IRVINE, CA, United States

Immport Therapeutics, Inc.

www.antigendiscovery.com
IRVINE, CA, United States
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Patent
Immport Therapeutics, Inc. | Date: 2016-10-04

Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.


Patent
Immport Therapeutics, Inc. | Date: 2014-10-12

Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.


Contemplated compositions, devices, and methods are drawn to various antigens from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.


Patent
Immport Therapeutics, Inc. | Date: 2014-10-20

Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.34M | Year: 2012

DESCRIPTION (provided by applicant): For the Phase I SBIR grant we constructed a Plasmodium falciparum (Pf) 3D7 protein microarray containing 2,320 individual polypeptides representing 1,200 known and hypothetical proteins, or ~23 % of the entire Pf proteome. We showed that the individual proteins printed on those arrays captured antibodies present in sera from infected individuals and the amount of captured antibody could be quantified using fluorescent secondary antibody. In this way, the complete profileof antibodies that results after natural or experimental exposure or immunization can be determined. We probed the array with serum from people residing in Mali and identified a panel of potential vaccine antigen candidates against which antibodies were significantly elevated in protected children compared to age-matched susceptible children from the same village. In another study, we described a panel of biomarkers and potential vaccine antigens that were preferentially recognized in sera of protected volunteers immunized by the bite of irradiated Pf sporozoites infected mosquitoes as compared to similarly vaccinated but unprotected subjects. These results validate the utility of the Pf proteome microarray developed in the Phase I grant to identify antibodies associated with immune protection. In this Phase II application, we propose to apply an expanded version of the proteome microarray developed in Phase I (containing 4,253 Pf proteins) to determine antibody response in individuals enrolled in several attenuated sporozoite vaccine clinical trials. By comparing the antibody profiles from vaccinees which are protected with those who are not, we aim to identify surrogate antibody biomarkers associated with sporozoite vaccine mediated protection. There is now a major effort led by our collaborator, Sanaria Inc., to develop purified metabolically active, aseptic, vialed, and cryopreserved Pf sporozoite (PfSPZ) vaccines that prevent infection and transmission and are administered by needle and syringe injection. The first such PfSPZ vaccine has been attenuated by irradiation and is called the PfSPZ Vaccine. Recently, the group at Radboud University Nijmengen Medical Center (RUNMC) published on achieving complete protection against Pf by immunizing volunteers bythe bite of mosquitoes carrying viable (non-irradiated) PfSPZ while taking chloroquine chemoprophylaxis to prevent parasitemia. This protection has now been shown to be sustained for 2 years. Together, Sanaria and RUNMC have shown that they can infect volunteers by needle and syringe administration of viable PfSPZ, and studies to immunize chloroquine treated volunteers with purified viable PfSPZ to determine if they can duplicate the protection seen after administration by mosquito bite are pending. Approximately 1,500 serum specimens from these trials will be used for the biomarker discovery project proposed here. The aim will be to identify and validate these surrogate biomarkers of protection and to develop a validated test intended to be used as a pivotal FDA-required assay to support licensure of the sporozoite vaccine. PUBLIC HEALTH RELEVANCE: An effective malaria vaccine would greatly benefit millions of infants, children, pregnant women and others at risk of malaria disease and death throughout the malaria-endemic world, but thus far efforts to develop recombinant protein and viral vector vaccines have been disappointing despite intense efforts. This proposal takes advantage of recent discoveries showing that several live attenuated whole organism vaccines can provide robust protection from infection by the parasite. The study proposed here aims to probe a microarray containing 4,253 Pf proteins with hundreds of sporozoite vaccine clinical trial specimens to identify and validate surrogate antibody biomarkers of protection and to develop a validated test intended to be used as a pivotal FDA-required assay to support licensure of the sporozoite vaccine.


