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Novel Immuno-oncology Strategy for Targeted Cytotoxic Lymphocyte Activation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA224520-01A1
Agency Tracking Number: R41CA224520
Amount: $288,105.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Houston, TX 77046-0117
United States
DUNS: 080179614
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (434) 924-8016
Business Contact
Phone: (713) 898-0838
Research Institution
HOUSTON, TX 77098-3738
United States

 Domestic Nonprofit Research Organization

Systemic administration of high dose ILhas been used since thes as an FDA approved
immunotherapy for metastatic cancerDespite the fact that up toof patients treated with high dose ILachieve a durablelong term responsethis therapy is rarely used today due to significant life threatening
complicationsSuch complications occur due to ILactivation of vascular endotheliumresulting in systemic
capillary leakas well as other adverse effects associated withoff targetsignaling of ILIn additionILpreferentially activates CDFoxpregulatory T cells that mitigate the tumor specific responseWe recently
published an ILfusion protein which targets and solely activates cytotoxic T lymphocytes in the absence of
endothelial or regulatory T cell activationIn addition to a dramatically increased safety profileour ILfusion
protein inhibits the growth of highly aggressive tumors normally resistant to other forms of immunotherapyThe
purpose of the current proposal is to evaluate the immunogenicity of this proteinexplore its clinical response
when used in combination with checkpoint blockade immunotherapyand evaluate its utility for expansion of
tumor reactive leukocytes for adoptive cell therapySuccessful completion of the proposed studies will support
a Phase II STTR application and eventually advancement of this therapy to IND enabling studiesOur ultimate
goal is to submit this novel immunotherapy to the FDA for first in human clinical safety trials PROJECT NARRATIVE
Patients with advanced cancerssuch as lung cancerhave few treatment options with limited long term
survivalFDA approved high dose ILtherapy leads to a high rate of long term durable remissions in several
malignanciesbut is infrequently utilized due to high rates of therapy associated morbidity and mortalityCourier Therapeutics has developed a targeted form of ILwhich dramatically reduces the adverse effects of
ILtherapy while enhancing therapeutic efficacyThese studies will support future submission of this novel
therapeutic agent to the FDA for a lung cancer human clinical trial

* Information listed above is at the time of submission. *

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