The disclosure provided herein relates to the field of radioimmunoconjugates, specifically the radiolabeling of immunoconjugates with Actinium-225 (225AC) for therapeutic and diagnostic applications. The disclosure encompasses improved methods for producing radioimmunoconjugates, including streamlined processes that eliminate intermediate purification steps, optimize radiochemical yield and stability, and enable scalability for clinical and commercial manufacturing. The disclosure further encompasses compositions of radioimmunoconjugates, optimized reaction conditions, and scalable production methodologies designed to enhance efficiency, reduce production time, and ensure compliance with Good Manufacturing Practice (GMP) standards. Additionally, the disclosure provides pharmaceutical compositions comprising radioimmunoconjugates and methods of use for treating diseases such as cancer.
A61K 51/10 - Antibodies or immunoglobulinsFragments thereof
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
The present invention provides materials and methods for viral engineering, including the production of vectors and viral particles useful in, for example, gene therapy.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
RR)-N-(2-(4-(4-cyclopropylpiperazin-l-yl)piperidin-l -yl)-5-((6-(3-(3,5- difluorophenyl)isoxazolidin-2-yl)pyrimidin-4-yl)amino)-4-methoxyphenyl)acrylamide, or a pharmaceutically acceptable salt thereof, in combination with amivantamab.
Compositions and methods for specific expression of RNA or protein are provided, such as a Chimeric Antigen Receptor (CAR) or T Cell Receptor (TCR), in T cells, with limited or no expression in non-T cells.
A method of treating moderate to severe atopic dermatitis (AD) in a patient by administering a bi-specific, tetravalent IgG4 antibody that binds to both the IL4 receptor alpha IL-4Rα and IL-31, at an initial dose and subsequent doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Compositions and methods for the treatment of cancer, in particular prostate cancer, are described. According to certain embodiments, a method of treating cancer in a patient comprises administering to the patient a combination of a therapeutically effective amount of a bispecific antibody that bind to kallikrein related peptidase 2 (hK2) and cluster determinant 3 (CD3) and an antibody drug conjugate (ADC) targeting prostate specific membrane antigen (PSMA).
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
8.
MATERIALS, METHODS AND SYSTEMS FOR STIMULATING HOST IMMUNE RESPONSES
The present disclosure relates to inter alia novel designs, compositions, systems and formulations, etc. of nucleic acid(s) (polynucleotide or oligonucleotide, etc.) products, specifically compositions and formulations of nucleic acid immunity inducing agents, such as adjuvants, immunization and or vaccine products and accessory products and nucleic acid gene therapy products, and the like. The compositions of the disclosure enhance immunity, and provide nucleic acid based medicinal and pharmaceutical products. When introduced directly into a host, such as intradermal cells and or tissues, the embodiments described herein induces production of immune responses which specifically recognize targets, such as human targets.
Materials, methods, and systems are provided for proteins comprising a muscle fortifying agent and metabolic modulatory component. The muscle fortifying agent is, for example, a myostatin modulator or the like, an activin type II receptor modulator or the like, or any and each combination thereof. The metabolic component may be an anti-GIPR antibody or fragment thereof and a metabolic modulator. Exemplary metabolic modulators include GLP-1 receptor agonist. In one aspect, the present invention teaches and describes materials, methods, and systems of metabolic modulation, including modulatory agents. For example, the improved materials, methods, and systems of the present invention include novel agents that regulate metabolism in a host. Included are molecules that specifically bind to one or more than one molecule or target, including multispecific molecules, conjugates of a muscle fortifying agent, and for example an additional active metabolic component directly connected or joined via a linker. In particular, the invention includes conjugates or fusions or the like comprising a muscle fortifying agent in combination with a metabolic modulator, including for example a glucagon-like peptide-1 (GLP-1) receptor binding molecule, such as an agonist, and/or an antagonist of the glucose-dependent insulinotropic peptide receptor (GIPR), etc.; and includes nucleic acids and expression vectors encoding the conjugates, recombinant cells thereof, and compositions comprising the conjugates suitable for development and use in hosts. Materials and methods of producing the modulators and various uses are provided.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
10.
MATERIALS, METHODS, AND SYSTEMS FOR BIOLOGIC MOLECULE OCCUPANCY DETERMINATIONS
Materials, methods, means, steps and systems for determining occupancy of a multi-target agent at two or more targets in the same cell. The method generally includes use of multiple detection reagents to determine a bound condition of the multi-target agent to each of the multiple targets, respectively. Each detection reagent includes a detectable label and is designed to bind a specific region of the multi-target agent unique to the agent's ability to bind to one of the multiple targets on the cell surface, thus providing single bound signals. A total amount of the multi-target agent bound to the multiple targets is determined using a universal detection reagent designed to bind to a common region of the multi-target agent. Subtracting specific single bound signals from bound signals allows calculation of multiply bound signals and specific total signals. This approach allows for the measurement of target occupancy for each bound condition with each target.
