Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26487 

Dated: June 1, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12175 Filed 6–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: The Development of an 

Anti-BCMA Immunotoxin for the 

Treatment of Human Cancer 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

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 

Patents and Patent Applications listed 

in the SUPPLEMENTARY INFORMATION

section of this notice to BEORO 

Therapeutics, GmbH. (‘‘Beoro’’) located 

in Seefeld, Germany. 

DATES: Only written comments and/or 

complete applications for a license 

which are received by the National 

Cancer Institute’s Technology Transfer 

Center on or before June 22, 2018 will 

be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: David A. Lambertson, Ph.D., 

Senior Technology Transfer Manager, 

NCI Technology Transfer Center, 9609 

Medical Center Drive, RM 1E530 MSC 

9702, Bethesda, MD 20892–9702 (for 

business mail), Rockville, MD 20850– 

9702 Telephone: (240)–276–5530; 

Facsimile: (240)–276–5504 Email: 

david.lambertson@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

The following represents the 

intellectual property to be licensed 

under the prospective agreement: 

U.S. Patent Application 62/255,255 

(HHS reference E–010–2016–0–US–01), 

U.S. Patent Application 62/257,493 

(HHS reference E–010–2016–1–US–01), 

and PCT Patent Application PCT/ 

US2016/061320 (HHS reference E–010– 

2016–2–PCT–01); 

U.S. Patent Application 61/887,418 

(HHS reference E–771–2013–0–US–01), 

U.S. Patent Application 61/908,464 

(HHS reference E–771–2013–1–US–01), 

U.S. Patent Application 61/982,051 

(HHS reference E–771–2013–2–US–01), 

U.S. Patent Application 61/052,665 

(HHS reference E–771–2013–3–US–01), 

PCT Application PCT/US2014/058941 

(HHS reference E–771–2013–4–PCT– 

01), U.S. Patent 9,388,222 (HHS 

reference E–771–2013–4–US–02), 

Australian Patent Application 

2014329437 (HHS reference E–771– 

2013–4–AU–08), Canadian Patent 

Application 2926215 (HHS reference E– 

771–2013–4–CA–09), Chinese Patent 

Application 201480062185.7 (HHS 

Reference E–771–2013–4–CN–10), 

European Patent Application 

14789449.7 (HHS reference E–771– 

2013–4–EP–11), Indian Patent 

Application 201647015226 (HHS 

reference E–771–2013–4–IN–12), 

Russian Patent Application 2016114406 

(HHS reference E–771–2013–4–RU–13), 

Japanese Patent Application (HHS 

reference E–771–2013–4–JP–14), and 

U.S. Patent Application 15/191,392 

(HHS reference E–771–2013–4–US–15); 

U.S. Patent Application 61/535,668 

(HHS reference E–263–2011–0–US–01), 

PCT Application PCT/US2012/055034 

(HHS reference E–263–2011–0–PCT– 

02), Australian Patent 2012308591 (HHS 

reference E–263–2011–0–AU–03), 

Canadian Patent Application 2846608 

(HHS reference E–263–2011–0–CA–04), 

European Patent 2755993 (HHS 

reference E–263–2011–0–EP–05), U.S. 

Patent 9,206,240 (HHS reference E–263– 

2011–0–US–06), Hong Kong Patent 

Application 14111650.2 (HHS reference 

E–263–2011–0–HK–07), U.S. Patent 

9,657,066 (HHS reference E–263–2011– 

0–US–08), U.S. Patent Application 15/ 

488,898 (HHS reference E–263–2011–0– 

US–09) and European Patent 

Application 14/927,645 (HHS reference 

E–263–2011–0–EP–18); 

