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Tetravalent bispecific fusion antibody for immunotherapy

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
70508
Program Year/Program:
2004 / SBIR
Agency Tracking Number:
CA110297
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
IMMUNOMEDICS, INC.
300 The American Road Morris Plains, NJ 07950-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2004
Title: Tetravalent bispecific fusion antibody for immunotherapy
Agency: HHS
Contract: 1R43CA110297-01
Award Amount: $134,285.00
 

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.

Principal Investigator:

Zhengxing Qu
9736058200
TQU@IMMUNOMEDICS.COM

Business Contact:

Cynthia Sullivan
9735409595
CSULLIVAN@IMMUNOMEDICS.COM
Small Business Information at Submission:

IMMUNOMEDICS, INC.
IMMUNOMEDICS, INC. 300 AMERICAN RD MORRIS PLAINS, NJ 07950

EIN/Tax ID: 611009366
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No