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Methods for generating immune responses using adenovirus vectors that allow multiple vaccinations with the same adenovirus vector and vaccinations in individuals with preexisting immunity to adenovirus are provided.


Methods for generating immune responses using adenovirus vectors that allow multiple vaccinations with the same adenovirus vector and vaccinations in individuals with preexisting immunity to adenovirus are provided.


Patent
Etubics Corporation | Date: 2017-02-15

Methods for generating immune responses using adenovirus vectors that allow multiple vaccinations with the same adenovirus vector and vaccinations in individuals with preexisting immunity to adenovirus are provided.


Methods for generating immune responses using adenovirus vectors that allow multiple vaccinations and vaccinations in individuals with preexisting immunity to adenovirus are provided.


Methods for generating immune responses using adenovirus vectors that allow multiple vaccinations with the same adenovirus vector and vaccinations in individuals with preexisting immunity to adenovirus are provided.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 202.65K | Year: 2014

DESCRIPTION (provided by applicant): With the discovery of new biomarkers associated with tumor development, many of these tumor-associated antigens (TAA) are being utilized in immunotherapeutic modalities designed to induce anti-tumor directed cytotoxicimmune responses. It is increasingly clear that not any one of these TAA is sufficient, as a single entity to develop an immunotherapeutic treatment agent. Consequently, our efforts are being focused on developing multi-targeted immunotherapeutic approachagainst TAA. The overall goal of the current project is to expand our immunotherapeutic approach for the treatment of metastatic colorectal cancer (mCRC) using a multiple targeted approach. Drs. Jeffery Schlom and James Gully at the National Cancer Institute have agreed to collaborate with us to reach this goal. We have achieved safety, dose response, and an increased overall survival in mCRC patients using our Ad5 [E1-, E2b-]-CEA(6D) (ETBX-011) immunotherapeutic as a single agent. We believe that addi


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 163.41K | Year: 2011

DESCRIPTION (provided by applicant): The objective of this project is to develop a therapeutic strategy for H V-associated malignancy based on the role of HPV in the pathogenesis. HPV related cancers express the E6/E7 oncoproteins of HPV that are ideal targets for immune inducing vaccines. We will develop a vaccine based upon a novel adenovirus serotype-S vector (Ads) platform with unique and additional deletions of the viral DNA polymerase and the pre- terminal protein in the early gene 2b (E2b) region (Ads [E1-, E2b-]). In studies employing HIV antigens, we reported that the new Ad5 [E1-, E2b-]-HlV vector vaccine was superior to a current Ads [E1-]-H V vector vaccine (containing deletion in the early gene 1 (E1) region) when used to induce CMI responses ina multiple immunization regimen. Significant antigen specific CMI responses were induced in mice and monkeys despite the presence of pre-existing AdS immunity. We will construct and produce an AdS [E1-, E2b-] vector vaccine that contains the HPV oncoproteins E6/E7 with non-oncogenic function. This new recombinant adenovirus will induce immune responses by expressing the modified HPV-E6/E7 antigens after direct transfection of antigen presenting cells. We will evaluate this in combination with a toll-like receptor agonist (TLRa) designed to enhance immune responses induced by the vaccine. Our pre-clinical data indicate that the AdS [E1-, E2b-] vec*or induces robust CMI responses against tumor associated antigen [fAA), even in the presence of pre- existing AdS immunity. In a murine cancer model employing the carcinoembryonic antigen (CEA) gene insert, tl.g -CEA immunogenicity and in vivo anti-tumor effects of repeated immunizations with i new AdS [E1-, E2b-l- GEA were compared to those observed with a currentgeneration Ads tE1-l-CEA. These AdS vectors were tested in a clinically relevant AdS immune setting. We observed that AdS immune mice immunized multiple times with AdS [E1-, E2b-]-CEA induced CEA-specific CMI responses that were significantly increased over those detected in AdS immune mice immunized multiple times with a current generation AdS tE1-l-CEA. Ads immune mice bearing CEA expressing tumors that were treated with AdS [E1-, E2b-J-CEA had an increased anti-tumor response as compared to AdS [E1-I-CEAtreated mice. These results demonstrate that AdS [E1-, Ezb-l-CEA can induce CMI immune responses that result in tumor growth inhibition despite the presence of pre-existing AdS immunity. We have also utilized the Ads [E1-, Ezb-] vector platform expressingthe TAA HER2lneu as a breast cancer immunotherapeutic agent. Ads [E1-, E2b-l-HERZlneu induced potent CMI against HER2/neu and significantly inhibited progression of established tumors in Ad5 immune mice. These data demonstrate that in vivo delivery of Ad5[E1-, E2b-] vectors expressing TM can induce anti-TAA immunity and inhibit progression of tumors in AdS immune animals. PUBLIC HEALTH RELEVANCE: In this study, we will develop a new adenoviral based drug (AdS [E1-, E2b-I-HPV-E6/7) to treat HtV+ patients with HPv-associated oropharyngeal and tonsillar ,ncers. The treatment platform is needed to overcome pre-existing AdS immunity that has prevented the widespread use of this type of technology.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 199.99K | Year: 2011

