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There are an estimated three million cholera cases per year around the world and more than 8 million U.S. travelers per year going to countries where cholera occurs. More than 80 percent of reported U.S. cases are associated with travel to cholera-endemic countries in Africa, Asia and the Caribbean.1 Of the top 20 international destinations of U.S. travelers; five are to cholera-endemic countries, including the Dominican Republic, Jamaica, China, India and the Philippines. Additionally, in recent years, there has been a rapid spread and re-emergence of cholera in the Americas, with cases reported in Cuba, Mexico, Ecuador and Haiti. Despite this, cholera remains underreported. "Cholera has shown itself to be an emerging pathogen in the Western hemisphere," said Bradley A. Connor, M.D., Clinical Professor of Medicine at the Weill Cornell Medical College, Attending Physician at the New York Presbyterian Hospital-Cornell Campus and Medical Director, The New York Center for Travel and Tropical Medicine. "The recent outbreak in Haiti demonstrated that cholera can evolve to become an even larger issue in areas we haven't seen before. These new CDC guidelines will help educate healthcare providers who see travelers to consider vaccination for those who may be at risk for contracting cholera." Vaxchora, a single-dose vaccine, was approved by the U.S. Food and Drug Administration (FDA) in June 2016 for active immunization against disease caused by Vibrio cholerae serogroup O1. The approval was based on positive results from a 10-and 90-day cholera challenge trial that demonstrated vaccine efficacy of 90.3% at 10 days and 79.5% at three months post-vaccination, as well as two safety and immunogenicity trials in healthy adults. Cholera, transmitted by ingestion of food and water contaminated with Vibrio cholerae, is an important cause of diarrhea that may be severe and life-threatening in some individuals. If untreated, death may result in 24 hours.1 A recent report from the CDC suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems.3 Non-vaccine intervention to prevent cholera infection is the avoidance of contaminated water and food, but studies have shown that 98 percent of travelers do not comply with these precautions when traveling.4 Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas or in persons who have pre-existing immunity due to previous exposure to Vibrio cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by Vibrio cholerae serogroup O139 or other non-O1 serogroups. Vaxchora is contraindicated in people with a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of Vaxchora or to a previous dose of any cholera vaccine. The safety and effectiveness of Vaxchora have not been established in immunocompromised persons. Vaxchora may be shed in the stool of recipients for at least seven days. There is a potential for transmission of the vaccine strain to non-vaccinated close contacts (e.g., household contacts). Use caution when considering whether to administer Vaxchora to individuals with immunocompromised close contacts. The most common adverse reactions (incidence >3%) were: tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%). For the full Prescribing Information, please visit www.vaxchora.com. PaxVax is a leading independent vaccine company that is devoted to bringing specialty vaccines that protect against overlooked infectious diseases to market, providing effective tools for health care providers who serve the 100 million people per year who travel to  countries where these diseases are present. It commercializes vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora™), and has a robust pipeline with vaccines at various stages of preclinical and clinical development for adenovirus, chikungunya, hepatitis A, HIV and Zika. As part of its social mission, PaxVax is also committed to making its vaccines available for use in developing world and increasing access to vaccines for the people who need them most. More information is available at http://www.paxvax.com/. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cdc-recommends-that-adults-traveling-to-cholera-affected-destinations-get-vaccinated-with-vaxchora-cholera-vaccine-live-oral-300456352.html


