TC-99M-F(AB)2 Instant Kits for Radioimmunoscintigraphy

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$50,000.00
Award Year:
1993
Program:
SBIR
Phase:
Phase I
Contract:
n/a
Award Id:
22297
Agency Tracking Number:
22297
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
300 American Road, Morris Plains, NJ, 07950
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Gary L. Griffiths
(201) 605-8200
Business Contact:
() -
Research Institute:
n/a
Abstract
The goal is to develop the optimum clinical agent for radioimmunoscintigraphy. The optimum nuclide is undoubtedly technetium- 99m. Comparing IgG-SH, F(ab')2-SH and Fab'-SH, it is expected that a F(ab')2-SH fragment will have fast enough clearance from circulation to permit earlier imaging than a comparably radiolabeled IgG-SH, while having less renal uptake than a comparably labeled Fab'-SH fragment. Previously, direct labeling of F(ab')2-SH was problematic in that a 50:50 mixture of Tc-99m-F(ab')2 and Tc99m-Fab' would result due to the presence of a small amount of monovalent fragment. We have a novel technique of pre.reducing intact IgG to break non-hinge region disulfide bonds prior to digestion of antibody. The resulting, pure F(ab')2-SH is capable of quantitative incorporation of technetium-99m, in the same manner as IgG-SH and Fab'-SH, are currently labeled to yield quantitatively Tc-99m-F(ab')2. We will extend the technique to different antibodies targeted against different cancers, and ultimately use humanized F(ab')2-SH fragments. In phase l research, we will prove the superiority of Tc99m-F(ab')2 over Tc-99m- Fab' and Tc-99m-IgG as an early time-point radioimmunoimaging agent; if successful, produce clinically usable kits at the conclusion of the Phase II period.

* information listed above is at the time of submission.

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