FORT COLLINS, CO, United States
FORT COLLINS, CO, United States

Ventria Bioscience is a biotech company with a focus on human nutrition and human therapeutics. The company was established in 1993 in Colorado. The company's core technology is a genetically modified crop-based protein production system called ExpressTec. Wikipedia.


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Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 201.92K | Year: 2012

DESCRIPTION (provided by applicant): An acute or cumulative overdose of acetaminophen (APAP), following either therapeutic overdose or suicide attempts, can cause severe liver damage with the potential to progress to liver failure. APAP overdose accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year, making APAP the most frequent cause of drug-induced liver failure in the U.S. Currently, N- acetylcysteine (NAC) is the only antidote used clinically to ameliorate APAP-induced liver injury (AILI). However, the effectiveness of NAC declines rapidly after APAP ingestion. Therefore, developing new life-saving treatment is critically needed. In our preliminary study with milk- derived lactoferrin, we demonstrate that the lactoferrin has a profound hepato-protective effect in a murine model of AILI. In the present proposal, we will team up with scientists from Ventria Bioscience to investigate the feasibility of developing a noveltreatment o AILI with recombinant human lactoferrin (rhLF) produced by Ventria. There are two aims in the present proposal. Aim 1. Purification of rhLF from rice suitable for intravenous (i.v.) administration. We will purify sufficient amount of rhLF fromrice grain and formulate it for systemic administration to mice. Aim 2. Investigation of the feasibility of the rhLF in attenuating AILI in mice. We will determine the condition in which rhLF can exert maximal/optimal effect on AILI. We expect that the study will prove that the rhLF is able to protect mice from liver injury due to overdose of APAP and establish a base for further study in phase II STTR to develop a novel therapy for AILI. PUBLIC HEALTH RELEVANCE: Acetaminophen overdose cause severe liver damage and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths each year in the U.S. Based on our preliminary study, we propose to develop a novel therapeutic treatment with recombinant human lactoferrin.


Patent
Ventria Bioscience | Date: 2014-09-23

Provided herein are monocot seed compositions and methods of making a monocot seed product expressing high levels of recombinant Osp fusion protein. In some embodiments, a rice seed composition is used in the manufacture of a Lyme disease vaccine formulation. In some embodiments, the composition comprising the Osp fusion protein is admixed with a drug or pharmacologically active agent, such as an antibiotic.


Patent
Ventria Bioscience | Date: 2013-07-24

The invention is directed to food and food additive compositions comprising one or more human milk proteins produced in the seeds of a trangenic plant and methods of making the same. The invention is further directed to improved infant formula comprising such food supplement composition.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 307.51K | Year: 2015

DESCRIPTION provided by applicant The scope of this proposed study is to demonstrate the efficacy of recombinant human lactoferrin rhLF to act as an immune modulator through T cell regulation in distinct murine models of inflammatory bowel disease IBD which best recapitulate Crohnandapos s like ileitis and colitis Crohnandapos s disease CD affects as many as people in the United States with current therapies relying on anti inflammatories and immune modulators which are palliative at best or expensive TNF antibody therapies each of which have associated toxicities Therefore we propose to investigate the use of Ventriaandapos s rice derived rhLF in preclinical models to demonstrate its efficacy as a cost effective therapeutic option in th treatment of CD Lactoferrin LF is an endogenous anti inflammatory molecule secreted at mucosal sites within the body While originally identified as a key component of innate immunity because of its antimicrobial properties increasing evidence points to the ability of lactoferrin to additionally modulate the adaptive immune system making it an ideal therapeutic target for chronic mucosal inflammatory conditions such CD Our preliminary studies have effectively demonstrated the therapeutic potential of subcutaneous rhLF in a murine model of CD thereby negating its direct interaction with the intestinal microbiota and toxins Specifically rhLF administration significanly decreased na ve T cell infiltration and proliferation in the intestinal lamina propria mesenteric lymph nodes and spleen of wk old TNF ARE mice which similar to CD patients develop a spontaneous chronic transmural intestinal inflammation rhLF treated mice also exhibited improved histological indices and had improved intestinal barrier function indicating efficacy for rhLF to decrease inflammation in a preclinical model of CD Given the broad spectrum of disease phenotypes that CD encompasses from mild to severe disease involving strict ileitis colitis or both it is prudent to validate these findings in multple preclinical models Ventria Bioscience currently uses a rice expression system to produce recombinant human LF at high levels of purity at a cost effective scale and has demonstrated the safety and efficacy of rhLF in clinical trials when administered to human subjects Based on the proven safety record of rhLF and the capacity within Ventria for large scale production of this recombinant protein success in these phase I trials will allow us to rapidly translate these findings into a phase II clinical trial in pediatric patients Nonetheless we must first demonstrat that rhLF remains effective when administered orally and more crucially validate the protective effect of rhLF in an additional preclinical model of CD Specifically we seek to investigate the following Investigate the efficacy of oral rhLF in a relevant pre clinical model of chronic CD and demonstrate the mechanism of action of rhLF through its ability to enhance a pro regulatory environment Previous studies have used harsh and very acute chemical models of ulcerative colitis UC to demonstrate a protective effect of purified bovine or human LF when orally administered These studies did not attempt to demonstrate a clear mechanism of action of LF nor do the models themselves recapitulate the human condition very well Therefore we will test the efficacy of oral rhLF to induce remission in a chronic model of TNF driven ileitis TNF ARE which best displays the hallmarks of human disease We will investigate the role of rhLF in the regulation of specific T cell phenotypes characterized by their ability to exacerbate or suppress the inflammatory response The activity of rhLF is not limited to a single pre clinical model of CD by further investigating its immunoregulatory role in a T cell mediated model of colitis In an effort both to demonstrate that the effect of rhLF is not model specific ad to evaluate rhLFandapos s efficacy a model of Crohnandapos s like colitis a common feature of CD we have chosen a T cell driven model of colitis CD CD RBhigh adoptive transfer model In this model we will test the ability for rhLF to regulate T cell populations from the earliest to pervasive staes of inflammation with particular regard to the role of regulatory T cells Tregs and their abilityto suppress the pathogenic immune response Together these models will define an immunomodulatory role of rhLF in two distinct chronic models of CD testing the hypothesis that rhLF exerts its protective effect in part by induction of a pro regulatory environment within the intestine PUBLIC HEALTH RELEVANCE Crohnandapos s disease is a chronic debilitating and incurable disease that is increasing annually in both incidence and prevalence Current therapies fail to provide lasting disease remission have significant ill side effects and in the case of many of the targeted biologics are extremely expensive to administer to patients In the present application we propose to investigate the use of Ventriaandapos s rice derived recombinant human lactoferrin rhLF in pre clinical models of Crohnandapos s disease as an efficacious and cost effective alternative to current therapies


