Abstract: The present invention relates to an expression cassette allowing expression of a functional LRIT3 protein in mammal eyes; said expression cassette is inserted in an expression vector, preferably an adeno-associated virus (AAV); accordingly, the present invention further relates to a recombinant adeno-associated virus (AAV) vector carrying a nucleic acid sequence encoding a normal LRIT3 gene, or fragment thereof, under the control of regulatory sequences which express the product of the gene in the ocular cells, a pharmaceutically acceptable composition comprising such a recombinant AAV vector and to its use for the treatment of congenital stationary night blindness

Abstract: The present disclosure provides T cell receptor (TCR) fusion proteins comprising a TCR that binds to a GVYDGREHTV (SEQ ID NO:34) HLA-A*02 complex that is covalently linked to a T cell engaging domain that binds a protein expressed on a cell surface of a T cell and an antibody Fc domain, as well as polynucleotides, vectors, kits, host cells, pharmaceutical compositions, methods, and uses related thereto.

Abstract: The instant invention provides binding proteins (“CD38-binding proteins”) which each comprise (1) a CD38-binding region for cell-targeting and (2) a Shiga toxin A Subunit effector polypeptide (“Shiga toxin effector polypeptide”). The Shiga toxin effector polypeptide components of the CD38-binding proteins may comprise a combination of mutations relative to a wild-type Shiga toxin sequence providing (1) de-immunization and/or (2) a reduction in protease sensitivity; wherein each Shiga toxin effector polypeptide retains one or more Shiga toxin function, such as, e.g., stimulating cellular internalization, directing intracellular routing, catalytic activity, and/or potent cytotoxicity. The CD38-binding proteins may have one or multiple uses, e.g., the selective killing of a specific CD38-expressing cell-type; and more generally, for the diagnosis and treatment of cancers and disorders involving CD38-expressing cells, e.g., in CD38-positive hematopoietic cancers such as multiple myeloma.

Abstract: CD93 functional domains for use in treating osteoporosis. A method of alleviating, reducing, suppressing, and/or treating an osteoclast-related bone disease is disclosed. The method comprises administering a therapeutically effective amount of an isolated recombinant protein comprising an amino acid sequence that is at least 80% identical to human Cluster of Differentiation 93 protein domain 1 to a subject in need thereof, the recombinant protein lacking amino acid residues 1 to 21, transmembrane and cytoplasmic domains of the human CD93 (SEQ ID NO: 3) and having a total length of no more than 559 amino acid residues. In one embodiment, the osteoclast-related bone disease is at least one selected from the group consisting of osteoporosis, postmenopausal osteoporosis, osteopenia, bone loss, inflammatory bone loss, and any combination thereof. In another embodiment, the recombinant protein comprises the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2.

Abstract: The present invention relates to a chimeric receptor capable of signaling both a primary and a co-stimulatory pathway, thus allowing activation of the co-stimulatory pathway without binding to the natural ligand. The cytoplasmic domain of the receptor contains a portion of the 4-1BB signaling domain. Embodiments of the invention relate to polynucleotides that encode the receptor, vectors and host cells encoding a chimeric receptor, particularly including T cells and natural killer (NK) cells and methods of use.

Abstract: The present invention relates to a peptide for reducing pathogen adhesion. Specifically, a peptide comprising an amino acid sequence having at least 75% sequence identity to SEQ ID NO: 1. The peptide also comprises at least one staple between two or more residues equivalent to residues 3, 7, 10 or 14 of SEQ ID NO: 1.

Abstract: The present invention provides improved LAMP Constructs comprising specific fragments of the LAMP lumenal domain to deliver antigens to immune cells for enhanced processing. These LAMP Constructs can be used for the treatment of disease and in particular, allergies, infectious disease, diabetes, hyperproliferative disorders and/or cancer. The improved LAMP Constructs allow for presentation of properly configured three dimensional epitopes for production of an immune response when administered to a subject. The improved LAMP Constructs can be multivalent molecules, and/or can be provided as part of a multivalent vaccine containing two or more LAMP Constructs. The improved LAMP Constructs as described herein can also be used to generate antibodies when administered to a non-human vertebrate.