G01N 33/558 - ImmunoassayBiospecific binding assayMaterials therefor using diffusion or migration of antigen or antibody
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
11.
METHODS OF TREATING SMOLDERING MULTIPLE MYELOMA WITH CILTACABTAGENE AUTOLEUCEL
Provided herein are methods of treating smoldering multiple myeloma in a subject in need thereof. In some embodiments, the method comprises administering ciltacabtagene autoleucel. In some embodiments, the method comprises administering ciltacabtagene autoleucel to a subject, wherein the subject achieves minimum residual disease (MRD) negative status by about 28 days after administration of ciltacabtagene autoleucel.
Embodiments described herein relate to methods of treating multiple myeloma in a subject in need thereof, comprising administering a therapeutically effective amount of a BCMA x GPRC5D x CD3 trispecific antibody or trispecific binding fragment thereof, and pomalidomide, to the subject to treat the multiple myeloma.
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 35/02 - Antineoplastic agents specific for leukemia
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
13.
COMBINATION OF TRISPECIFIC ANTIBODY TARGETING BCMA, GPRC5D AND CD3, AND AN ANTI-CD38 ANTIBODY FOR THE TREATMENT OF MULTIPLE MYELOMA
Embodiments disclosed herein relate to methods of treating multiple myeloma in a subject in need thereof, comprising administering a therapeutically effective amount of BCMA x GPRC5D x CD3 trispecific antibody or trispecific binding fragment thereof and an anti-CD38 antibody, to the subject to the subject to treat the multiple myeloma.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61P 35/02 - Antineoplastic agents specific for leukemia
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
14.
MATERIALS, METHODS, AND SYSTEMS FOR ENHANCED PROTEASE TARGETING
Materials, methods, and systems for enhanced protease targeting. For example, methods for the targeting of kallikrein related peptidase 2 (KLK2) are provided.
Methods of treating cancer of the digestive system, preferably of the gastrointestinal system, in a patient using an anti-GUCY2CxCD3 antibody are disclosed.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
The invention provides a model system for identifying biomarkers of lactate runaway, as well as a panel of biomarkers identified as being associated with lactate runaway. Also provided are methods of detecting or modulating the biomarkers at any stage of cell culture, and or upstream process development stages to control lactate runaway in cell culture.
Provided are methods relating to subjects that are receiving lazertinib in a dosage of 240 mg/day, in combination with a dosage of amivantamab, in order to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations in the subject.
Herein are methods of treating multiple myeloma in a subject comprising administering GPRC5D antibodies with enhanced antibody-dependent cellular cytotoxicity (ADCC) and enhanced complement-dependent cytotoxicity (CDC). The antibodies described in the methods are afucosylated and comprise K248E and T437R mutations (designated as "RE mutations") per the EU numbering system.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A method of treating psoriatic arthritis, comprises administering an IL-23 inhibitor, such as an anti-IL-23p19 antibody (e.g., guselkumab) and a TNF-α inhibitor, such as an anti-TNF-α antibody (e.g., golimumab).
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A61P 19/02 - Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
A61P 37/00 - Drugs for immunological or allergic disorders
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
21.
BISPECIFIC ANTIBODY TARGETING HK2 AND CD3 FOR THE TREATMENT OF PROSTATE CANCER
The present invention relates to methods of treating prostate cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a KLK2xCD3 bispecific antibody or bispecific binding fragment thereof to the subject to treat the prostate cancer.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
22.
METHODS FOR REDUCING INFUSION-RELATED REACTIONS IN PATIENTS TREATED WITH EGFR/MET BISPECIFIC ANTIBODIES
The present invention relates to methods of reducing occurrence or severity of infusion-related reactions (IRRs) in a subject treated with an anti-epidermal growth factor receptor (EGFR)/hepatocyte growth factor receptor (c-Met) antibody, comprising administering (a) dexamethasone; (b) montelukast; or (c) methotrexate to the subject.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 39/00 - Medicinal preparations containing antigens or antibodies
23.
METHODS FOR REDUCING DERMATOLOGIC ADVERSE EVENTS IN PATIENTS TREATED WITH EGFR/MET BISPECIFIC ANTIBODIES
The present invention relates to methods of reducing occurrence or severity of dermatologic adverse events (DAEs) in a subject treated with an anti-epidermal growth factor receptor (EGFR)/hepatocyte growth factor receptor (c-Met) antibody and EGFR tyrosine kinase inhibitor, comprising (a) administering an antibiotic(s); (b) administering an antiseptic(s); and (c) administering a non-comedogenic moisturizer to the subject.
Provided herein are methods of treating an autoimmune disease in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of an anti-BCMA therapeutic.
A61P 19/02 - Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
25.
