Abstract: Provided are novel vaccines for prophylactic treatment of SARS-CoV-2 infections and COVID-19 and methods of making the vaccines.

Abstract: The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Abstract: The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Abstract: The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Abstract: The present disclosure provides, among other things, a single-dose vaccine composition that includes a chitosan adjuvant and HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82, where the single-dose vaccine composition provides enhanced or comparable HPV vaccine response in comparison to a similar multiple-dose vaccine formulated without such chitosan adjuvant.

Abstract: The present invention is directed to antigen binding proteins including, but not limited to, monoclonal antibodies and antigen binding fragments thereof, that specifically bind to and preferably neutralize human cytomegalovirus (CMV). The antigen binding proteins of the invention are useful as a prophylactic and/or therapeutic agent for preventing and/or treating CMV infections in a patient in need thereof. Also encompassed by the invention are pharmaceutical compositions comprising the antigen binding proteins of the invention and a pharmaceutically acceptable carrier. The invention further relates to methods of using the antigen binding proteins and pharmaceutical compositions of the invention for the prevention or treatment of CMV infection in patients in need thereof.

Abstract: The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Abstract: A supercritical extractor system may include extractor chambers coupled to a supercritical fluid pump and configured to receive a matrix for an extraction process and a supercritical fluid from the supercritical fluid pump, and evaporator chambers coupled to the extractor chambers and configured to output an extractant from the matrix. Each evaporator chamber may include a body defining a cavity, a cone within the cavity, and arms coupled between an inner surface of the body and the cone. The supercritical extractor system may include a condenser coupled between the evaporator chambers and the supercritical fluid reservoir, and a controller coupled to the supercritical fluid pump, the extractor chambers, and the evaporator chambers and configured to monitor a characteristic during the extraction process.

Abstract: The present invention is directed to antigen binding proteins including, but not limited to, monoclonal antibodies and antigen binding fragments thereof, that specifically bind to and preferably neutralize human cytomegalovirus (CMV). Also encompassed by the invention are antigen binding proteins that have been humanized. The antigen binding proteins of the invention are useful as a therapeutic agent for treating and/or preventing CMV infections in a patient in need thereof.

Abstract: The present invention relates to methods of inducing an immune response to cytomegalovirus (CMV) using a genetically modified CMV that is conditionally replication defective. The methods of the invention can be used to treat and/or prevent primary CMV infection, infection due to reactivation of a latent CMV and a super-infection of a different strain of CMV that had been previously encountered. The present invention also relates to a replication defective CMV which has been recombinantly altered to allow for external control of viral replication. Compositions comprising the replication defective CMV are also encompassed by the present invention.

Abstract: The present invention is directed to antigen binding proteins including, but not limited to, monoclonal antibodies and antigen binding fragments thereof, that specifically bind to and preferably neutralize human cytomegalovirus (CMV). Also encompassed by the invention are antigen binding proteins that have been humanized. The antigen binding proteins of the invention are useful as a therapeutic agent for treating and/or preventing CMV infections in a patient in need thereof.

Abstract: The present invention relates to a cytomegalovirus (CMV) which has been recombinantly altered to express a heterologous polypeptide and to allow for external control of viral replication. The heterologous polypeptide may be a polypeptide of interest such as an antigen, antibody or immune modulator. The CMV vectors of the invention are replication defective, or chemically controllable replication capable, or replication competent. The present invention also relates to uses of the CMV vectors such as inducing an immune response to an antigen or expressing an antibody or immune modulator in vivo. Compositions comprising the CMV expressing the heterologous polypeptide are also encompassed by the present invention.

Abstract: The present invention relates to methods of inducing an immune response to cytomegalovirus (CMV) using a genetically modified CMV that is conditionally replication defective. The methods of the invention can be used to treat and/or prevent primary CMV infection, infection due to reactivation of a latent CMV and a super-infection of a different strain of CMV that had been previously encountered. The present invention also relates to a replication defective CMV which has been recombinantly altered to allow for external control of viral replication. Compositions comprising the replication defective CMV are also encompassed by the present invention.

Abstract: The present invention features PD-1 binding proteins, a subset of which inhibits binding of PD-L1 to the PD-1 receptor. These binding proteins can be employed to modulate the immune system through the manipulation of the PD-1 signaling pathway, enhancing host immunity to treat infections and cancer.

