Targeting B-cell lymphoma with Leukothera

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$202,601.00
Award Year:
2012
Program:
STTR
Phase:
Phase I
Contract:
1R41CA173900-01
Award Id:
n/a
Agency Tracking Number:
R41CA173900
Solicitation Year:
2012
Solicitation Topic Code:
NCI
Solicitation Number:
PA12-088
Small Business Information
675 US HIGHWAY 1, NORTH BRUNSWICK, NJ, 08902-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
829616676
Principal Investigator:
BENJAMIN BELINKA
(732) 371-2694
benbelinka@actinobac.com
Business Contact:
BENJAMIN BELINKA
(732) 371-2694
benbelinka@actinobac.com
Research Institution:
CANCER INSTITUTE OF NEW JERSEY

CANCER INSTITUTE OF NEW JERSEY
195 LITTLE ALBANY ST
NEW BRUNSWICK, NJ, 08903-1914
() -
Domestic nonprofit research organization
Abstract
DESCRIPTION (provided by applicant): B-cell lymphomas include Hodgkin's, and non-Hodgkin's lymphoma (NHL) (eg. mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and Burkitt lymphoma). More than 70,000 people willbe diagnosed with these B-cell malignancies in the U.S. this year and more than 19,000 will die from NHL alone. B-cell lymphomas can affect numerous organs including the lymph nodes, spleen, liver, and bone marrow. Many patients who receive treatment for B-cell lymphomas become refractory to all available therapies and often die from disease. Thus, there is a significant need to identify newer therapeutics with greater activity and fewer side effects. The novel biologic agent Leukothera(R) (leukotoxin; LtxA) specifically targets active leukocyte function antigen-1 (LFA-1) expressed on white blood cells (WBCs). Malignant WBCs constantly express high levels active LFA-1, allowing LtxA to target specifically diseased cells while minimally affecting healthy cells and tissue. LtxA employs several mechanisms of cell death to intoxicate susceptible WBCs. We have found that cell lines and primary cells from patients with newly diagnosed, relapsed, and refractory leukemia and lymphoma are highly sensitive to LtxA. Inpreclinical studies, LtxA shows significant efficacy using humanized mouse models for leukemia. In addition, single- dose LtxA administered intravenously into rhesus monkeys was active, highly specific for WBCs, and well-tolerated. No effect was seen on red blood cells, platelets, hemoglobin, or markers of organ toxicity. However, no studies have yet examined LtxA for the treatment of B- cell lymphoma. Thus, based on our encouraging preclinical studies for leukemia, we propose to test LtxA using in vitro and in vivo B-cell lymphoma model systems. The data that we generate from the work described in this application is necessary to provide proof-of-principle and mechanistic knowledge for subsequent clinical testing in lymphoma patients. PUBLIC HEALTHRELEVANCE: B-cell lymphomas kill thousands of people each year. We are developing a biotherapeutic agent (leukotoxin) that has targeted specificity for malignant white blood cells. Our studies will test the hypothesis that leukotoxin can be used for the treatment of B-cell lymphomas employing in vitro and in vivo models.

* information listed above is at the time of submission.

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