Abstract: An active form (BY-001) of a homomultimeric chimeric protein PD-L1/Fc-gamma1 may have a composition of 25% dimer, 30% tetramer and 45% hexamer. BY-001 consists of two distinct functional domains at the aggregated state, one is the extracellular domain of PD-L1 and another one is the IgG1 Fc region. Accordingly, the first functional domain of PD-L1 at its aggregated state is more effective in suppressing the activity of CD3+ and CD28+ T cells; while, on the other hand, the second functional domain of FC-gamma1 at its aggregated state exerts only the suppressive effects on the immune cell bearing the Fc-gamma receptors. Thus, the features provided in present invention indicate that BY-001 regulates the functions of immune cells subsets that are responsible for the peripheral immune tolerance, which makes BY-001 potential to help restore or maintain the peripheral immune tolerance in patients with autoimmune diseases or in recipients of allografts.

Abstract: Provided herein are compositions and methods comprising non-naturally occurring nucleic acid sequences that encode biologics. Also provided are methods of utilizing the provided compositions and methods as ocular therapeutics for prevention and treatment of various diseases and conditions.

Abstract: The methods and compositions described herein address the need in the art by providing peptides and polypeptides comprising a growth factor binding domain. In some embodiments, the peptides have an amino acid sequence that is at least 80% identical to one of SEQ ID NOS:1-7, 13-15, 49-50, or 66-70, or a fragment thereof; wherein the peptide is less than 300 amino acids in length.

Abstract: The present invention provides a method for providing alpha-1 antitrypsin (?1-AT) to a subject, in particular a method for treating or preventing a disorder of disease associated with ?1-AT deficiency in the subject, wherein the method comprises providing, subcutaneously, a therapeutically or prophylactically effective amount of ?1-AT to the subject. Also provided is a composition and article of manufacture comprising ?1-AT, in particular a formulation suitable for subcutaneous administration of ?1-AT.

Abstract: The present disclosure provides, inter alia, engineered microbes expressing one or more therapeutic proteins from a nucleotide sequence chromosomally integrated, which is effective to treat or ameliorate a disease or disorder, e.g., a skin disease. In certain embodiments, composition, methods, and kits are provided comprising microbes expressing one or more therapeutic proteins from a chromosomally integrated nucleotide sequence.

Abstract: Provided herein are methods of determining the reduction susceptibility of a protein and methods of adjusting the culturing condition of the protein based on the reduction susceptibility.

Abstract: In one aspect, the present invention provides heterodimeric antibodies comprising a first monomer comprising a first heavy chain constant domain comprising a first variant Fc domain and a first antigen binding domain and a second monomer comprising a second heavy chain constant domain comprising a second variant Fc domain and a second antigen binding domain. In an additional aspect the heterodimeric antibody comprises a first monomer comprising a heavy chain comprising a first Fc domain and a single chain Fv region (scFv) that binds a first antigen, wherein the scFv comprises a charged scFv linker. The heterodimeric antibody further comprises a second monomer comprising a first heavy chain comprising a second Fc domain and a first variable heavy chain and a first light chain.

Abstract: The present disclosure relates to pharmaceutical compositions that comprise an antibody that neutralizes infection of hepatitis B virus (HBV). In addition, the present disclosure relates to the use of the pharmaceutical compositions in the treatment of HBV infection.