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.97M | Year: 2012

DESCRIPTION (provided by applicant): Development of a vaccine to prevent, or reduce the rate of, HIV infections remains a high priority despite recent setbacks in the field. The lessons from failed and successful experimental programs indicate the need toapply new approaches to HIV vaccine design with the goal of inducing immune responses that are the appropriate type, quality, magnitude and active in the appropriate sites in the body. A promising approach is the use of the Adenovirus serotype 4 (Ad4) as avaccine delivery vehicle. The Ad4 virus is a component in the US Military adenovirus vaccine which was formulated for administration in an oral dosage form. Oral delivery should be advantageous for HIV vaccines because this route of administration is morelikely to induce mucosal immune responses than parenteral injection and would target the gut mucosal tissues in particular. The Ad4 vaccine vector is replication-competent in humans which should drive the induction and expansion of immune responses that are different, in terms of magnitude and effector functions, than those induced by non- replicating vectors. In Y1, multiple Ad4 vectors will be engineered to express unique antigens including: 1) HIV-1 Env clade C protein for the purpose of inducing antibody responses broadly effective against a variety of HIV strains; 2) GBV-C E2 glycoprotein, which may induce antibodies that block HIV-1 cellular attachment; and 3) Gag protein, which may induce T cell responses which promote killing of HIV-1 virus infectedcells. Since human adenoviruses such as Ad4 do not replicate in non-human animals, including NHPs, we will also construct analogous replicating Simian adenovirus (SAd7) vectors to allow a direct comparison of the efficacy of Ad4 (non-replicating vector inNHPs) with an analogous replicating vector, SAd7. All vectors will be assessed for immunogenicity in small animals (mice /rabbits) before proceeding to NHP studies in Y2. Once immunogenicity is confirmed in NHPs, we will evaluate their efficacy in an NHPR5 SHIV clade C challenge study. Both antibody (neutralizing and ADCVI) and T cell immune responses (IFN- ) will be determined. Completion of this SBIR program will provide sufficient data to determine the utility of this Ad4 vector system for inducing effective antibody and T cell responses and potentially could yield an experimental vaccine suitable for clinical development. PUBLIC HEALTH RELEVANCE: The development of a safe and protective vaccine against the Human Immunodeficiency Virus (HIV) that causes AIDS has been very difficult. The proposed research will modify an existing adenovirus vaccine, which was used safely in more than 10 million people, so that it expresses HIV proteins and induces an immunological response in animals. This vaccinewill have advantages of being a live virus vaccine, such as the polio or measles vaccines, which can be taken by mouth without risk of causing HIV infection.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 548.82K | Year: 2012

DESCRIPTION (provided by applicant): Development of a vaccine to prevent, or reduce the rate of, HIV infections remains a high priority despite recent setbacks in the field. The lessons from failed and successful experimental programs indicate the need toapply new approaches to HIV vaccine design with the goal of inducing immune responses that are the appropriate type, quality, magnitude and active in the appropriate sites in the body. A promising approach is the use of the Adenovirus serotype 4 (Ad4) as avaccine delivery vehicle. The Ad4 virus is a component in the US Military adenovirus vaccine which was formulated for administration in an oral dosage form. Oral delivery should be advantageous for HIV vaccines because this route of administration is morelikely to induce mucosal immune responses than parenteral injection and would target the gut mucosal tissues in particular. The Ad4 vaccine vector is replication-competent in humans which should drive the induction and expansion of immune responses that are higher in quality, in terms of magnitude and effector functions, than those induced by non-replicating vectors. In Y1, multiple Ad4 vectors will be engineered to express unique antigens including: 1) HIV-1 Env clade C protein with the appropriate modifications for the purpose of inducing antibody responses broadly effective against a variety of HIV strains; and 2) GB virus type C E2 protein, which may induce synergistic antibody responses which would significantly broaden HIV-1 neutralization. In Y1-Y2,all vectors will be assessed for immunogenicity in small animals (rabbits). HIV-1 Env-specific antibody, both neutralizing and binding, will be determined. Completion of this SBIR program will provide sufficient data to determine the utility of this Ad4 vector system for inducing effective antibody and T cell responses and potentially could yield an experimental vaccine suitable for clinical development. PUBLIC HEALTH RELEVANCE: The development of a safe and protective vaccine against the Human Immunodeficiency Virus (HIV) that causes AIDS has been very difficult. The proposed research will modify an existing adenovirus vaccine, which was used safely in more than 10 million people, so that it expresses HIV proteins and induces an immunological response in animals. This vaccine will have the advantage of being taken by mouth and the advantages of a live virus vaccine, such as the polio or measles vaccines but will not have any risk of causing HIV infection.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1.00M | Year: 2015