U.S. Patent Application 61/495,085 

(HHS reference E–174–2011–0–US–01), 

PCT Application PCT/US2012/041234 

(HHS reference E–174–2011–0–PCT– 

02), Australian Patent 2012268013 (HHS 

reference E–174–2011–0–AU–03), 

Brazilian Patent Application 

112013031262–9 (HHS reference E– 

174–2011–0–BR–04), Canadian Patent 

Application 2838013 (HHS reference E– 

174–2011–0–CA–05), Chinese Patent 

Application 201280039071.1 (HHS 

reference E–174–2011–0–CN–06), 

European Patent 2718308 (HHS 

reference E–174–2011–0–EP–07) as 

validated in Germany, Spain, France, 

the United Kingdom, and Italy, Hong 

Kong Patent Application 14105911.9 

(HHS reference E–174–2011–0–HK–08), 

Japanese Patent 6100764 (HHS reference 

E–174–2011–0–JP–09), South Korean 

Patent Application 2013–7032402 (HHS 

reference E–174–2011–0–KR–10), 

Mexican Patent Application MX/a/ 

2013/014388 (HHS reference E–174– 

2011–0–MX–11), Russian Patent 

2627216 (HHS reference E–174–2011– 

0–RU–12), U.S. Patent 9,346,859 (HHS 

reference E–174–2011–0–US–13), Hong 

Kong Patent Application 14106689.7 

(HHS reference E–174–2011–0–HK–14), 

U.S. Patent 9,765,123 (HHS reference E– 

174–2011–0–US–15), Australian Patent 

Application 2017200541 (HHS reference 

E–174–2011–0–AU–16), European 

Patent Application 17163568.3 (HHS 

reference E–174–2011–0–EP–17), 

Japanese Patent Application 2017– 

031283 (HHS reference E–174–2011–0– 

JP–18), and U.S. Patent Application 15/ 

693,705 (HHS reference E–174–2011/0– 

US–24); 

U.S. Patent Application 61/241,620 

(HHS reference E–269–2009–0–US–01), 

PCT Application PCT/US2010/048504 

(HHS reference E–269–2009–0–PCT– 

02), Australian Patent 2010292069 (HHS 

reference E–269–2009–0–AU–03), 

Canadian Patent 2773665 (HHS 

reference E–269–2009–0–CA–04), 

Chinese Patent 201080049559.3 (HHS 

reference E–269–2009–0–CN–05), 

European Patent 2475398 (HHS 

reference E–269–2009–0–EP–06), as 

validated in France, Germany, Italy, 

Spain and the United Kingdom, Indian 

Patent Application 3197/CHENP/2012 

(HHS reference E–269–2009–0–IN–07), 

Japanese Patent 5795765 (HHS reference 

E–269–2009–0–JP–08), Russian Patent 

Application 2012114005 (HHS reference 

E–269–2009–0–RU–09), and U.S. Patent 

8,936,792 (HHS reference E–269–2009– 

0–US–10); 

U.S. Patent Application 60/969,929 

(HHS reference E–292–2007–0–US–01), 

PCT Application PCT/US2008/075296 

(HHS reference E–292–2007–0–PCT– 

02), Australian Patent 2008296194 (HHS 

reference E–292–2007–0–AU–03), 

Canadian Patent 2698357 (HHS 

reference E–292–2007–0–CA–04), 

European Patent 2197903 (HHS 

reference E–292–2007–0–EP–05) as 

validated in Austria, Belgium, Bulgaria, 

Switzerland, Cyprus, Germany, 

Denmark, Estonia, Spain, Finland, 

France, the United Kingdom, Greece, 

Croatia, Hungary, Ireland, Italy, 

Lithuania, Luxembourg, Latvia, Monaco, 

Malta, the Netherlands, Norway, 

Poland, Portugal, Romania, Slovenia, 

Slovakia, and Turkey, U.S. Patent 

8,871,906 (HHS reference E–292–2007– 

0–US–06), European Patent 2570425 

(HHS reference E–292–2007–0–EP–07) 

as validated in France, Germany, the 

United Kingdom, Italy and Spain, and 

Hong Kong Patent Application 

13106628.2 (HHS reference E–292– 

2007–0–HK–08); 


sradovich on DSK3GMQ082PROD with NOTICES
26488 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

