Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 8263 

Advisory Committee. This meeting was 

announced in the Federal Register of 

November 17, 2011 (76 FR 71349). The 

amendment is being made to reflect a 

change in the Date and Time, Agenda, 

and Procedure portions of the 

document. We are cancelling (Topic 1), 

the portion of the meeting relating to the 

appropriate types of clinical evidence 

for developing anti-inflammatory drugs 

for the treatment of postoperative 

inflammation and reduction of ocular 

(eye) pain in patients who have 

undergone ocular surgery. The portion 

of the meeting (Topic 2), relating to the 

appropriateness of marketing a single 

bottle of anti-inflammatory ophthalmic 

products for use in both eyes for postsurgical indications as it relates to the 

potential risk for infection will still be 

held on the same date (February 27, 

2012), the time for the meeting has been 

changed to 9 a.m. to 3 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Yvette Waples, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. WO31–2417, Silver 

Spring, MD 20993–0002, 301–796–9001, 

Fax: 301–847–8533, email: 

DODAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301 443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 17, 2011, 

FDA announced that a meeting of the 

Dermatologic and Ophthalmic Drugs 

Advisory Committee would be held on 

February 27, 2012. On page 71349, in 

the first column, the Date and Time 

portion of the document is changed to 

read as follows: 

Date and Time: The meeting will be 

held on February 27, 2012, from 9 a.m. 

to 3 p.m. 

On page 71349, in the second column, 

the Agenda portion of the document is 

changed to read as follows: 

Agenda: The committee will be asked 

to comment on the appropriateness of 

marketing a single bottle of antiinflammatory ophthalmic products for 

use in both eyes for post-surgical 

indications as it relates to the potential 

risk for infection. The FDA’s Center for 

Drug Evaluation and Research would 

like the advisory committee to provide 

advice on the potential risk and 

approaches to mitigating that risk, 

including limits to fill size where 

appropriate. 

On page 71349, in the third column, 

the third sentence in the Procedure 

portion of the document is changed to 

read as follows: 

Procedure: Oral presentations from 

the public will be scheduled between 

approximately 11:30 a.m. and 12:30 

p.m. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: February 8, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–3343 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of Antimesothelin Targeted Immunotoxins for 

the Treatment of Cancer 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

Part 404.7(a)(1)(i), that 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 US Patent application 61/ 

535,668 entitled ‘‘Pseudomonas 

Exotoxin A with Less Immunogenic B 

Cell Epitopes’’ [HHS Ref. E–263–2011/ 

0–US–01], US Patent application 61/ 

495,085 entitled ‘‘Pseudomonas 

Exotoxin A with Less Immunogenic T 

Cell Epitopes’’ [HHS Ref. E–174–2011/ 

0–US–01], US Patent application 61/ 

483,531 entitled ‘‘Recombinant 

Immunotoxin Targeting Mesothelin’’ 

[HHS Ref. E–117–2011/0–US–01], U.S. 

Patent Application 61/241,620 entitled 

‘‘Development of an Immunotoxin in 

Which All B–Cell Epitopes Have Been 

Removed and Which Has High 

Cytotoxic Activity’’ [HHS Ref. E–269– 

2009/0–US–01], U.S. Patent Application 

60/969,929 entitled ‘‘Deletions in 

Domain II of Pseudomonas Exotoxin A 

That Reduce Non-Specific Toxicity’’ 

[HHS Ref. E–292–2007/0–US–01], U.S. 

Patent Application 60/703,798 entitled 

‘‘Mutated Pseudomonas Exotoxins with 

Reduced Antigenicity’’ [HHS Ref. E– 

262–2005/0–US–01], U.S. Patent 

Application 60/160,071 entitled 

‘‘Immunoconjugates Having High 

Binding Affinity’’ [HHS Ref. E–139– 

1999/0–US–01], U.S. Patent Application 

60/067,175 entitled ‘‘Antibodies, 

Including Fv Molecules, and 

Immunoconjugates Having High 

Binding Affinity for Mesothelin and 

Methods for Their Use’’ [HHS Ref. E– 

021–1998/0–US–01], U.S. Patent 

Application 60/010,166 entitled 

‘‘Molecular Cloning of Mesothelin, a 

Differentiation Antigen Present on 

Mesothelium, Mesotheliomas and 

Ovarian Cancers’’ [HHS Ref. E–002– 

1996/0–US–01], PCT Application PCT/ 

US97/00224 entitled ‘‘Mesothelin 

Antigen and Methods and Kits for 

Targeting It’’ [HHS Ref. E–002–1996/1– 

PCT–01], U.S. Patent 5,747,654 entitled 

‘‘Recombinant Disulfide-Stabilized 

Polypeptide Fragments Having Binding 

Specificity’’ [HHS Ref. E–163–1993/0– 

US–01], PCT application PCT/US96/ 

16327 entitled ‘‘Immunotoxin 

Containing A Disulfide-Stabilized 

Antibody Fragment’’ [HHS Ref. E–163– 

1993/2–PCT–01], and all continuing 

applications and foreign counterparts, to 

Hoffman-La Roche, Inc. The patent 

rights in these inventions have been 

assigned to and/or exclusively licensed 

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 use of anti-mesothelin targeted 

immunotoxins for the treatment of 

mesothelin-expressing cancers, wherein the 

immunotoxins have: (1) A targeting domain 

containing the complementary determining 

regions (CDR) of the SS1 antibody and (2) a 

Pseudomonas exotoxin A (‘‘PE’’) toxin 

domain that is (a) lysosomal protease 

resistant (PE–LR) and (b) lacks at least one 

major B-cell epitope due to the alteration of 

an amino acid. The immunotoxin may 

include additional alterations to B-cell and Tcell epitopes for reduction of 

immunogenicity, as well as a peptide linker 

sequence. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before March 

15, 2012 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: David A. Lambertson, 

PhD, Senior Licensing and Patenting 

Manager, Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–4632; Facsimile: (301) 402– 

0220; Email: lambertsond@od.nih.gov. 

