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Development of GIFT4: a B cell focused immunotherapy for cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA217365-01
Agency Tracking Number: R44CA217365
Amount: $1,999,085.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PAR14-088
Timeline
Solicitation Year: 2014
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-05-12
Award End Date (Contract End Date): 2020-04-30
Small Business Information
16 CAVENDISH CT
Lebanon, NH 03766-1441
United States
DUNS: 828763263
HUBZone Owned: Yes
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PAUL GUYRE
 (617) 320-8521
 pg@celdaramedical.com
Business Contact
 JAKE REDER
Phone: (617) 320-8521
Email: jr@celdaramedical.com
Research Institution
N/A
Abstract

Project Summary
Our goal is to develop a novel immunotherapy for the treatment of melanomaand potentially a wide array of
tumorsAlthough surveillance by the immune system eliminates cancer cells in some instancestumor cells
have developed a variety of mechanisms to escape immune recognition often resulting in tumor outgrowthImmune checkpoint inhibitorse gipilimumabnivolumaband pembrolizumaband cellular immunotherapiese gadoptive cell transfer and CARchimeric antigen receptorT cellsare showing dramatic efficacy in ongoing clinical trialsHowevereven the most promising therapies are effective for a limited range of cancers
and only for a minority of patientse gresponse rates with PDinhibitors areMoreoverthey can
be associated with significant toxicitiesand tumorsespecially solid tumorseventually develop resistanceThe potential of B cells as anti tumor immunotherapeutics hasto a large extentremained untappedNeverthelessB cells constitute part of the cancer infiltrating immune cells and they have anti tumor properties
including production of tumor suppressive cytokines and enhancing tumor killing T cell responseIndeedthe
presence of B cells in the tumor microenvironment is correlated with long term survival for cancer patientsThis application is focused on advancing our preclinical development in preparation for a subsequent
Investigational New DrugINDapplication to the FDAWe will determine the optimal efficacious dose of
GIFTin murine models of cancerassemble a toxicology package in appropriate models and optimize
exprssion and develop fermentation and large scale purification protocolsSuccessful commercialization would
ultimately provide profound anti tumor immunotherapeutic benefits in a wide variety of cancer indicationsparticularly those characterized by a weakened immune system that do not respond to other immunotherapies

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

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