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 237.32K | Year: 2013

DESCRIPTION (provided by applicant): Recent studies in animal models demonstrate that an endogenous human intestinal mucin fragment, termed MUC17, augments intestinal cell restitution and enhances healing of experimental colitis, potentially opening a newdoor to effective treatment of ulcerative colitis. However, expression of MUC17 in E. coli, yeast, and insect cells has met great challenges due to low expression, improper folding or insolubility. Ventria scientists have developed a highly efficient protein expression system in rice grain and have used the system to produce several proteins which are now in the marketplace. In the present proposal, we would like to test the feasibility of employing the proprietary Ventria rice expression system to produceMUC17 at high levels. Furthermore, we will purify MUC17 from rice grain and test its biological function via in vitro cell culture studies. We hypothesize that MUC17, derived from rice grain, will promote cell migration and inhibit apoptosis, important functions in epithelial cell restitution of the colon. Successfully expressing functional MUC17 in rice grain at high levels will greatly enhance the research and development effort of this project and provide a path to commercialization of this novel proteinfor patients suffering from ulcerative colitis. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Ulcerative colitis is a chronic debilitating disease which is prevalent primarily in the Western world. Currently therapies rely on anti-inflammatory strategies (mesalamine and steroids) which are palliative at best, or expensive TNF antibodies which have associated toxicities. In the present application, we propose to use Ventria's world- leading protein expression system to produce high levels of human MUC17 fragment, an endogenous agent which restores the epithelial lining of the colon, thereby enabling commercialization of this novel protein in the treatment of ulcerative colitis.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 232.53K | Year: 2013

