. The antigen is also 

shown to be expressed by neovascular 

tumor vessels of multiple other cancers. 

Inclusion of the Evans blue analog 

promotes high internalization and 

retention rates of the conjugated target 

ligand, and therefore, higher 

accumulation in PSMA positive tumors. 

Labeling EB–PSMA–617 derivatives 

with the therapeutic beta emitters, e.g., 

90Y, 86Y, and 177Lu gives rise to 

improved tumor response and survival 

rates. 

Potential Commercial Applications: 

• Cancer therapeutics 

• Higher stability/Lower toxicity 

Development Stage: 

• Early stage 

Inventors: Xiaoyuan Chen and Orit 

Jacobson Weiss (both of NIBIB). 

Intellectual Property: HHS Reference 

No. E–054–2018/0; U.S. Provisional 

Patent Applications 62/633,648 filed 

February 22, 2018. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@mail.nih.gov. 

Dated: July 20, 2018. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2018–16838 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

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: 

Barry Buchbinder, Ph.D., 240–627– 

3678; barry.buchbinder@nih.gov. 

Licensing information and copies of the 

U.S. patent application 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. 

Self-Assembling Insect Ferritin 

Nanoparticles for Display of Coassembled Trimeric Antigens 

Description of Technology 

Antigens on the surface of virus 

particles are displayed in a regular, 

repetitive pattern which facilitates B 

cell activation. Presenting trimeric 

antigens on engineered particles that 

mimic the geometric patterns observed 

for native viral proteins can lead to an 

improved host antibody response. 

Self-assembling globular ferritin 

nanoparticles have previously been 

used to display multiple copies of a coassembled trimeric antigen to the 

immune system. However, prior ferritin 

nanoparticle technologies only permit a 

random co-assembly of diverse trimeric 

antigens, and therefore cannot guarantee 

the pattern and ratio of diverse trimeric 

antigens on a single ferritin 

nanoparticle. 

Researchers at the Vaccine Research 

Center (VRC) of the National Institute of 

Allergy and Infectious Diseases are 

developing novel recombinant ferritin 

nanoparticles that are based on insect 

ferritin proteins, and that have been 

engineered to display two different 

trimeric antigens in a defined ratio and 

geometric pattern. This system has been 

tested with antigens derived from HIV– 

1 envelope (Env) and influenza 

hemagglutinin (HA). Interestingly, when 

guinea pigs are immunized with ferritin 

nanoparticles displaying two different 

trimeric antigens, induced B cells could 

simultaneously recognize both trimeric 

antigens, thus leading to an immune 

response with improved neutralization 

breadth. 

This technology can be used as a 

platform for multimerized display of 

trimeric antigens such as viral type I 

fusion glycoproteins, and may be 

applied to many high-priority vaccine 

targets, such as HIV–1, influenza, 

respiratory syncytial virus, 

parainfluenza viruses, and 

coronaviruses. 

Potential Commercial Applications: 

• Platform for multimerized 

immunogen presentation and vaccine 

design. 

• Vaccines for pathogens that use 

genetic diversity to escape the immune 

response. 

Competitive Advantages: 

• Particles have equal fractions of two 

different antigens in a specific 

configuration on the nanoparticle 

surface (unlike regular ferritin used 

previously) 

• Designed particles have a geometry 

that allows for attachment of trimeric 

antigens (unlike the native insect 

ferritin). 

Development Stage: 

• In vivo testing (rodents). 

Inventors: Peter Kwong (NIAID), 

Ivelin Georgiev (NIAID), Michael 

Gordon Joyce (NIAID), Masaru Kanekiyo 

(NIAID), Aliaksandr Druz (NIAID), 

Ulrich Baxa (NIAID), Joseph Van Galen 

(NIAID), Rita Chen (NIAID), Cheng 

Cheng (NIAID), John Mascola (NIAID), 

Yaroslav Tsybovsky (Leidos Biomedical 

Research, Inc), Yongping Yang (NIAID), 

Paul Thomas (NIAID), Barney Graham 

(NIAID). 

Publications: Georgiev, Ivelin S., et 

al., ACS Infectious Diseases (2018) 4 (5), 

788–796. 

Intellectual Property: HHS Reference 

Number E–270–2015: U.S. Patent 

Application No. 62/355,212 filed 06/27/ 


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38712 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

2016; PCT Application No. PCT/ 

US2017/039595 filed 06/27/2017 

(pending). 

Related Intellectual Property: HHS 

Reference Number E–531–2013, E–293– 

2011, E–060–2015. 

Licensing Contact: Barry Buchbinder, 

Ph.D., 240–627–3678; 

barry.buchbinder@nih.gov. 

Dated: July 20, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–16841 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Scientific Advisory Committee on 

Alternative Toxicological Methods; 

Announcement of Meeting; Request 

for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the Scientific Advisory 

Committee on Alternative Toxicological 

Methods (SACATM). SACATM, a 

federally chartered, external advisory 

group composed of scientists from the 

public and private sectors, including 

representatives of regulated industry 

and national animal protection 

organization, will review and provide 

advice on programmatic activities. 

