CBT Supervisor's Toolkit: Phase II

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$200,782.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1R43CA180343-01
Agency Tracking Number:
R43CA180343
Solicitation Year:
2013
Solicitation Topic Code:
NCI
Solicitation Number:
PA12-088
Small Business Information
IMMUNOMEDICS, INC.
300 The American Road, Morris Plains, NJ, 07950-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
115350605
Principal Investigator:
DONGLIN LIU
(973) 605-8200
dliu@immunomedics.com
Business Contact:
CHAU CHENG
(973) 605-8200
ccheng@immunomedics.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Triple-negative breast cancer (TNBC) is a subset of breast cancers with poor prognosis and high mortality due to the lack of effective therapeutic regimens. This Phase I SBIR application is to develop E1-Rap, a novel immunoRNases, for treating TNBC. E1-Rap is a DOCK-AND-LOCKTM (DNLTM) complex, comprising four copies of ranpirnase (Rap) site-specifically tethered to the CH3-terminus of hRS7, a humanized monoclonal antibody targeting TROP-2, a transmembrane protein over-expressed in diverse epithelial cancers. We have shown that TROP-2 is present on the surface of TNBC cells, and targeted delivery of E1-Rap significantly enhances the binding, internalization, and cytotoxicity of Rap in TROP-2-positive cell lines. More importantly, E1-Rap has greatly improved the potency over the previously made fusion protein (Rap-hRS7), but maintained minimal toxicity to TROP-2-negative cell lines and human PBMC. In this Phase I application, we will scale up the production of E1-Rap and evaluate the in vivo properties of E1-Rap, including PK, stability, safety, bioavailability, and the therapeutic activity of E1-Rap in human TNBC xenograft models. Successful accomplishments of these Phase I goals will lead to a Phase II application aimed tocomplete the preclinical development of E1-Rap for clinical trials. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This project will investigate the pharmacokinetics, safety, and bioavailability of E1-Rap, a DOCK-AND-LOCKTM complex of ranpirnase and hRS7 targeting TROP-2-positive epithelial cancers, in particular, triple-negative breast cancer (TNBC), and determine the therapeutic activity of E1-Rap in human TNBC xenograft models.

* information listed above is at the time of submission.

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