Abstract: The invention relates to an anti-viral composition comprising at least one, and ideally a plurality of, monoclonal antibodies, or fragments thereof; an immunogenic agent, vaccine or pharmaceutical composition comprising the afore anti-viral composition; said anti-viral composition, immunogenic agent, vaccine or said pharmaceutical composition for use in the treatment of or prevention of a viral infection; use of said anti-viral composition in the manufacture of a medicament to treat or prevent a viral infection; a combination therapeutic for use in the treatment or prevention of a viral infection comprising said anti-viral composition, immunogenic agent, vaccine or pharmaceutical composition in combination with at least one other therapeutic agent; and a method of treating or preventing a viral infection comprising administering said anti-viral composition, immunogenic agent, vaccine or said pharmaceutical composition to an individual having, or suspected of having, a viral infection.

Abstract: The present invention provides a rabies virus monoclonal antibody 2F2 and universal rabies virus antibody rapid detection test paper and belongs to the technical field of biological detection. An amino acid sequence of the monoclonal antibody 2F2 is shown as SEQ ID No. 1. The monoclonal antibody 2F2 provided by the present invention specifically binds to rabies virus G proteins, and preparation of the monoclonal antibody 2F2 into test paper has the advantages of rapidity, accuracy, sensitivity, specificity and low cost.

Abstract: The present disclosure provides antibodies and antigen-binding fragments thereof that specifically bind to the spike protein of SARS-CoV-2 and methods of using such antibodies and antigen-binding fragments thereof for the prevention and treatment of Coronavirus Disease 2019 (COVID-19) in a subject.

Abstract: The instant disclosure provides antibodies and antigen-binding fragments thereof that can bind to an influenza virus neuraminidase (NA) and can neutralize an influenza virus infection. Also provided are polynucleotides that encode an antibody, vectors that comprise such polynucleotides, host cells that can express the antibodies, related compositions, and methods of using the herein disclosed compositions to, for example, treat or prevent an influenza infection.

Abstract: Compositions and methods for the detection of Bordetella pertussis and diagnosing pertussis are disclosed.

Abstract: The present invention provides a novel antibody fragment based antifungal conjugate selectively targeting Candida spp. comprising of at least one antimicrobial peptide at one end of the conjugate, more particularly, human Histatin-5; an antibody fragment at the other end of the conjugate, specific against Candida spp. enolase, a virulence factor protease and biofilm specific antigen of Candida spp.; at least one signal protease cleavage sequence susceptible to cleavage by virulent protease secreted by Candida spp., secreted aspartyl proteinase-1 (SAP1); and at least one flexible polypeptide linker. The signal protease cleavage sequence and the flexible polypeptide linker are in tandem with each other and placed in between the antimicrobial peptide and the antibody. The in vitro MIC-99 of the conjugate against Candida spp., is in the range of 0.2-0.3 ?M, more specifically, 0.25 ?M or 250 nM.

Abstract: The present invention relates to a new composition of human recombinant antibody fragments in both single chain or Fab format, which is capable of completely neutralizing the venom of the scorpion Centruroides sculpturatus Ewing (C. sculpturatus. In particular the new composition comprises the scFv fragment 10FG2 (SEQ. ID. No: 1), which has broad cross-reactivity against various Mexican scorpion venom toxins, and the scFv fragment LR (SEQ. ID. No: 2), with more limited cross-reactivity. Alternatively, the new composition comprises the Fab 10FG2 fragment (SEQ. ID. No: 3 and SEQ.ID. No:4) and the Fab LR fragment (SEQ. ID. No: 5 and SEQ.ID. No 6). The two antibody fragments recognize independent epitopes, present in the two main toxins of the scorpion C. sculpturatus, so that they do not interfere with each other during their binding to the same, on the contrary the antibody fragments of the present invention complement the neutralizing activity.

Abstract: The present invention relates to methods for the preventive treatment of migraine in a subject comprising administering to said subject that does not exhibit signs of allodynia and/or hyperalgesia at least twenty-four hours into the post-ictal phase, an anti-PACAP agent.

Abstract: Provided are methods for clinical treatment of complement-mediated TMA (CM-TMA) (e.g., CM-TMA associated with a trigger, such as autoimmune condition, an infection, a transplant, one or more drugs, or malignant hypertension), using an anti-C5 antibody, or antigen binding fragment thereof, such as ravulizumab (ULTOMIRIS®).