Adenoviruses are a frequent cause of epidemic acute respiratory disease (ARD) in military recruit training centers and pose a significant threat to military readiness, especially during times of large mobilization. There are no FDA-licensed treatment options available for adenovirus infections. Under the SBIR phase I, PaxVax successfully re-developed research-grade Ad4 and Ad7 capsule vaccines with comparable potency to the Teva Ad4 and Ad7 Tablet vaccines using modernized platform technologies, including a high-yield continuous cell line, serum-free medium, single-use bioreactor and purification technologies, new thermostable formulations and aqueous enteric-coating. During the SBIR Phase II, PaxVax will cGMP manufacture clinical Ad4/Ad7 vaccines with processes and assays developed under the SBIR I. PaxVax will produce Ad4/Ad7 cGMP master viral seeds (MVS) with plaque-purified and amplified pre-MVS, bulk drug substances (BDS), and final drug products (FDP), and subsequently release these products for clinical trials. The produced Ad4/Ad7 FDP will also be placed on a stability program as required to support the trials. A small clinical trial will be conducted to evaluate the safety and immunogenicity of a single dose of the PaxVax Ad4/Ad7 vaccines. A successful clinical trial will in turn advance the production processes to a commercial production stage.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 298.46K | Year: 2012

DESCRIPTION (provided by applicant): The 2009 H1N1 pandemic illustrates a critical weakness in our ability to respond to a pandemic threat. The ability to ramp up production of vaccine doses within the critical period from the discovery of the threat is hindered by two major supply constrictions: 1) production technology for producing influenza vaccines in eggs; and 2) the logistical considerations involved in deploying and delivering a refrigerated parenteral vaccine by trained personnel. Our Ad 4 vaccinevector encoding influenza antigens and a delivered oral dosage form addresses both of these issues. This project focuses on developing a old technique to be applied in a new way to increase the speed and scale of producing live vaccine powder in both a convention form and in a coated form. That technique utilizes spray drying to replace lyophilization as a drying method. The program also consists of enteric coating of adenovirus technology that can be incorporated in a manufacturing process suitable for drying the vector. Spray drying is unique in that the coating and drying process are achieved simultaneously. The resulting enteric coated vector platform could be used for widely different vaccine applications, and would therefore save both time and money indevelopment of vaccines against emerging diseases, bioterror threats, and pandemics. PUBLIC HEALTH RELEVANCE: Spray Drying, a simple and versatile manufacturing process to make powder products in bulk for vaccines and biologics. Spray drying process for biologics allows meeting any emergency needs at low cost per dose through economies of scale. A Spray Drying process manufacturing site can be commissioned anywhere in the world in the event of an emergency situation.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 99.95K | Year: 2014

Adenoviruses are a frequent cause of epidemic acute respiratory disease (ARD) in military recruit training centers and pose a significant threat to military readiness, especially during times of large mobilization. There are no FDA-licensed treatment options available for adenovirus infections. The objective of this proposal is to re-develop Ad4 and Ad7 live viral vaccines which will 1) modernize commercial scale production, 2) reduce cold chain vaccine distribution and storage logistics, and 3) develop a production platform that can be readily applied to other adenovirus serotype vaccine candidates. In this proposal, we will develop Ad4 and Ad7 live, oral delivery vaccines comparable to the existing FDA-licensed vaccines, but using modernized Ad4 platform technologies that are currently in use or in development at PaxVax, including: ? Novel A549 cell substrate: A549 continuous cell line to enable large-scale bulk adenovirus production using serum free medium in disposable, closed bioreactor; ? Thermostable formulation: room temperature stable formulation compatible with both freeze drying and spray drying process technologies; ? Spray-drying: replace the lyophilization process with a spray-drying process to improve control and product consistency; ? Oral capsule dosage form: use of modern aqueous enteric coating material to manufacture oral dosage capsules as final drug product.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.77M | Year: 2015