Abstract: The present invention relates to compositions and methods to elicit or enhance cell-mediated immunity against HCMV infection by providing polynucleotides encoding variant HCMV pp65, IE1, and IE2 proteins, and fusion proteins thereof. The present invention also provides recombinant vectors including, but not limited to, adenovirus and plasmid vectors comprising said polynucleotides and host cells comprising said recombinant vectors. Also provided herein are purified forms of the variant HCMV pp65, IE1, and IE2 proteins described herein, and fusion proteins. The variant HCMV proteins, and fusion proteins thereof, are useful as vaccines for the protection from and/or treatment of HCMV infection. Said vaccines are useful as a monotherapy or a part of a therapeutic regime, said regime comprising administration of a second vaccine such as a polynucleotide, cell-based, protein or peptide-based vaccine.

Abstract: The present invention features PD-1 binding proteins, a subset of which inhibits binding of PD-L1 to the PD-1 receptor. These binding proteins can be employed to modulate the immune system through the manipulation of the PD-1 signaling pathway, enhancing host immunity to treat infections and cancer.

Abstract: An efficient means of inducing an immune response against human immunodeficiency virus (HIV) utilizing specific prime-boost regimes is disclosed. The specific prime-boost regimes employ a heterologous prime-boost protocol employing recombinant adenoviral vectors of alternative and distinct serotypes comprising exogenous genetic material encoding a common HIV antigen. Vaccines administered into living vertebrate tissue in accordance with the disclosed regimes, preferably a mammalian host, such as a human or a non-human mammal of commercial or domestic veterinary importance, express the HIV-1 antigen (e.g., Gag), inducing a cellular immune response which specifically recognizes HIV-1. It is believed that the disclosed prime/boost regime will offer a prophylactic advantage to previously uninfected individuals and/or provide a therapeutic effect by reducing viral load levels within an infected individual, thus prolonging the asymptomatic phase of HIV-1 infection.

Abstract: Pharmaceutical compositions which comprise HIV Pol DNA vaccines are disclosed, along with the production and use of these DNA vaccines. The pol-based DNA vaccines of the invention are administered directly introduced into living vertebrate tissue, preferably humans, and preferably express inactivated versions of the HIV Pol protein devoid of protease, reverse transcriptase activity, RNase H activity and integrase activity, inducing a cellular immune response which specifically recognizes human immunodeficiency virus-1 (HIV-1). The DNA molecules which comprise the open reading frame of these DNA vaccines are synthetic DNA molecules encoding codon optimized HIV-1 Pol and codon optimized inactive derivatives of optimized HIV-1 Pol, including DNA molecules which encode inactive Pol proteins which comprise an amino terminal leader peptide.

Abstract: Pharmaceutical compositions which comprise HIV Nef DNA vaccines are disclosed, along with the production and use of these DNA vaccines. The nef-based DNA vaccines of the invention are administered directly introduced into living vertebrate tissue, preferably humans, and express the HIV Nef protein or biologically relevant portions thereof, inducing a cellular immune response which specifically recognizes human immunodeficiency virus-1 (HIV-1). The DNA molecules which comprise the open reading frame of these DNA vaccines are synthetic DNA molecules encoding codon optimized HIV-1 Nef and derivatives of optimized HIV-1 Nef, including nef modifications comprising amino terminal leader peptides, removal of the amino terminal myristylation site, and/or modification of the Nef dileucine motif. These modifications may effect wild type characteristics of Nef, such as myristylation and down regulation of host CD4.

Abstract: An efficient means of inducing an immune response against human immunodeficiency virus (“HIV”) utilizing specific prime-boost regimes is disclosed. The specific prime-boost regimes employ a heterologous prime-boost protocol wherein recombinant adenoviral and poxvirus vectors comprising exogenous genetic material encoding a common HIV antigen are administered in that order. Vaccines administered into living vertebrate tissue in accordance with the disclosed regimes, preferably a mammalian host such as a human or a non-human mammal of commercial or domestic veterinary importance, express the HIV-1 antigen (e.g., Gag), inducing a cellular immune response which specifically recognizes HIV-1. It is believed that the disclosed prime/boost regime will offer a prophylactic advantage to previously uninfected individuals and/or provide a therapeutic effect by reducing viral load levels within an infected individual, thus prolonging the asymptomatic phase of HIV-1 infection.