Longhorn Vaccines and Diagnostics, LLC

Luke T Daum

Gerald Walter Fischer

Clara Jebet Sei

Richard F Schuman

Jeffrey D Fischer

Gerald W Fischer

Clara Jabet Sei

Gerald W Fisher

The invention is directed to compositions and methods for collecting, transporting, and storing, without refrigeration, biological materials, which may comprise samples of biological, clinical, forensic, and/or environmental origin. These compositions preserve the viability of the collected organisms and/or the RNA/DNA and proteins in the sample composition mixture and permit the long-term storage of samples. Compositions are compatible with subsequent manipulation of the sample, including propagation and culture of the collected microorganisms, or isolation, purification, detection, and characterization of proteins, nucleic acids, and other macromolecules. When the compositions containing microorganisms and any polynucleotides therein are further processed, such as by nucleic acid testing, there is an increased ability to detect, isolate, purify and/or characterize select microbes and their components, such as nucleic acids, when compared to conventional microbial transport media that contain interfering substances and RNA/DNA extraction is not required prior to PCR analysis. In particular, the compositions disclosed allow for the collection, transport and storage of biological samples for extended periods at ambient temperature, while maintaining the integrity of the macromolecules of the sample for subsequent extraction, identification, and quantitation.

Multipurpose compositions for collecting and transporting biological material

The invention relates to composite antigens comprising an antigen obtained or derived from an antigenic epitope of one or more pathogens that induces an immune response in a mammal, an antigen obtained or derived from bacterial cell wall material that induces an immune response in a mammal such as LTA, PNG or LPS, and a T cell stimulating antigen such as CRM. Preferably the composite antigen comprises an immunogenic composition or a vaccine that is effective against the pathogen or can generate antibodies that can be collected that are protective against infection by the pathogen. In addition, the invention relates to vaccines comprising composite antigens and to method for treating and preventing an infection.

Immunogenic antigens

The invention relates to composite antigens comprising a peptide with contiguous amino acid sequence derived from a plurality of antigenic epitopes of one or more pathogens that induces an immune response in a mammal that is protective against infection by the one or more pathogens. In addition. The invention also relates to antibodies to composite antigens of the invention and to methods of administering vaccines comprising antigens or vaccines of antibodies for treating and/or preventing an infection.

Immunogenic compositions to treat and prevent microbial infections

Disclosed is an enhanced method for rapid and cost-effective analysis of sequences of a microorganism by semi-conductor sequencing, preferably ion-torrent sequencing. This method provides for full length analysis and of multiple areas (e.g. genes) of multiple genomes. These methods identify genetic mutations of a particular gene that are responsible for conferring resistance or sensitivity to an antibiotic or other chemical compound. Multiple different species, strains and/or serotypes of a particular organism are rapidly and efficiently screened and mutations identified along with the complete genome of an organism. By selecting primers pairs of similar size and GC content that produce amplicons with sequences spanning the entire genome, a single PCR reaction analyzed by ion torrent methodology can determine the sequence of a complete genome. Methods are useful to sequences the genomes of viral agents, such as influenza virus, and bacterial agents, such asbacteria.

Next generation genomic sequencing methods

The invention is directed to compositions and methods for rapidly detecting, amplifying, and quantitating one or more pathogen-specific nucleic acids in a biological sample, and in particular, samples obtained from patients with sepsis. The invention also provides diagnostic kits containing specific amplification primers, and labeled detection probes that specifically bind to the amplification products obtained therefrom. The invention is also directed to detecting the quantity or ratio of genomic sequences and mRNA sequences of an individual suspected of being infected with an infectious agent over time to assess the progress of the infection over time. Also disclosed are compositions and methods for the isolation and characterization of nucleic acids that are specific to one or more pathogens, such as, for example, Influenza virus,, and/or HIV from a wide variety of samples including those of biological, environmental, clinical and/or veterinary origin.

