37030 Federal Register / Vol. 72, No. 129 / Friday, July 6, 2007 / Notices 

Modification of Recombinant AntiTumor RNase (rapLR1) for Optimal Use 

in the Large Scale Manufacture of 

Stable and Potent RapLR1-Antibody 

Conjugates 

Description of Technology: This 

technology involves modified rapLR1 

molecules having an improved capacity 

for conjugation to targeting moieties. 

Previously, techniques for attaching 

wild-type rapLR1 to a targeting moiety 

required an excess of RNase, leading to 

high production costs. The inventors 

have now mutated specific amino acids 

in rapLR1 to allow a more efficient (and 

therefore less costly) conjugation 

reaction. 

Members of the ribonuclease A 

(RNase A) superfamily, such as rapLR1, 

have the ability to efficiently kill a wide 

range of cancer cells. Ligand binding 

moieties such as antibodies or peptides 

can be used to target RNases to a 

particular cell or cell type that expresses 

a marker, e.g., a marker that is 

associated with cancer. The current 

invention provides rapLR1 molecules 

that have been genetically modified to 

contain a cysteine at a specific location 

that does not interfere with the 

enzymatic activity of the molecule. The 

inserted cysteine provides the advantage 

of a site-directed and specific 

attachment of rapLR1 to targeting 

moieties, which results in more efficient 

production of the therapeutic. This 

significantly reduces the cost of bringing 

rapLR1-related cancer therapeutics to 

market. 

Applications: Targeted anti-cancer 

therapy molecules; Targeting moiety can 

be interchanged based on target cancer 

cells; Targeting any disease in which the 

cell is transformed and presents unique 

levels of cell surface markers. 

Advantages: RapLR1 delivery, 

specificity and toxicity to cancer cells is 

increased by conjugation to a targeting 

moiety; Modified rapLR1 increases 

conjugation efficiency, making the 

preparation of the anti-cancer agents 

more cost effective without sacrificing 

specificity. 

Benefits: Cancer is the second leading 

cause of death in the United States, with 

approximately 600,000 cancer-related 

deaths occurring in 2006 alone. Because 

rapLR1 can be used to treat a number of 

different cancers (depending on the 

targeting moiety), there is a powerful 

social benefit from this technology: 

Improving the duration and quality of 

life of a wide range of cancer patients. 

Furthermore, the cancer therapeutic 

market is expected to reach $27 billion 

by 2009. Because rapLR1 can now be 

efficiently conjugated to targeting 

moieties, there is an opportunity to 

occupy a significant niche in that 

predicted market, with lower cost to the 

licensee. 

Inventors: Dianne L. Newton et al. 

(NCI). 

U.S. Patent Status: Pending PCT 

Application PCT/US2006/038180, 

published as WO 2007/041361 (HHS 

Reference No. E–265–2005/0–PCT–02). 

Licensing Contact: David A. 

Lambertson, PhD; Phone: (301) 435–

4632; Fax: (301) 402–0220; E-mail: 

lambertsond@mail.nih.gov. 

Methods for Expression and 

Purification of Immunotoxins 

Description of Technology: The 

invention concerns immunotoxins and 

methods of making the immunotoxins. 

Targeting of the immunotoxins occurs 

via an antibody that is specific to T 

cells. This allows the specific ablation 

of malignant T cells and resting T cells. 

The transient ablation of resting T cells 

can ‘‘reset’’ the immune system by 

accentuating tolerizing responses. As a 

result, the immunotoxin can be used to 

treat autoimmune disease, malignant T 

cell-related cancers, and graft-versushost disease. The toxin portion of the 

immunotoxin is engineered to maintain 

bioactivity when produced in yeast, 

specifically Pichia pastoris. This system 

allows the production of dimeric 

antibody fragments with increased 

binding affinity and potency. 

Applications: Immunotoxins 

produced by this method can be used 

for the treatment of autoimmune 

diseases such as multiple sclerosis, 

lupus, type I diabetes, aplastic anemia; 

Immunotoxins produced by this method 

can be used for treatment of T-cell 

leukemias and lymphomas such as 

cutaneous T cell leukemia/lymphoma 

(CTCL); Immunotoxins produced by this 

method can be used for increasing 

immune tolerance in patients requiring 

transplants/grafts. 

Advantages: Method produces GMP 

quality immunotoxin and can be scaled 

up to industry scales; Modified toxin 

moiety has reduced glycosylation in this 

system, resulting in a more effective and 

efficient immunotoxin; Immunotoxin 

doesn’t produce the deleterious sideeffects seen with other methods of 

treating autoimmune disease, malignant 

T cell leukemia/lymphoma and graftversus-host disease. 

Benefits: New methods and 

compositions with limited side-effects 

have the potential to revolutionize 

treatment of autoimmune disease; 

provides an opportunity to capture a 

significant market share for the millions 

of people who suffer from an 

autoimmune disease. 

Inventors: David Neville et al. (NIMH) 

Patent Status: U.S. Patent Application 

No. 10/566,886 filed 01 Feb 2006, which 

published as U.S. 2006/0216782 on 28 

Sep 2006 (HHS Reference No. E–043–

1997/2–US–03); U.S. Patent No. 

6,632,928 issued 14 Oct 2003 (HHS 

Reference No. E–044–1997/0–US–07); 

U.S. Patent Application No. 10/435,567 

filed 09 May 2003, which published as 

2003/0185825 on 02 Oct 2003 (HHS 

Reference No. E–044–1997/0–US–08); 

U.S. Patent Application No. 10/296,085 

filed 18 Nov 2002, which published as 

2004/0127682 on 01 Jul 2004 (HHS 

Reference No. E–044–1997/1–US–06); 

Foreign rights are also available. 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: David A. 

Lambertson, PhD; 301/435–4632; 

lambertsond@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Mental Health, 

Laboratory of Molecular Biology, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

methods of expression and purification 

of immunotoxins. Please contact David 

Neville at davidn@mail.nih.gov for more 

information. 

Dated: June 28, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–13128 Filed 7–5–07; 8:45 am] 

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Federal Register / Vol. 72, No. 129 / Friday, July 6, 2007 / Notices 37031 

Name of Committee: National Institutes of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Texas–SNRP. 

Date: July 16–17, 2007. 

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HHS) 

Dated: June 29, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–3292 Filed 7–5–07; 8:45 am] 

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Anna Snouffer, 

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[FR Doc. 07–3295 Filed 7–05–07; 8:45 am] 

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