DESCRIPTION provided by applicant Development of a HIV vaccine to prevent or reduce the rate of infection remains a high priority The lessons from numerous failed and the recent modestly successful RV Thai trial indicate the need to advance new approaches to HIV vaccine design with the goal of inducing immune responses that are the appropriate type quality magnitude and active in the appropriate sites in the body Our strategy is to build upon the RV study which implemented a canarypox vector prime T and B cell immunogens followed by a recombinant envelope Env protein boost immunization The primary objective of this project is to assess an immunization strategy to induce broadly neutralizing antibodies BnAbs in nonhuman primates based on vaccines containing recombinant simian adenovirus SAd viral vectors and HIV Env glycoproteins selected from sequential isolates of an HIV infected individual that ultimately developed CD binding site BnAbs The premise of this approach is to engage naive B cell receptors of BnAbs and continue to immunize with select immunogens to stimulate somatic mutation that leads to induction of BnAbs Our central hypothesis is that the combination of replicating adenovirus persistently expressing Envs selected at critical junctions during development of BnAbs will be efficient vaccine immunogens for inducing protective antibodies against HIV infection It will be evaluated whether serial or swarm immunization with SAds expressing Envs delivered with matching Env glycoprotein immunogens can induce BnAbs The recombinant SAdEnv vectors will be assessed for immunogenicity in rabbits before proceeding to NHP studies in Year Both antibody binding neutralizing and ADCVI and Env specific T cell immune responses will be evaluated Completion of this SBIR II program may provide sufficient data to determine the utility of the replicating adenovirus vector system for expressing B cell lineage Envs and potentially could yield an experimental vaccine suitable for clinical development PUBLIC HEALTH RELEVANCE The development of a safe and protective vaccine against the Human Immunodeficiency Virus HIV that causes AIDS has been very difficult The proposed research will modify an existing adenovirus so that it expresses HIV proteins and induces an immunological response against HIV virus in animals Ultimately this research may lead to a human HIV vaccine that will be safe have the advantage of being taken by mouth and the advantages of a live virus vaccine such as the polio or measles vaccines but will not have any risk of causing HIV infection


Patent
Paxvax, Inc. | Date: 2012-06-01

The present invention provides formulations comprising nanocoated biological materials (e.g., viral particles), methods for producing powders comprising nanocoated biological materials, and powders produced from such formulations and methods. Also provided are pharmaceutical compositions comprising the present formulations or dried powders, and vaccines comprising the present formulations or dried powders. The nanocoated biological materials typically display superior stability for either direct use in a formulation or in drying processes to produce a powder material, wherein the coated materials are typically more tolerant to environmental stress (e.g., chemical, thermal, and/or mechanical stress) during storage or drying processes.


Patent
Paxvax, Inc. | Date: 2012-02-24

The present invention is directed to formulations for spray-drying viral particles, methods for spray drying such compositions, and pharmaceutical compositions and vaccines comprising the present spray-dried powders. The present formulations advantageously provide for spray-drying viral particles at low temperatures, thereby producing spray-dried viral powders having viral infectivities comparable to those of powders prepared by lyophilization of comparable formulations. The methods and compositions described herein advantageously provide substantially higher throughput and production rates for the production of viral powders. Further, spray-dried viral powders incorporating enteric polymers can be produced at low temperatures.


Patent
Paxvax, Inc. | Date: 2014-09-05

The present invention provides replication competent adenoviral vectors capable of expressing antigens from infectious pathogens, such as influenza virus. The adenoviral vectors can be used to vaccinate subjects against the infectious pathogens. The adenoviral vectors comprise heterologous sequences encoding the antigens. The heterologous sequences can be inserted into various locations in the adenoviral vectors, including in or near specific E3 deletions and/or integrated into the adenoviral hexon coding region. The adenoviral vectors can be derived from any adenoviral serotype, particularly an Ad4 or Ad7 serotype.

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