Compositions and methods for detecting and quantifying nucleic acid sequences in blood samples

The invention is directed to compositions and methods for isolating, detecting, amplifying, and quantitating pathogen-specific nucleic acids in a biological sample, and in particular PCR ready compositions that contain enzyme and are stable or long periods of time. The invention also provides diagnostic kits containing specific amplification primers, and labeled detection probes that specifically bind to the amplification products obtained therefrom. Also disclosed are compositions and methods for the isolation and characterization of nucleic acids that are specific to one or more pathogens, including for example Influenza virus and, from a wide variety of samples including those of biological, environmental, clinical and/or veterinary origin.

PCR ready compositions and methods for detecting and identifying nucleic acid sequences

Disclosed are compositions for isolating populations of nucleic acids from biological, forensic, and environmental samples. Also disclosed are methods for using these compositions as one-step formulations for killing pathogens, inactivating nucleases, and releasing polynucleotides from other cellular components within the sample, and stabilizing the nucleic acids prior to further processing or assay. The disclosed compositions safely facilitate rapid sample collection, and provide extended storage and transport of the samples at ambient or elevated temperature without contamination of the sample or degradation of the nucleic acids contained therein. This process particularly facilitates the collection of specimens from remote locations, and under conditions previously considered hostile for preserving the integrity of nucleic acids released from lysed biological samples without the need of refrigeration or freezing prior to molecular analysis.

Aqueous compositions that maintains fidelity of the nucleic acid sequences of a biological specimen

The invention is directed to compositions and methods for stimulating, enhancing or modulating the immune system of a patient before or after infection by a pathogen, and in particular multidrug resistant (MDR) MTB and extremely drug resistant (XDR) MTB. Compositions of the invention contain non-naturally occurring antigens that generate an effective cellular and/or humoral immune response to MTB and/or antibodies that are specifically reactive to MTB antigens. The greater activity of the immune system generated by a vaccine of the invention increases generation of memory T cells that provide for a greater and/or extended response to an MTB infection. Responses involve an increased generation of antibodies that enhance immunity against MTB infection and promote an enhanced phagocytic response. Monoclonal antibodies produced by the non-naturally occurring antigens enhance phagocytosis and killing of mycobacteria by phagocytic cells, enhance clearance of MTB from the blood and modulate immunity and cytokine responses.

Antibodies that modulate immunity to drug resistant and latent MTB infections

The invention relates to composite antigens comprising a peptide with contiguous amino acid sequence derived from a plurality of antigenic epitopes of one or more pathogens that induces an immune response in a mammal that is protective against infection by the one or more pathogens. In addition, the invention relates to vaccines comprising composite antigens and to method for treating and preventing an infection.

Methods of treating and preventing influenza infections

The invention is directed to compositions and methods for stimulating, enhancing or modulating the immune system of a patient before or after infection by a pathogen, and in particular MTB. Compositions of the invention contain non-naturally occurring antigens that generate an effective cellular and/or humoral immune response to MTB and/or antibodies that are specifically reactive to MTB antigens. The greater activity of the immune system generated by a vaccine of the invention increases generation of memory T cells that provide for a greater and/or extended response to an MTB infection. Responses involve an increased generation of antibodies that enhance immunity against MTB infection and promote an enhanced phagocytic response. Monoclonal antibodies produced by the non-naturally occurring antigens enhance phagocytosis and killing of mycobacteria by phagocytic cells, enhance clearance of MTB from the blood and modulate immunity and cytokine responses.

Monoclonal antibodies that modulate immunity to MTB and enhance immune clearance

The invention is directed to compositions and methods for rapidly and efficiently extracting nucleic acids and/or targeted nucleic acids sequences from biological samples. The methods of the invention comprise combining the sample with a buffer and magnetic silicon beads and concentrating the beads with a magnet or other electrical field. Liquid may be removed, or not, and an alkaline buffer is added followed by magnetic carboxy beads in a binding buffer so that nucleic acids transfer to the carboxy beads, which can be easily and quickly isolated once again with a magnet. Total nucleic acid extraction is greatly enhanced. Extracted nucleic acids can be analyzed, for example, by PCR wherein the nucleic acids can be identified and characterized. Carboxy beads may also contain a ligand so as to target specific nucleic acid sequences. The invention is also directed to kits comprising the tools and compositions for performing the methods of the invention.

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San Antonio, TX, United States of America

Luke T Daum