SACATM advises the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM), the National Toxicology 

Program (NTP) Interagency Center for 

the Evaluation of Alternative 

Toxicological Methods (NICEATM), and 

the Director of the National Institute of 

Environmental Sciences (NIEHS) and 

NTP regarding statutorily mandated 

duties of ICCVAM and activites of 

NICEATM. The meeting is open to the 

public and registration is requested for 

both attendance and oral comment and 

required to access the webcast. 

Information about the meeting and 

registration are available at https://

ntp.niehs.nih.gov/go/32822. 

DATES: 

Meeting: September 5–6, 2018; Begins 

at 9:00 a.m. (EDT) each day and 

continues until adjournment. 

Written Public Comment 

Submissions: Deadline is August 29, 

2018. 

Oral Comments: Deadline is August 

29, 2018. 

Registration for Meeting: Deadline 

September 6, 2018. 

Registration to view the meeting via 

the webcast is required. 

ADDRESSES: 

Meeting Location: Rodbell 

Auditorium, Rall Building, National 

Institute of Environmental Health 

Sciences (NIEHS), 111 T.W. Alexander 

Drive, Research Triangle Park, NC 

27709. 

Meeting web page: The preliminary 

agenda, registration, and other meeting 

materials are at https://

ntp.niehs.nih.gov/go/32822. 

Webcast: The meeting will be 

webcast; the URL will be provided to 

those who register for viewing. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Mary Wolfe, Designated Federal Official 

for the SACATM, Office of Liaison, 

Policy and Review, Division of NTP, 

NIEHS, P.O. Box 12233, K2–03, 

Research Triangle Park, NC 27709. 

Phone: 984–287–3209, Fax: 301–451– 

5759, Email: wolfe@niehs.nih.gov. Hand 

Deliver/Courier address: 530 Davis 

Drive, Room K2130, Morrisville, NC 

27560. 

SUPPLEMENTARY INFORMATION: 

Meeting and Registration: The 

meeting is open to the public with time 

scheduled for oral public comments; 

attendance at the meeting is limited 

only by the space available. 

SACATM will provide input to 

ICCVAM, NICEATM, and NIEHS on 

programmatic activities and issues. 

Preliminary agenda includes the US 

Strategic Roadmap including challenges 

to and opportunities for implementing 

non-animal approaches to evaluate 

chemicals and medical products and the 

importance of international 

harmonization through the Organisation 

for Economic Co-operation and 

Development activites. Please see the 

preliminary agenda for information 

about the specific presentations. The 

preliminary agenda, roster of SACATM 

members, background materials, public 

comments, and any additional 

information, when available, will be 

posted on the SACATM meeting website 

(https://ntp.niehs.nih.gov/go/32822) or 

may be requested in hardcopy from the 

Designated Federal Official for 

SACATM. Following the meeting, 

summary minutes will be prepared and 

made available on the BSC meeting 

website. 

The public may attend the meeting in 

person or view the webcast. Registration 

is required to view the webcast; the URL 

for the webcast will be provided in the 

email confirming registration. 

Individuals who plan to provide oral 

comments (see below) are encouraged to 

register online at the SACATM meeting 

website (https://ntp.niehs.nih.gov/go/ 

32822) by August 29, 2018, to facilitate 

planning for the meeting. Individuals 

are encouraged to access the website to 

stay abreast of the most current 

information regarding the meeting. 

Visitor and security information for 

those attending in-person is available at 

niehs.nih.gov/about/visiting/index.cfm. 

Individuals with disabilities who need 

accommodation to participate in this 

event should contact Ms. Robbin Guy at 

phone: (984) 287–3136 or email: guyr2@

niehs.nih.gov. TTY users should contact 

the Federal TTY Relay Service at 800– 

877–8339. Requests should be made at 

least five business days in advance of 

the event. 

Written Public Comments: Written 

and oral public comment are invited for 

the agenda topics. Guidelines for public 

comments are available at https://

ntp.niehs.nih.gov/ntp/about_ntp/ 

guidelines_public_comments_508.pdf. 

The deadline for submission of 

written comments is August 29, 2018. 

Written public comments should be 

submitted through the meeting website. 

Persons submitting written comments 

should include name, affiliation, 

mailing address, phone, email, and 

sponsoring organization (if any). Written 

comments received in response to this 

notice will be posted on the NTP 

website, and the submitter will be 

identified by name, affiliation, and 

sponsoring organization (if any). 

Oral Public Comment Registration: 

The preliminary agenda allows for 

several public comment periods with 

each allowing for up to 4 commenters 

for up to 5 minutes per speaker. Oral 

comments may be presented in person 

at NIEHS or by teleconference line. 

Registration for oral comments is on or 

before August 29, 2018, at https://

ntp.niehs.nih.gov/go/32822. Registration 

is on a first-come, first-served basis, and 

registrants will be assigned a number in 

their confirmation email. Each 

organization is allowed one time slot 

per comment period. After the 

maximum number of speakers per 

comment period is exceeded, 

individuals registered to provide oral 

comment will be placed on a wait list 

and notified should an opening become 

available. Commenters will be notified 

after August 29, 2018, about the actual 

time allotted per speaker, and the 

teleconference number will be sent to 

those registered to give oral comments 

by teleconference line. 

If possible, oral public commenters 

should send a copy of their slides and/ 

or statement or talking points to Robbin 


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