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DOYLESTOWN, PA, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 598.00K | Year: 2010

DESCRIPTION (provided by applicant): Influenza viruses are highly infectious RNA viruses that cause epidemic respiratory disease in the human population. There is an urgent unmet need for an influenza vaccine with greater potency, durability of antibody response, and strain-cross reactivity that can be developed more rapidly than conventional influenza virus. The recent epidemic spread of H1N1 and H5N1 viruses underscores the need to design vaccines that are more effective against new strains. Influenza vaccines developed using the existing model are susceptible to failure since significant HA and NA antigenic variation can occur in the time that elapses from selection of the vaccine candidate strain and virus exposure. Vaccine that have built-in cross-subtype efficacy could prevent significant spread of an emerging or re-emerging strain. A universal vaccine would have to spur an immune system attack on part of the influenza virus that does not vary from strain to strain. A cross-subtype vaccine containing immunogenic consensus sequence epitopes could achieve this goal, which is the focus of this proposal. We hypothesize that vaccines based on defined epitopes presented by the infected cells is far superior than protein subunit or motif predicted epitopes based vaccines because free proteins processing by the immune system may be different from the same protein in the viral particles. The overall objective of this proposal is to develop a novel universal influenza vaccine, which encompasses cross reactive humoral and cell mediated antigenic epitopes. In this phase I proof of concept proposal, we will extend our preliminary studies to identify a panel of HLA-A2 processed and presented cross strains conserved epitopes directly from influenza virus infected cells. These T cell epitopes will be combined with B cell epitopes in a gold glyconanoparticle vaccine delivery system and characterized for influenza specific T and B cell responses. In the phase II, additional HLA supertypes specific shared epitopes will be identified and combined with the conserved B cell eptiopes for the development of a universal influenza vaccine. PUBLIC HEALTH RELEVANCE: Influenza viruses cause repeated infections in humans and are a significant cause of morbidity and mortality annually accounting over 36,000 deaths each winter in the United States. The recent epidemic spread of H1N1 and H5N1 viruses underscores the need to design vaccines that are more effective against new strains. Influenza vaccines developed using the existing model is susceptible to failure since significant antigenic variations exist between the strains and mutation that occur more rapidly than most other viruses. A person who develops immunity to one strain of the virus is not well protected from a different strain. There is an urgent unmet need for an influenza vaccine with greater potency, durability of antibody response, and strain- cross reactivity that can be developed more rapidly than conventional influenza virus. In this phase I program, we will identify a panel of cross strains conserved T cell epitopes from influenza virus and combine with the conserved B cell eptiopes in a gold glyconanoparticle vaccine delivery system and characterize influenza specific immune responses for the development of a universal flu vaccine that would generate long lasting cross protective T cell and antibody responses against influenza family of viruses.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 1.08M | Year: 2008

DESCRIPTION (provided by applicant): Our over-all goal has been to develop a diagnostic test for the early detection of liver cancer (hepatocellular carcinoma (HCC)) that is more specific and sensitive than existing, approved diagnostic tests and procedure s. Using glycoproteomic discovery methods, we identified several glycoproteins whose serum amounts and degree of fucosylation appear to correlate with a diagnosis of HCC. In Phase I, as planned, we conducted extensive evaluations of three of the most promi sing detection markers which were selected based on their out-performance of AFP, the standard of care, in their ability to detect early-stage HCC. In addition, as planned, we have succeeded in developing a high throughput- compatible, lectin-ELISA for the highly promising marker Fuccosylated (Fc)-Kininogen. In phase I, we developed and validated a lectin-ELISA for Fc-Kininogen and generated preliminary, pre-validation data that demonstrate that this is a highly sensitive and selective marker for early-stag e HCC. In pre-validation studies, our Fc-Kininogen lectin-ELISA assay had a sensitivity of 93%, a specificity of 90%, a positive predictive value (PPV) of 93% and a negative predictive value (NPV) of 90%, far exceeding the performance of the standard AFP a ssay. These results satisfied the criteria for our Go decision to proceed to Phase II. In phase II, larger scale validation studies will be performed using a large serial and cross sectional patient population, and data generated with the Fc-Kininogen as say will be compared with the existing AFP diagnostic assay to generate the clinical data needed for pre-market approval of a new in vitro diagnostic test for HCC. We intend to work with a commercial partner that can manufacture, market and distribute the commercial assay for us and have already initiated commercialization discussions with a major U.S. diagnostics company. Accomplishing these aims will permit the introduction of a highly sensitive and specific diagnostic tool for the early detection of HCC. Given the need for early diagnosis for HCC to facilitate early and efficacious intervention, the introduction of a new non-invasive, high throughput, highly sensitive and specific diagnostic based serum assay is extremely important.HCC Diagnostics defined by fucosylated serum biomarkers. Diagnosis and intervention at an early stage is critical to reducing the number of liver cancer-related deaths. We have discovered novel biomarkers and completed the assay development work in our phase I application. In th is phase II, we propose to develop and validate a noninvasive, highly sensitive and selective early diagnostic test for liver cancer that can potentially be applicable to HBV or HCV positive and negative patients. Our ultimate goal is to develop an early d etection diagnostics that can be used as a routine clinical screen in patients with high risk for developing liver cancer.


Patent
Midatech and Immunotope, Inc. | Date: 2012-09-07

The present invention provides a vaccine for the prophylactic or therapeutic treatment of a tumour in a mammalian subject, as well as methods of using the vaccine, including in treatment of tumours and in generating a CTL response. The vaccine comprises a plurality of nanoparticles and a pharmaceutically acceptable carrier, salt or diluents. The nanoparticles comprise a core comprising a metal and/or a semiconductor atom; and a corona comprising a plurality of ligands covalently linked to the core, wherein at least a first ligand of said plurality comprises a carbohydrate moiety that is covalently linked to the core via a first linker, and wherein at least a second ligand of said plurality comprises an epitopic peptide that is covalently linked to the core via a second linker, said second linker comprising a peptide portion and a non-peptide portion, wherein said peptide portion comprises the sequence X


The present invention relates to compositions and methods for the prevention, treatment, and diagnosis of cancer, especially carcinomas, such as ovarian carcinoma. The invention discloses peptides, polypeptides, and polynucleotides that can be used to stimulate a CTL response against cancer.


The present invention relates to compositions and methods for the prevention, treatment, and diagnosis of cancer, especially carcinomas, such as lung carcinoma. The invention discloses peptides, polypeptides, and polynucleotides that can be used to stimulate a CTL response against lung and other cancers.

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