SUPPLEMENTARY INFORMATION: These 

inventions concern immunotoxins 

which are targeted to mesothelinexpressing cancer cells, and methods of 

mstockstill on DSK4VPTVN1PROD with NOTICES

8264 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 

using the immunotoxins for the 

treatment of mesothelin-expressing 

cancers (such as mesothelioma, ovarian 

cancer and pancreatic cancer). The 

specific immunotoxin will have an 

antibody targeting domain that contains 

the CDRs of the antibody identified as 

SS1, which was invented at the NIH. 

The specific immunotoxin will also 

have a toxin domain derived from PE 

that is resistant to lysosomal proteases 

due to the deletion of a large portion of 

the exotoxin, and which lacks at least 

one major B-cell epitope due to the 

alteration an amino acid. Ultimately, the 

PE used in the immunotoxin may lack 

multiple B-cell epitopes, as well as 

multiple T-cell epitopes, in an effort to 

minimize immunogenicity. 

Alterations to the toxin that reduce 

immunogenicity improve the 

therapeutic value of the immunotoxin 

while maintaining its ability to trigger 

cell death. Since mesothelin is 

preferentially expressed on certain types 

of cancer cells, the immunotoxins 

selectively bind and kill only those 

cancer cells, allowing healthy, essential 

cells to remain unharmed. This results 

in an effective therapeutic strategy with 

fewer side effects. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR Part 404.7. The 

prospective exclusive license may be 

granted unless the NIH 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 404.7 

within thirty (30) days from the date of 

this published notice. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

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: February 8, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

& Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–3410 Filed 2–13–12; 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, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 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. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Encapsulated N–Acetylmannosamine or 

N–Acetylneuraminic Acid as a 

Therapeutic Agent for Increasing 

Sialylation in Certain Muscular 

Atrophies, Kidney Disorders, Cancers 

or Poor Immune Function 

Description of Technology: Nacetylmannosamine is a precursor for 

the synthesis of sugar molecules known 

as sialic acids, which play an important 

role in specific biological processes 

such as cellular adhesion, cellular 

communication and signal transduction. 

Lack of sialic acids also plays a crucial 

role in disease processes such as 

inflammation, immune responses, as 

well as certain muscular atrophies 

(including hereditary inclusion body 

myopathy (HIBM) and distal myopathy 

with rimmed vacuoles (DMRV or 

Nonaka myopathy)), certain kidney 

disorders with proteinuria and 

hematuria (including minimal change 

nephrosis and focal segmental 

glomerulosclerosis), and certain cancers 

(including bladder cancer and myeloid 

leukemia). 

This technology relates to methods of 

administering liposome-encapsulated Nacetylmannosamine, Nacetylneuraminic acid, or their 

derivatives to treat human disorders of 

hyposialylation (by increasing sialic 

acid production in patients who are 

deficient in that sugar molecule). 

Liposome-encapsulated delivery of 

these monosaccharides enhances 

successful systemic delivery, including 

to the central nervous system (crossing 

the blood-brain barrier), and liposome 

encapsulation protects against 

gastrointestinal tract degradation. 

Potential Commercial Applications: 

• Treatment of rare diseases such as 

HIBM and Nonaka myopathy (or 

DMRV). 

• Treatment of kidney conditions 

involving sialic acid deficiencies, 

resulting in proteinuria and hematuria. 

• Treatment of other diseases 

involving sialic acid deficiencies. 

• Use as immune stimulant since 

adequate sialic acid is important for 

robust immune function. 

Competitive Advantages: 

• N-acetylmannosamine is the only 

uncharged sugar in the sialic acid 

biosynthesis pathway (thus making it 

easier to deliver than charged sugars) 

and is located after the rate-limiting 

step. 

• N-acetyl mannosamine and Nacetylneuraminic acid have been shown 

to rescue hyposialylation in mouse 

models of HIBM. 

• Encapsulated Nacetylmannosamine or Nacetylneuraminic acid crosses the 

blood-brain barrier and prevents 

gastrointestinal tract degradation more 

efficiently than unencapsulated drug. 

Development Stage: 

• Pre-clinical 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Marjan Huizing et al. 

(NHGRI). 

Publications: 

1. Galeano B, et al. Mutation in the 

key enzyme of sialic acid biosynthesis 

causes severe glomerular proteinuria 

and is rescued by Nacetylmannosamine. J Clin Invest. 2007 

Jun;117(6):1585–1594. [PMID 17549255] 

2. Nemunaitis G, et al. Hereditary 

inclusion body myopathy: single patient 

response to intravenous dosing of GNE 

gene lipoplex. Hum Gene Ther. 2011 

Nov;22(11):1331–1341. [PMID 

21517694] 

3. Kakani S, et al. The Gne M712T 

mouse as a model for human 

glomerulopathy. Am J Pathol., in press 

(Dec 2011) (available online in Feb 

2012) 

Intellectual Property: HHS Reference 

No. E–270–2011/0 — U.S. Application 

No. 61/531,934 filed 07 Sep 2011. 

Licensing Contact: Tara L. Kirby, 

Ph.D.; 301–435–4426; 

tarak@mail.nih.gov. 

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