Abstract: The present invention provides methods for treating an allergy by administering one or more antibodies that bind specifically to the allergen. In certain embodiments, the antibodies useful for treating an allergen, bind specifically to the cat allergen, Fel d1. According to certain embodiments of the invention, the antibodies are fully human antibodies that bind to Fel d1. The antibodies of the invention are useful for binding to the Fel d1 allergen in vivo, thus preventing binding of the Fel d1 allergen to pre-formed IgE on the surface of mast cells or basophils. In doing so, the antibodies act to prevent the release of histamine and other inflammatory mediators from mast cells and/or basophils, thus ameliorating the untoward response to the cat allergen in sensitized individuals.

Abstract: Provided herein are processes for manufacturing recombinant ranibizumab or a ranibizumab variant that include providing a liquid comprising recombinant ranibizumab or a ranibizumab variant that is substantially free of cells; capturing the recombinant ranibizumab or the ranibizumab variant in the liquid using an affinity chromatography column, wherein the eluate of the affinity chromatography column comprises the recombinant ranibizumab or the ranibizumab variant; purifying the recombinant ranibizumab or the ranibizumab variant in the eluate of step (b) using a first cation exchange chromatography column and buffers that have a pH of about pH 5.5 to about 7.

Abstract: An anti-ANGPTL3 antibody or an antigen-binding fragment thereof. The present invention provides an anti-ANGPTL3 antibody or an antigen-binding fragment thereof, wherein a heavy chain variable region includes complementarity determining regions (CDRs), including CDR-H1 having an amino acid sequence as set forth in SEQ ID No. 1, CDR-H2 having an amino acid sequence as set forth in SEQ ID No. 2, and CDR-H3 having an amino acid sequence as set forth in SEQ ID No. 3; and the CDRs of a light chain variable region includes CDR-L1 having an amino acid sequence as set forth in SEQ ID No. 4, CDR-L2 having an amino acid sequence as set forth in SEQ ID No. 5, and CDR-L3 having an amino acid sequence as set forth in SEQ ID No. 6. The antibody or the antigen-binding fragment thereof provided in the present invention can specifically recognize ANGPTL3.

Abstract: The present disclosure provides gene therapy expression constructs comprising a nucleic acid encoding a therapeutic anti-TNFalpha antibody (e.g., a monoclonal antibody) or an antigen binding fragment thereof, delivery vectors (e.g., viral vectors) comprising the same, compositions comprising the same, and methods of using the same (e.g., to treat ocular diseases or disorders). Some aspects of the disclosure are directed to a recombinant adeno-viral vector (rAAV) delivery comprising an AAV particle (e.g., AAV2) and a nucleic acid encoding a therapeutic anti-TNFalpha antibody (e.g., a monoclonal antibody) or an antigen binding fragment thereof.

Abstract: Methods of modulating IL-10 signaling in a diabetic patient are provided. The methods include administering a therapeutically effective amount of an agent that inhibits Interleukin-10 (IL-10) signaling to a wound site. The agent may antagonize IL-10 or IL-10R to inhibit IL-10 signaling. In some aspects the agent is an antibody or antigen-binding fragment that specifically binds to IL-10 or IL-10R.

Abstract: The invention provides interleukin-33 (IL-33) antibodies and methods of making and using the same, e.g., for treatment of IL-33 mediated disorders (e.g., ocular disorders such as AMD (e.g., geographic atrophy (GA)).

Abstract: Described herein are engineered anti-IL-2 antibodies with modified amino acid sequences. The engineered antibodies would confer modified receptor binding specificity to an IL-2-anti-IL2 antibody complex, inhibiting the binding of IL-2 to CD25. The engineered anti-IL-2 antibodies would facilitate expansion of subsets of effector immune cells and decrease undesirable effects caused by IL-2. Thus, the engineered anti-IL-2 antibodies would be useful in treating disease such as cancer and infection.

