In Phase I of this SBIR, ImmPORT Therapeutics and the UCI Proteomics Core developed a high throughput gene cloning and protein expression platform that allowed the proteomes of any sequenced infectious agent to be expressed and printed onto microarray chips. Since Phase I we have cloned and expressed ~15,000 genes from nearly 20 different pathogens associated with biodefense and emerging infectious diseases. By probing the arrays with sera from individuals with well-defined clinical stages of infection, we have built up a vast dataset concerning which antibodies are present in different stages of disease. By using statistical and bioinformatic algorithms, we can derive antigen sets that, when combined, can provide the basis for serological tests able to discriminate between different infections, or even between different stages of the same infection. Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and services to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be serodiagnostic immunostrips that will be evaluated for discriminating orthopoxvirus infections from clinically similar rash infections and for diagnosing TORCH infections associated with problems during pregnancy.
Aim 1 : Clone an additional 2000 genes from various rash causing organisms and combine these with an existing inventory of orthopoxvirus and herpes viruses. These will printed on arrays and, in collaboration with colleagues at the CDC, arrays will be probed with well characterized sera to define immunodominant and serodiagnostic antigens. From these data we will produce prototype immunostrips for manufacture and evaluation at CDC.
Aim 2 : Establish a GMP protein purification and diagnostic reagent manufacturing facility at ImmPORT. The facility will manufacture protein arrays and immunostrips for its Clinical Research Laboratory , and assay kits that will be sold to biomedical research labs and reference laboratories, and as a pivotal FDA-required assay to support licensure of clinical products.
Aim 3. Establish a Clinical Research Laboratory at ImmPORT to offer serodiagnostic testing services that will operate in compliance with the Clinical Laboratory Improvement Amendment (CLIA) to be certified to perform validated testing on human specimens for diagnosis, and to provide FDA compliant test results to support licensure of clinical products. With the establishment of a manufacturing infrastructure at ImmPORT, the company's high throughput antigen discovery platform will continue to rapidly identify candidate antigens for development of other serodiagnostics and subunit vaccine products for category A, B and C biological agents and well as other emerging infectious diseases of importance to human health. Project Narrative With support from a phase I SBIR, ImmPORT Therapeutics and the Proteomics Core Lab UCI developed a method for screening the whole proteomes of infectious organisms for diagnostic and vaccine antigens. In Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and services to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be serodiagnostic immunostrips that will be evaluated for discriminating orthopoxvirus infections from clinically similar rash infections and for diagnosing TORCH infections associated with problems during pregnancy.

Public Health Relevance

With support from a phase I SBIR, ImmPORT Therapeutics and the Proteomics Core Lab UCI developed a method for screening the whole proteomes of infectious organisms for diagnostic and vaccine antigens. In Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and services to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be serodiagnostic immunostrips that will be evaluated for discriminating orthopoxvirus infections from clinically similar rash infections and for diagnosing TORCH infections associated with problems during pregnancy.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI058365-05
Application #
7883475
Study Section
Special Emphasis Panel (ZRG1-IDM-M (12))
Program Officer
Challberg, Mark D
Project Start
2004-06-15
Project End
2012-06-30
Budget Start
2010-07-01
Budget End
2012-06-30
Support Year
5
Fiscal Year
2010
Total Cost
$991,855
Indirect Cost
Name
Immport Therapeutics, Inc.
Department
Type
DUNS #
159838106
City
Irvine
State
CA
Country
United States
Zip Code
92618
Dö?kaya, Mert; Liang, Li; Jain, Aarti et al. (2018) Discovery of new Toxoplasma gondii antigenic proteins using a high throughput protein microarray approach screening sera of murine model infected orally with oocysts and tissue cysts. Parasit Vectors 11:393
Nayak, Kaustuv; Jing, Lichen; Russell, Ronnie M et al. (2015) Identification of novel Mycobacterium tuberculosis CD4 T-cell antigens via high throughput proteome screening. Tuberculosis (Edinb) 95:275-87
Felgner, Jiin; Juarez, Silvia; Hung, Chris et al. (2015) Identification of Toxoplasma gondii antigens associated with different types of infection by serum antibody profiling. Parasitology 142:827-38
Davies, D Huw; Duffy, Patrick; Bodmer, Jean-Luc et al. (2015) Large screen approaches to identify novel malaria vaccine candidates. Vaccine 33:7496-505
Davies, D Huw; Chun, Sookhee; Hermanson, Gary et al. (2014) T cell antigen discovery using soluble vaccinia proteome reveals recognition of antigens with both virion and nonvirion association. J Immunol 193:1812-27
Felgner, Philip L; Roestenberg, Meta; Liang, Li et al. (2013) Pre-erythrocytic antibody profiles induced by controlled human malaria infections in healthy volunteers under chloroquine prophylaxis. Sci Rep 3:3549
Jing, Lichen; Schiffer, Joshua T; Chong, Tiana M et al. (2013) CD4 T-cell memory responses to viral infections of humans show pronounced immunodominance independent of duration or viral persistence. J Virol 87:2617-27
Dasgupta, Gargi; Chentoufi, Aziz A; Kalantari, Mina et al. (2012) Immunodominant ""asymptomatic"" herpes simplex virus 1 and 2 protein antigens identified by probing whole-ORFome microarrays with serum antibodies from seropositive asymptomatic versus symptomatic individuals. J Virol 86:4358-69
Hermanson, Gary; Chun, Sookhee; Felgner, Jiin et al. (2012) Measurement of antibody responses to Modified Vaccinia virus Ankara (MVA) and Dryvax(®) using proteome microarrays and development of recombinant protein ELISAs. Vaccine 30:614-25
Tan, Xiaolin; Chun, Sookhee; Pablo, Jozelyn et al. (2012) Failure of the smallpox vaccine to develop a skin lesion in vaccinia virus-naïve individuals is related to differences in antibody profiles before vaccination, not after. Clin Vaccine Immunol 19:418-28

Showing the most recent 10 out of 13 publications