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DAVIDSON, NC, United States

Patent
Soymeds, Inc. | Date: 2010-01-25

The present invention relates to vaccines that are made in transgenic soybeans for use in humans, animals of agricultural importance, pets, and wildlife. These vaccines are used as vaccines against viral, bacterial, fungal, parasitic or prion related diseases, cancer antigens, toxins, and autologous or self proteins. The transgenic soybeans of the instant invention also can be used for inducing tolerance to allergens or tolerance to autoimmune antigens, wherein an individual shows hypersensitivity to said allergen or has developed autoimmunity to autologous or self proteins, respectively. The invention also relates to prophylactically treating individuals and/or populations prior to showing hypersensitivity to allergens. Other aspects of the invention include using the transgenic soybeans as an oral contraceptive, and the expression of protein adjuvants in transgenic soybeans.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 200.97K | Year: 2007

DESCRIPTION (provided by applicant): Edible vaccines have received much attention since, in theory, they represent a source of vaccine that would stimulate mucosal immune responses, be cost-effective to produce, be safe to administer, and be stable to ship throughout the world. Studies proposed in this collaborative STTR effort will develop an oral vaccine against a non-toxic form of Staphylococcus enterotoxin B (SEB) by expressing this immunogen in transgenic soybeans. Completion of such studies will be significant since SEB has been identified as a potential agent of bioterrorism, and since no vaccine is presently available. Furthermore, once transgenic soybeans expressing a non-toxic form of enterotoxin B have been produced, these stably transfected plant lines will forever be a renewable source of this edible vaccine. A demonstration of the feasibility and efficacy of expressing an edible human vaccine against a non-toxic, mutant form of SEB in soybeans will be accomplished by performing the following specific aims. Specific aim #1: Expression of an immunogen, mutant SEB, in transgenic soybeans. The purpose of this aim is to characterize expression of a mutant form of SEB in soy milk formulations for use in an oral vaccine. Specific aim #2: To determine the efficacy of soybean-derived SEB as a mucosal immunogen following oral administration. In specific aim #2, we will address whether expression of SEB in transgenic soybean plants can elicit high levels of immunity following oral immunization of mice. Results from these studies will determine the magnitude of the B and T lymphocyte responses following administration of this edible vaccine. In addition, the ability of this edible vaccine formulation to protect against an SEB toxin challenge in a mouse model will be tested. Taken together, these studies will represent a significant, practical advance for the use of edible vaccines that are expressed in transgenic soybeans. In addition, the availability of this renewable resource will provide a product for future Phase II studies.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 239.72K | Year: 2009

DESCRIPTION (provided by applicant): A variety of therapies have been attempted to treat Multiple Sclerosis. Such experimental therapies have included the administration of myelin basic protein, administration of peptides derived from myelin basic protein, injection of the myelin basic protein peptide motif mimic, glatiramer acetate, and most recently, treating with DNA encoding myelin basic protein. The early clinical trials using such therapy have showed no, or little, clinical benefit. Based on these past clinical trials, it is clear that more efficacious therapies for Multiple Sclerosis patients are needed. The overall goal for the SBIR Phase I studies proposed here is to develop a novel formulation for use in treating Multiple Sclerosis patients. To begin to accomplish this task, we will express a novel protein in transgenic soybean seeds. The successful expression of this novel protein will allow soy formulations to be tested for efficacy in treating Multiple Sclerosis. To accomplish this task, the following milestones are proposed: Milestone #1: A novel fusion protein for treating Multiple Sclerosis will be expressed in transgenic soybeans. In milestone #1, we will establish soybean lines and produce soybean seeds in bulk quantities that can be used to make soy formulations for characterization (Milestone #2) and for use in efficacy studies (Milestone #3). Milestone #2: We will characterize the novel soybean-derived fusion protein and demonstrate that this protein retains it normal properties and functionality. Milestone #3: Demonstrate that soy formulations made from seeds expressing the fusion protein shows efficacy in treating a model of Multiple Sclerosis. Despite the disappointments and limited success of human clinical trials aimed at treating Multiple Sclerosis, the potential for such therapies is too great to ignore. In this Phase I SBIR, we propose to express a novel fusion protein in transgenic soybeans so that soy formulations can be assessed for their efficacy in treating a model of Multiple Sclerosis. Success with this Phase I SBIR studies will set the stage for future SBIR studies which will demonstrate safety and efficacy of such therapy in Multiple Sclerosis patients. PUBLIC HEALTH RELEVANCE: Based on past clinical trials, it is clear that more efficacious therapies for Multiple Sclerosis patients are needed. The overall goal for the SBIR Phase I studies proposed here is to develop a novel formulation for use in treating Multiple Sclerosis patients. The successful expression of this novel formulation will allow testing for efficacy in treating Multiple Sclerosis.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 216.22K | Year: 2010