Abstract: The invention relates to antibodies such as anti-C1 s antibodies, pharmaceutical compositions comprising the same, and methods of using the same. The invention provides antibodies that comprise an antigen-binding region and an antibody constant region, have a displacement function such that the antibody binds to C1qrs complex and promotes dissociation of C1q from C1qrs complex and/or a blocking function such that the antibody binds to C1r2s2 and inhibits the binding of C1q to C1r2s2, and bind to C1s in a pH-dependent manner. The invention also provides pharmaceutical compositions comprising any one of the antibodies, and methods of treating an individual having a complement-mediated disease or disorder, or preventing an individual potentially having a complement-mediated disease or disorder, comprising administering any one of the antibodies to the individual.

Abstract: A bispecific antibody including a first domain which specifically binds to a mutant calreticulin protein and a second domain which specifically binds to a CD3 antigen. A pharmaceutical composition including the bispecific antibody or a functional fragment thereof. A diagnostic method for a myeloproliferative neoplasm, including detecting a polypeptide in a biological sample with the bispecific antibody.

Abstract: Provided are a molecule specifically binding to CLDN18.2, the molecule comprising an immunoglobulin single variable domain, a nucleic acid molecule encoding the molecule specifically binding to CLDN18.2, and an expression vector and a host cell for expressing the molecule specifically binding to CLDN18.2; further provided are a method for producing the molecule specifically binding to CLDN18.2 and use thereof for treating or preventing conditions associated with CLDN18.2.

Abstract: The present invention relates to the field of bio-pharmaceuticals and provides an anti-CLDN18.2 antibody. Related preparation methods and related uses are described. The antibody of the present invention or related an antigen-binding fragment can specifically bind to CLDN18.2 with a strong binding capacity. After humanization, the antibody or the antigen-binding fragment has a strong ADCC effect and CDC activity and has good pharmaceutical prospects.

Abstract: The present disclosure relates to targeted degradation platform technology. For example, the present disclosure relates to bispecific binding agents for degrading endogenous proteins, whether membrane-associated or soluble, using the lysosome pathway. The disclosure also provides methods useful for producing such agents, nucleic acids encoding same, host cells genetically modified with the nucleic acids, as well as methods for modulating an activity of a cell and/or for the treatment of various disorders.

Abstract: Disclosed herein are compositions comprising a polypeptide with at least two domains, wherein the first domain is capable of binding CD3 and the second domain is capable of binding to a cancer cell. Also disclosed herein are methods of treating cancer in a subject, comprising: providing a composition comprising a polypeptide with at least two domains, wherein the first domain is capable of binding CD3 and the second domain is capable of binding to a cancer cell; and treating the cancer by administering a therapeutically effective dosage of the composition to the subject.

Abstract: The present disclosure provides, inter alia, chimeric nanobody compositions that selectively modulate the function of a target protein within a defined population of cells. Also provided are methods for treating diseases such as ion channelopathies.

Abstract: The present invention provides antibodies useful as therapeutics for treating and/or preventing diseases associated with cells expressing Claudin-6 (CLDN6), including tumor-related diseases such as ovarian cancer, lung cancer, gastric cancer, breast cancer, hepatic cancer, pancreatic cancer, skin cancer, malignant melanoma, head and neck cancer, sarcoma, bile duct cancer, cancer of the urinary bladder, kidney cancer, colon cancer, placental choriocarcinoma, cervical cancer, testicular cancer, and uterine cancer.