Patent
Immport Therapeutics, Inc. | Date: 2016-06-22

Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.91K | Year: 2016

DESCRIPTION provided by applicant Over a half billion individuals worldwide are infected with herpes simplex virus type and or type HSV andamp HSV which cause genital herpes Most HSV seropositive individuals are asymptomatic ASYMP and never have any recurrent herpetic disease In contrast a small proportion is symptomatic SYMP with frequent often lifelong bouts of recurrent herpetic disease a result of reactivation of latent HSV from sensory neurons of the dorsal root ganglia DRG Our long term goal is to develop an immunotherapeutic vaccine to prevent virus reactivation from latency and protect against recurrent genital herpes disease The most recent vaccine clinical trials that used HSV glycoprotein D gD failed to protect despite inducing strong HSV specific neutralizing antibodies This proposal emphasizes two major gaps in knowledge The need to induce cell mediated immune responses in addition to humoral responses for better protection The need to identify novel herpes T cell antigens Ags to be incorporated into next generation HSV vaccines A critical role for HSV specific sensory ganglia resident CD T cells in aborting HSV reactivation has been established and the involvement of CD T cells is gaining wider acceptance Paradoxically HSV specific genital tract GT resident CD and CD T cells are also involved in herpes pathogenicity The Ag specificities of protective and pathogenic CD and CD T cells remain to be elucidated Our recent published and preliminary data demonstrate that A CD and CD T cells from HSV seropositive SYMP and ASYM individuals differ in their HSV Ag specificities phenotype and function B Immunization of novel susceptible Human Leukocyte Antigen HLA A DR double transgenic mice HLA Tg mice with ASYMP Ags but not SYMP Ags induced a strong T cell dependent protective immunity against genital herpes Building on the above published and preliminary data in both humans and HLA Tg mice we hypothesize that CD and CD T cells specific to HSV Ags can be either protective or pathogenic and A vaccine strategy that can boost the number and or function of DRG resident protective CD and CD T cells will prevent or reduce virus reactivation and hence protect against recurrent genital herpes Our Specific Aims are Aim To confirm the hypothesis that there is a set of HSV Ags that are recognized mostly by CD and CD T cells from ASYMP individuals and a different set of Ags that are recognized mostly by CD and CD T cells from SYMP individuals Aim To test the hypothesis that immunization of HLA double Tg mice with immunodominant ASYMP Ags but not with SYMP Ags will induce DRG resident CD and CD T cells and protect against genital herpes infection and disease Successful completion of the proposed work should help build a strong foundation toward developing an effective genital herpes vaccine PUBLIC HEALTH RELEVANCE Genital herpes disease caused by HSV and HSV infections is a major global health problem This proposal focuses on both an antigen selection and delivery platform by performing high throughput screening of HSV and HSV genome to select the sets of HSV Ags that are exclusively recognized by CD and CD T cells from HSV seropositive ASYMP individuals with a history of controlled herpes disease and then using the selected ASYMP protective Ags as a vaccine against genital herpes Results from this preclinical study will pave the way toward developing a novel andquot ASYMPandquot vaccine for clinical application


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

DESCRIPTION (provided by applicant): HIV-1 causes the largest number of deaths from a single infectious agent in the world today. Despite considerable advances in treatment of HIV-1 infection and AIDS, which it causes, there is an urgent need for better methods of prevention and treatment of HIV-1 infection. The development of a safe and effective vaccine to prevent HIV-1 infection or the subsequent development of AIDS is therefore of the utmost importance. This effort, however, has been hampered by a lackof understanding of the correlates of protective immunity and a lack of the tools needed to measure effective anti-HIV-1 immune responses. We have developed a Multi-Clade HIV-1 Proteomic Chip (MC-HIV-1 chip) that can be used as a tool to rapidly screen antibody responses to HIV-1 elicited in vivo in response to infection or vaccination. The current version of the MC-HIV-1 chip which is available commercially from Antigen Discovery Incorporated (ADI) expresses over 100 HIV-1 proteins, protein fragments


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2015

DESCRIPTION provided by applicant There are many pathogenic organisms that cause disease in the oral cavity or that can be detected there Among these are three important viruses human immunodeficiency virus HIV human papilloma virus HPV and herpes simplex virus HSV HIV infection and disease is treatable but is costly and is still associated with considerable morbidity and mortality HPV is the primary cause of oropharyngeal cancer and HSV causes common oral lesions All of these pathogens can be spread by contact with saliva This is not a common route of transmission for HIV but it is nevertheless a concern since HIV causes AIDS which is a fatal disease It would therefore be desirable to have a simple cost effective point of care POC device for the detection of infection by HIV HPV and HSV We propose to use a protein microarray to detect HIV by antigen capture and to detect antibodies to each virus based on binding to viral proteins in the microarray Antigen Discovery Incorporated ADi has considerable experience in the development production and marketing of protein microarrays We now sell seventeen reactive protein antigen microarrays from a variety of pathogenic viruses bacteria and protozoa including an HIV array with proteins from the five most common subtypes Moreover ADi has already isolated all the genes from eleven serotypes of HPV HSV types and and inserted them into an expression vector for production of proteins In order to develop a useful POC device for the detection of HIV as well as antibodies against HIV HPV and HSV in saliva we have the following specific aims for the first phase of this project Create a proteomic microarray containing all proteins from all common types of HIV HPV and HSV Later we will expand the microarray to include other oral pathogens Develop a protocol for sensitive and specific screening for antibodies to oral pathogens in saliva using a proteomic microarray In Phase II a microfluidic device will be developed to automate the assay procedure Develop a sensitive and specific microarray based antigen capture detection assay for HIV In Phase II similar assays will be developed for HPV HSV and other oral pathogens and the assay procedure will be automated using a microfluidic device PUBLIC HEALTH RELEVANCE This project will create a prototype point of care device for detection of HIV and antibodies against HIV HPV and HSV in saliva We will develop a simple protocol for use of the device that will ensure sensitive specific detection of oral pathogens and antibodies against them in saliva


Patent
The Regents Of The University Of California, Immport Therapeutics, Inc. and Yale University | Date: 2013-12-12

Novel immunodominant antigenic proteins and peptides associated with associated with leptospirosis were identified using a proteome array based on expression of ORFs from a Leptospira genome. Compositions, methods, and uses of such antigenic proteins and peptides in the diagnosis and staging of leptospirosis infection and in compositions, methods, and uses of such antigenic is proteins and peptides in prophylactic and therapeutic vaccines are disclosed.

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