Packaging Cell Lines for Lentiviral Vector Products

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$198,889.00
Award Year:
2010
Program:
STTR
Phase:
Phase I
Contract:
1R41RR032111-01A1
Agency Tracking Number:
R41RR032111
Solicitation Year:
2010
Solicitation Topic Code:
NCRR
Solicitation Number:
PA09-114
Small Business Information
RIMEDION, INC.
351 W 10TH ST, STE 514, INDIANAPOLIS, IN, 46202-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
828836614
Principal Investigator:
KENNETH CORNETTA
(317) 278-0501
kcornetta@iupui.edu
Business Contact:
BUTCH MERCER
(317) 637-9000
butchmercer@rimedion.com
Research Institution:
Indiana University

601 E KIRKWOOD AVE
BLOOMINGTON, IN, 47405-1223
() -
Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): HIV-1 based lentiviral vectors are becoming an increasingly attractive means of integrating transgenes into target cells. Vectors are in or enterning clinical trials for a diverse group of ailments, including genetic disease, AIDS and cancer. To expand the range of target cells beyond that of HIV-1 (CD4+ cells), vectors are pseudotyped with various viral envelopes. Rimedion has identified the Ross River Virus (RRV) and the feline RD114 envelope glycoproteins to be promising candidates for production of stable packaging cell lines. In this STTR application, Rimedion and its research partner, Indiana University School of Medicine proposes to develop novel, stable lentiviral packaging cell lines using these envelope. These lines will be useful for further preclinical development and will also be suitable for future clinical use. Specific Aim 1: Rimedion will generate stable packaging lines expressing the RRV and RD114 envelopes. Specific Aim 2: Using the packaging cell linesfor RRV and RD114, generate stable lentiviral producer cell lines expressing the Green Fluorescent Protein to be used for studies of vector titer, long-term cell line stability and replication competent lentiviral testing. These cell lines will replace thecurrent manufacutring methodolgy (transient transfection) for lentiviral vectors which is not suitable for large scale productions and limits the potential of lentiviral vectors from achieving licensure by the FDA. If successful, these cell lines will provide the platform technology for a large group of new biologic agents. Phase II will include the certification to meet FDA Guidances so the lines may be used in Good Manufacturing Practices. As part of Phase II, the RD114 cell line would be used to createa producer cell line for treatment of adenosine deaminase deficieny in a Phase I clinical trial. Through appropriate material agreements, the lines will also be made available to academic investigators for investigational, non-commerical use through NIH sponsored programs such as the National Gene Vector Biorepostory. PUBLIC HEALTH RELEVANCE: Gene therapy mediated by lentiviral vectors is now in clinical trials and holds promise for a wide variety of genetic diseases, AIDS and cancer. A major limitation to commercialization of these biologic products is large- scale production technology. Rimedion proposes to generate a series of lentiviral packaging cell lines that will allow manufacturing of lentiviral products suitable for FDA licensure specifications.

* information listed above is at the time of submission.

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