Abstract: The present invention relates to the field of bio-pharmaceuticals and, in particular, to an anti-Siglec-15 antibody or an antigen binding fragment thereof, a nucleic acid sequence encoding the anti-Siglec-15 antibody of the present invention or an antigen binding fragment thereof, an expression vector containing the nucleic acid sequence, a host cell containing the expression vector, a composition or a bispecific antibody comprising the anti-Siglec-15 antibody of the present invention or an antigen binding fragment thereof, an immune conjugate comprising the anti-Siglec-15 antibody of the present invention or an antigen binding fragment thereof linked to a therapeutic agent, as well as use of the anti-Siglec-15 antibody of the present invention or an antigen binding fragment thereof in the preparation of a medicament for treatment of cancer.

Abstract: The present invention relates bispecific antibodies and antigen binding fragments thereof for binding to CD33 and CD7 for use in treating CD33+ CD7+ hematological malignancies, and in particular Acute Myeloid Leukaemia (AML). In particular, the present invention relates to a bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the bispecific antibody or antigen binding fragments comprises: a first binding region binding to human CD33 which has a KD binding affinity to CD33 of between about 1.36×109 and about 9.23×10?8; and a second binding region binding to human CD7 which has a KD binding affinity to CD7 of between about 3.56×10?9 and about 5.41×10?7.

Abstract: Provided is a bispecific antibody, comprising a first antigen-binding moiety and a second antigen-binding moiety, wherein a paired domain of the first antigen-binding moiety comprises an amino acid sequence of engineered HLA-I ?3 and an amino acid sequence of engineered ?2M. Also provided are an expression method for the bispecific antibody, a polynucleotide encoding the bispecific antibody, a vector and host cell containing the polynucleotide, a pharmaceutical composition containing the bispecific antibody, a fusion protein, and a conjugate.

Abstract: Markers of acute myeloid leukemia stem cells (AMLSC) are identified. The markers are differentially expressed in comparison with normal counterpart cells, and are useful as diagnostic and therapeutic targets.

Abstract: A polypeptide having a heavy chain variable region and/or light chain variable region that specifically binds to Ror2 protein as well as antibodies and antibody fragments containing the heavy chain variable region and/or the light chain variable region that bind to Ror2 protein. Pharmaceutical compositions and kits comprising the polypeptide or antibodies and antibody fragments containing the polypeptide are also provided.

Abstract: Provided herein are methods of treating cancer or infection, which comprise administering to a human patient in need thereof: (a) an anti-human PD-1 monoclonal antibody or antigen binding fragment thereof; (b) an anti-human LAG3 monoclonal antibody or antigen binding fragment thereof; and (c) an anti-human TIGIT monoclonal antibody or antigen binding fragment thereof. Also provided are pharmaceutical compositions and kits containing such agents for the treatment of cancer or infection.

Abstract: The present invention relates to a diluent for diluting a drug product, which comprises a multispecific hetero-dimeric immunoglobulin, to obtain a drug product ready for administration to a patient by infusion. In particular, the diluent of the present invention is such that the loss of antibody material is minimized.

Abstract: The present invention is based, in part, on the identification of novel biomarkers, and methods of modulate thereof, for sensitizing cancer cells to T cell-mediated killing.

Abstract: The present disclosure relates to systems for the expression of antibodies or antigen binding fragments in a subject, as well as methods of treatments of diseases therewith.

Abstract: The present invention provides bispecific antigen-binding molecules having a monovalent arm specific to a first target antigen (e.g., a T cell antigen, such as CD3) and a bivalent arm specific for a second target antigen (e.g., a tumor antigen, such as HER2). Bispecific antigen-binding molecules are useful in the treatment of disorders, such as cancer (e.g., HER2-positive cancer). The invention also features methods of producing bispecific antigen-binding molecules, methods of treating disorders using bispecific antigen-binding molecules, and compositions including bispecific antigen-binding molecules.

Abstract: The present application relates to antibodies specifically binding to the V-domain immunoglobulin-containing suppressor of T-cell activation (VISTA) at acidic pH and their use in cancer treatment. In some embodiments, the antibodies bind specifically to human VISTA at acidic pH, but do not significantly bind to human VISTA at neutral or physiological pH.