This Phase I, SBIR contract is for the development of a new vaccine targeting HER2/neu expressing breast cancers. The vaccine induces both cell-mediated and humoral immunity and the company is planning a first-in-man Phase I/Phase II clinical trial. It isanticipated that this new biotherapeutic product will complement and add to the armamentarium of existing therapies that treat HER2/new expressing breast cancers. In this SBIR Phase I study, the project will (1) manufacture the Ad5 [E1-, E2b]-HER2/new therapeutic product under cGLP, (2) perform toxicity evaluations of the therapeutic product, (3) collect and freeze organs/tissues for biodistribution studies. Etubics is developing a new vaccine targeting HER2/neu expressing breast cancers. The vaccine induces both cell-mediated and humoral immunity and we are planning a first-in-man Phase 1111 clinical trial. It is anticipated that this new biotherapeutic product will complement and add to the armamentarium of existing therapies that treat HER2/neu expressing breast cancers. The product consists of our novel Adenovirus serotype-5 vector platform (Ad5 [E1-, E2b-]-HER2/neu) that induces HER2/neu specific immunity in naIve and Ad5 immune pre-clinical animal models. Treatment with the product reduces tumorvolume in established HER2/neu positive tumors and prevents tumor implantation and progression. The product is manufactured in the Company's necessary and sufficient E.C? human cells. A Master Cell Bank has been produced under cGMP conditions. In SBIRPhase I studies, we will (1) manufacture the Ad5 [E1-, E2b]HER2/ neu therapeutic product under cGLP, (2) perform toxicity evaluations of the therapeutic product, and (3) collect and freeze organs/tissues for biodistribution studies. Upon completion of these studies, the Company will be prepared to cross-file with our FDA approved Ad5 [E1-, E2b-]-CEA IND and initiate manufacture of clinical grade material for a Phase 1111 clinical trial in breast cancer patients. Provide key


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2011

Etubics Corporation is clinically testing a new vaccine targeting carcinoembryonic antigen (CEA) expressing cancers in a Phase I/II clinical trials under FDA IND14325. Many cancers express CEA, including colon, breast and pancreatic cancers. It is anticipated that this new biotherapeutic product will complement the armamentarium of existing therapies for the treatment of CEA expressing cancers. The product consists of the Company s novel Adenovirus serotype-5 platform expressing CEA (Ad5 [E1-, E2b-]-CEA) that induces antibodies and cell mediated immune responses that result in anti-tumor activity. The product is manufactured in the necessary and sufficient human E.C7 cell line. A Master Cell Bank has been produced under cGMP conditions. In this Phase II SBIRprogram, we will (1) evaluate the robustness of the manufacturing process, (2) perform an additional GMP manufacturing run to support the next phase clinical trials, (3) perform a product biodistribution study in animals, (4) develop functional assays using the therapeutic product, and (5) perform shelf-life studies of the product. It is expected that completion of these processes and studies will allow us to produce sufficient product to support large-scale clinical trials required to move toward approvalof this new biotherapeutic for active immunotherapy of CEA expressing cancers.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.48M | Year: 2013

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