U.S. Patent Application 60/703,798 

(HHS reference E–262–2005–0–US–01), 

PCT Application PCT/US2006/028986 

(HHS reference E–262–2005–0–PCT– 

02), Australian Patent 2006275865 (HHS 

reference E–262–2005–0–AU–03), 

Canadian Patent 2616987 (HHS 

reference E–262–2005–0–CA–04), 

European Patent 1910407 (HHS 

reference E–262–2005–0–EP–05) as 

validated in Switzerland, Germany, 

Spain, France, the United Kingdom, and 

Italy, U.S. Patent 8,907,060 (HHS 

reference E–262–2005–0–US–06), 

European Patent 2311854 (HHS 

reference E–262–2005–0–EP–07) as 

validated in Switzerland, Germany, 

Spain, France, the United Kingdom, and 

Italy, European Patent 2332970 (HHS 

reference E–262–2005–0–EP–08) as 

validated in Germany, Spain, France, 

the United Kingdom, and Italy, 

Australian Patent 2012216642 (HHS 

reference E–262–2005–0–AU–15), 

Australian Patent 2014208269 (HHS 

reference E–262–2005–0–AU–22), 

European Patent Application 

15191388.6 (HHS reference E–262– 

2005–0–EP–28), European Patent 

3006457 (HHS reference E–262–2005/0– 

EP–29) as validated in Austria, Belgium, 

Germany, Spain, France, the United 

Kingdom, Ireland, Italy, the 

Netherlands, and Poland, European 

Patent 3006458 (HHS reference E–262– 

2005–0–EP–30) as validated in Austria, 

Belgium, Germany, Spain, France, the 

United Kingdom, Ireland, Italy, the 

Netherlands, and Poland, Australian 

Patent 2016202754 (HHS reference E– 

262–2005–0–AU–31), and Canadian 

Patent Application 2941466 (HHS 

reference E–262–2005/0–CA–32); 

and all continuing applications and 

foreign counterparts to the patents and 

applications listed above for each 

technology. 

With respect to persons who have an 

obligation to assign their right, title and 

interest to the Government of the United 

States of America, the patent rights in 

these inventions have been assigned to 

the Government of the United States of 

America. 

The prospective exclusive license 

territory may be worldwide and the 

field of use may be limited to the 

following: 

‘‘The development and commercialization 

of a monospecific BCMA-targeted 

immunotoxin, whereby the immunotoxin is 

comprised of: 

(1) the complementary determining region 

(CDR) sequences of either 

i. the anti-BCMA antibody known as 

BM24; or 

ii. the anti-BCMA antibody known as 

BM306; and 

(2) a Pseudomonas Exotoxin A-based 

payload consisting of a PE25 variant with or 

without alterations of one or more amino 

acids in one or more B cell and/or T cell 

epitopes. 

for the treatment of hematological 

malignancies.’’ 

The E–010–2016 technology discloses 

antibodies that recognize the BCMA (B 

Cell Maturation Antigen) protein. 

BCMA is expressed on the cell surface 

of several forms of cancer, most notably 

multiple myeloma. Although these 

BCMA antibodies can potentially be 

used in many therapeutic formats (e.g., 

unconjugated antibodies, bispecific 

antibodies (and variants thereof), 

antibody-drug conjugates (ADCs), 

chimeric antigen receptors (CARs), etc., 

to target cancer cells for destruction, the 

contemplated field of use only concerns 

the development of one specific format 

(recombinant immunotoxins) using one 

type of toxin variant (Pseudomonas 

Exotoxin A variants). Many other 

formats, and therefore fields of use, 

remain available for licensing and 

development. 

The E–263–2011–0, E–174–2011–0, 

E–269–2009–0, E–292–2007, E–262– 

2005–0 and E–771–2013–0–5 

technologies (i.e., ‘‘non-E–010–2016–0 

technologies’’) all concern distinct 

variants of Pseudomonas Exotoxin A 

which can be used in the BCMAtargeted immunotoxin. The 

Pseudomonas Exotoxin A variants 

represent the ‘‘payload’’ portion of the 

immunotoxin, which is the portion that 

instigates the destruction of the cancer 

cells that are targeted by the 

aforementioned BCMA antibodies. 

The development of a new 

therapeutic targeting BCMA will benefit 

public health by offering up a treatment 

for these cancers in instances when 

conventional first line therapies are 

ineffective. 

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 

within fifteen (15) days from the date of 

this published notice, the National 

Cancer Institute 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. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a completed license 

application, will not be treated 

confidentially, and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: June 1, 2018. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2018–12179 Filed 6–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice to Close Meeting 

Pursuant to section 10(d) 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 Institute of 

Nursing Research Special Emphasis Panel; 

Multicenter Clinical Grants. 

Date: June 6, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Tamizchelvi Thyagarajan, 

Ph.D., Scientific Review Officer, National 

Institute of Nursing Research, National 

Institutes of Health, 6701 Democracy 

Boulevard, Bethesda, MD 20892, (301) 594– 

0343, Tamizchelvi.thagarajan@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: June 1, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12178 Filed 6–6–18; 8:45 am] 

BILLING CODE 4140–01–P 


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