Tetravalent bispecific fusion antibody for immunotherapy

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$134,285.00
Award Year:
2004
Program:
SBIR
Phase:
Phase I
Contract:
1R43CA110297-01
Award Id:
70508
Agency Tracking Number:
CA110297
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
IMMUNOMEDICS, INC., 300 AMERICAN RD, MORRIS PLAINS, NJ, 07950
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
ZHENGXING QU
(973) 605-8200
TQU@IMMUNOMEDICS.COM
Business Contact:
CYNTHIA SULLIVAN
(973) 540-9595
CSULLIVAN@IMMUNOMEDICS.COM
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Immunotherapy based on a naked monoclonal antibody (mAb), such as rituximab, has emerged as a safe and effective modality for treatment of indolent and aggressive non-Hodgkin's lymphomas (NHL) and chronic lymphocytic leukemias (CLL). Almost half of the patients with indolent lymphomas failed to respond to initial treatment with rituximab. To improve the therapeutic effectiveness, combination therapy with two mAbs against distinct antigens on B-lymphocytes is under active investigation, providing encouraging results in yet small pilot clinical trials. The objectives of this SBIR investigation is to develop a tetravalent bispecific fusion protein derived from two different humanized antibodies against human CD22 and CD20, and to explore the potentials of utilizing this tetravalent bispecific antibody (bsAb) as a "single agent" for treatment of patients with B-cell neoplastia to further improve the efficacy, safety, and convenience of the combination therapy. In Phase I, the fusion bsAb will be engineered by recombinant technology and expressed in a mammalian cell line, and high-level bsAb-producing clones suitable for industrial scale production will be developed. In this preliminary stage of a new drug development, the physical, biochemical, and immunological properties of the recombinant bsAb will be thoroughly characterized. In addition, in vitro and in vivo characteristics of the bsAb against neoplastic B-cells will be evaluated. Phase II will focus on detailed preclinical studies including biodistribution, pharmacokinetic and tumor therapy in animals. The ultimate goal of the Phase II application is to develop a cell line that is optimized for production in bioreactors so that clinical grade material insufficient quantities can be obtained for clinical studies.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government