DESCRIPTION (provided by applicant): Thyroglobulin levels in the sera of thyroid cancer patients are routinely quantified using various agency-approved (e.g. FDA) immunoassays. Physicians frequently order these diagnostic immunoassays to determine thyroglobulin levels in their patients. Therefore it is not surprising that many different companies have developed their own diagnostic tests for purchase and use in the clinical laboratory. Despite the current availability of these numerous thyroglobulin immunoassays, each suffers from inherent limitations. In fact, it is not possible to accurately compare the results obtained from one thyroglobulin immunoassay with those obtained by another. There are two major problems which need to be solved. First, the lack of a universally consistent thyroglobulin standard contributes significantly to variability between FDA-approved immunoassays made by different suppliers. Presently, the only source of human thyroglobulin for use as a standard in immunoassays comes from cadavers or surgically removed human thyroid tissue. The heterogeneity of different lots of human-derived thyroglobulin is a limitation which has not been solved. Second, anti-thyroglobulin autoantibodies present in some thyroid cancer patients' sera can interfere with immunoassays that attempt to detect and quantify thyroglobulin. Currently, there are no clear solutions to either of these dilemmas. In this Phase I SBIR, we propose to solve two of the most significant problems plaguing FDA-approved thyroglobulin immunoassays by expressing human thyroglobulin in transgenic soybean seeds for use as a class II medical device analyte. Taking advantage of this novel platform for expressing thyroglobulin should allow us to produce a highly homogenous standard for immunoassays. Furthermore, the unique advantages of transgenic soybean-derived proteins (e.g. homogeneity, ease of purification, very low cost, elimination of human pathogen transmission, renewable green technology , etc.) will allow, for the first time, a practical solution for the elimination of anti-thyroglobulin autoantibodies that can interfere with immunoassays. These accomplishments should significantly enhance present day thyroglobulin immunoassays designed to diagnose and monitor patients with thyroid cancers. PUBLIC HEALTH RELEVANCE: In this Phase I SBIR, we propose to solve two of the most significant problems plaguing FDA-approved thyroglobulin immunoassays by expressing human thyroglobulin in transgenic soybean seeds for use as a class II medical device analyte. Taking advantage of this novel platform for expressing thyroglobulin should allow us to produce a highly homogenous standard for immunoassays. Furthermore, this will allow a practical solution for the elimination of anti-thyroglobulin autoantibodies that can interfere with immunoassays. These accomplishments should significantly enhance present day thyroglobulin immunoassays designed to diagnose and monitor patients with thyroid cancers.


Hudson L.C.,Soymeds, Inc. | Garg R.,Soymeds, Inc. | Garg R.,Chandigarh Institute of Microbial Technology | Bost K.L.,Soymeds, Inc. | And 3 more authors.
BioMed Research International | Year: 2014

Soybean seeds possess several inherent qualities that make them an ideal host for the production of biopharmaceuticals when compared with other plant-based and non-plant-based recombinant expression systems (e.g., low cost of production, high protein to biomass ratio, long-term stability of seed proteins under ambient conditions, etc.). To demonstrate the practicality and feasibility of this platform for the production of subunit vaccines, we chose to express and characterize a nontoxic form of S. aureus enterotoxin B (mSEB) as a model vaccine candidate. We show that soy-mSEB was produced at a high vaccine to biomass ratio and represented 76 theoretical doses of human vaccine per single soybean seed. We localized the model vaccine candidate both intracellularly and extracellularly and found no difference in mSEB protein stability or accumulation relative to subcellular environment. We also show that the model vaccine was biochemically and immunologically similar to native and recombinant forms of the protein produced in a bacterial expression system. Immunization of mice with seed extracts containing mSEB mounted a significant immune response within 14 days of the first injection. Taken together, our results highlight the practicality of soybean seeds as a potential platform for the production of functional subunit vaccines. © 2014 Laura C. Hudson et al. Source

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