DESCRIPTION (provided by applicant): Diabetes has become a devastating epidemic worldwide. Insulin is commonly used as a treatment to help manage diabetes because of its ability to control blood glucose levels, and is in high demand worldwide, but it facesmultiple challenges including adverse metabolic side-effects, short in vivo pharmaceutical life, and high cost. Today, millions of people continue to suffer and die from diabetes and its related conditions. Therefore, there is an urgent need to develop novel, inexpensive hypoglycemic agents to treat and arrest the fast spreading of this debilitating disease. A recombinant proinsulin-transferrin (ProINS-Tf) fusion protein was recently found to facilitate an enhanced and sustained in vivo hypoglycemic efficacy compared to insulin. While this fusion protein holds great promise as a novel hepato-specific hypoglycemic agent that can overcome some of the disadvantages of insulin, its therapeutic use is currently economically unfeasible due to low yields and highcosts associated with its production in mammalian cell lines. In an effort to capture all the benefits of ProINS-Tf while lowering its supply cost, Ventria Bioscience and its collaborators at the University of Southern California are building on their respective expertise t express a ProINS-Tf chimeric protein in rice, and then assess its biological activities related to its usage as a novel hypoglycemic agent. This proposed project has three related specific aims. In Aim 1, Ventria will use its proprietaryexpression technology to transform rice plants with a chimeric gene construct composed of ProINS fused to Tf and will produce transgenic plants expressing ProINS-Tf. In Aim 2, Ventria will perform expression screening analysis to identify the transgenic events with the highest level expression of ProINS-Tf followed by protein purification. In Aim 3, Ventria's collaborators at the University of Southern California will confim the biological activities of ProINS-Tf through in vitro cell culture assays. The aims of these studies are to develop a novel and affordable hepatocyte prodrug for the treatment of diabetes. These studies are significant and relevant to the mission of the NIH to promote human health and reduce health care costs. PUBLIC HEALTHRELEVANCE PUBLIC HEALTH RELEVANCE: Diabetes is the largest and fastest-growing chronic, disabling and deadly disease affecting young and old people worldwide. Insulin is the commonly used therapy for management of diabetes, but it faces multiple challenges including short in vivo pharmaceutical life, adverse metabolic side-effects, and high cost. There is an urgent need to develop novel, inexpensive hypoglycemic agents to treat and arrest the fast spreading of this debilitating disease. This project investigates the feasibility of using a plant-based expression system to cost- effectively produce a newly discovered recombinant proinsulin-transferrin fusion protein, which has been shown to enhance and sustain in vivo hypoglycemic efficacy compared to insulin. The outcome of this project will benefit the development of novel and affordable treatments for diabetes, and is significant and relevant to the mission of the NIH to promote human health and reduce the health care costs.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.52M | Year: 2012

DESCRIPTION (provided by applicant): The Vero cell line is used in the production of viral based vaccines. The use of cell based vaccines based on the Vero cell line is growing. The majority of the vaccines in use today are produced using cell culture medium supplemented with serum. The use of animal-derived products in vaccine culture media presents a risk for the transmission of infectious disease on a wide scale. Current commercially available serum-free vaccine media are not defined, inconsistent, and do not offer the same performance as media supplemented with serum. We propose to produce a superior performance, defined, animal-free, cell culture medium for vaccine production. Our project addresses the call by agencies for a safe alternative to animal-derived components in vaccine production. PUBLIC HEALTH RELEVANCE: Epithelial cell lines such as Vero are used in the manufacture of viral based vaccines and their use is expanding. Current commercially available animal-free vaccine production media are not defined and do not offer the same performance as media supplemented with serum. We propose the industry's first defined, high performance animal-free, cell culture medium to increase the safety and the production of vaccines.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 260.89K | Year: 2014

DESCRIPTION (provided by applicant): Vascular diseases such as athersclerosis are the major causes of morbidity and mortality worldwide. The high density lipoprotein (HDL) particle is thought to protect the arteries from atherosclerosis by removing excesscholesterol and other lipids from the vessel wall and delivering them to the liver for elimination. The key protein component of HDL is apolipoprotein A-I (ApoA-I). A naturally occurring genetic variant, named ApoA-I Milano (ApoA-IM) is highly potent in reducing atherosclerotic vascular disease. This specific function of ApoA-IM and the HDL particle has become an important therapeutic focus in the HDL-based therapies. However, production of ApoA-IM is extremely difficult and costly thus limiting its therapeutic potential. Ventria Bioscience has developed a plant-based protein expression system in rice grain that produces recombinant protein generally 25 to 1000 fold higher than other plant-based protein expression systems. We hypothesize that we can use


Patent
Ventria Bioscience | Date: 2015-03-25

Disclosed are compositions and methods of making non-glycosylated transferrin protein in transgenic monocot plants.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 842.42K | Year: 2011

DESCRIPTION (provided by applicant): Patients treated with antibiotics frequently develop diarrhea. In developed countries, adults, particularly the elderly, experience a higher death rate due to diarrhea than children. Results from in vitro and preliminary in vivo studies lead us to hypothesize that oral administration of recombinant human lactoferrin as a medical food might be able to prevent and reduce antibiotic associated diarrhea in adults. The present fast track SBIR Phase I and II proposal plans totest this hypothesis with a clinical trial involving 260 subjects. In phase I, we will produce 25 kg of testing materials, recombinant human lactoferrin, from rice grain and at the same time obtain IRB approval of the clinical trial. In phase II, we will conduct the clinical study in four test sites in Baltimore. We expect that the study will prove that recombinant human lactoferrin is able to reduce incidence of antibiotic associated diarrhea by 50% and if patients do get diarrhea, the diarrhea days will be shorten by half. PUBLIC HEALTH RELEVANCE: The high death rate associated with diarrhea in adults compared to that in children in developed countries is commonly neglected. Oral administration of recombinant human lactoferrin might be able to prevent antibiotic associated diarrhea in adults and the present proposal is to test this hypothesis.

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