METHODS AND COMPOSITIONS FOR MODULATING BETA CHAIN MEDIATED IMMUNITY
The present disclosure relates to bispecific molecules targeting V017 and DLLS, nucleic acids and expression vectors encoding said molecules, recombinant cells containing the vectors, and compositions comprising the molecules. Methods of making the antibodies, and methods of using the antibodies to kill cancer cells, are also provided.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
26.
DOSES AND PHARMACEUTICAL COMPOSITIONS OF A CD33 X Vδ2 BISPECIFIC ANTIBODY FOR THE TREATMENT OF CANCER
The present disclosure relates to doses and dosing regimens of a bispecific antibody that binds myeloid cell surface antigen CD33, and the Vδ2 chain of the human Vγ9Vδ2 T cell receptor; to pharmaceutical compositions comprising said antibodies, as well as methods of administration of the referred doses, and to the use of said antibodies in the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Neoplasms (MDS), in particular Relapsed or Refractory (R/R) AML or MDS.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Described herein are methods and compositions for treating high-risk smoldering multiple myeloma in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an anti-CD38 antibody.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
28.
DARATUMUMAB.BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE FOR TREATING MULTIPLE MYELOMA
A61K 31/454 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
The present invention relates to antibodies and antigen-binding fragments thereof that specifically bind to tumor necrosis factor (TNF) receptor 2 (TNFR2). The present invention also provides compositions and pharmaceutical compositions comprising the same, as well as methods of treatment and various other aspects.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61P 37/00 - Drugs for immunological or allergic disorders
30.
COMBINATION THERAPIES FOR THE TREATMENT OF COLORECTAL CANCER
Disclosed herein are methods of treating metastatic colorectal cancer (e.g., in the frontline setting) with a bispecific anti-EGFR/c-Met antibody and FOLFIRI or mFOLFOX6.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Disclosed herein are methods of treating metastatic colorectal cancer (e.g., in the second-line setting) with a bispecific anti-EGFR/c-Met antibody and FOLFIRI.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Disclosed herein are methods of using amivantamab in combination with carboplatin and pemetrexed for the treatment of non-small cell lung cancer (NSCLC).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
33.
METHODS OF TREATING ULCERATIVE COLITS WITH ANTI-IL23 SPECIFIC ANTIBODY
A method of treating ulcerative colits in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial subcutaneous dose and subsequent subcutaneous doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
A61P 1/00 - Drugs for disorders of the alimentary tract or the digestive system
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A61K 39/00 - Medicinal preparations containing antigens or antibodies
34.
METHODS OF TREATING CROHN'S DISEASE WITH ANTI-IL23 SPECIFIC ANTIBODY
A method of treating Crohn's disease in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial subcutaneous dose and subsequent subcutaneous doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
35.
MATERIALS AND METHODS FOR IMPROVED THREE-DIMENSIONAL IMMUNITY
Provided are improved immunogenic compositions, such as those comprising a nanodisc. In some aspects the nanodisc comprises a membrane scaffold protein (MSP), a phospholipid, and an immunogen, wherein the membrane scaffold protein and the immunogen are from different species. Provided is a method of inducing an improved immune response in a subject, the method comprising administering to the subject the immunogenic composition, wherein the MSP is from or is derived from the same species as the subject. Provided is a system for inducing an immune response in a subject, comprising the immunogenic composition, wherein the MSP is from or is derived from the same species as the subject. Provided is a system for active immunization to prevent a disease in a subject, the system comprising the immunogenic composition, wherein the MSP is from or is derived from the same species as the subject. Preferably, MSP is not immunogenic to subject.
C07K 17/04 - Peptides being immobilised on, or in, an organic carrier entrapped within the carrier, e.g. gel, hollow fibre
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
An immunogenic composition that includes an adjuvant and a soluble protein. The adjuvant may be a nanoparticle, such as a zinc chitosan nanoparticle. The soluble protein may comprise a tag, such as a His tag. A method for inducing an immune response in a subject in need thereof, breaking an immune tolerance in a subject in need thereof, and/or for active immunization to prevent a disease in a subject by administering the immunogenic composition. A system for inducing an immune response in a subject in need thereof, breaking an immune tolerance in a subject in need thereof, and/or for active immunization to prevent a disease in a subject that includes the immunogenic composition and a delivery system.
The present invention relates to antibodies that bind to ENPP3 and antibody-drug conjugates comprising an antibody that binds to ENPP3 conjugated to a drug, such as an auristatin. Also provided herein are methods for treating a solid tumor or leukemia comprising administering such ADCs.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
38.
TREATMENT OF LOCALLY ADVANCED OR METASTATIC EGFR-MUTATED NON-SMALL CELL LUNG CANCER
Disclosed herein are methods of improving the safety and efficacy of a therapy comprising a bispecific epidermal growth factor receptor (EGFR)/ hepatocyte growth factor receptor (c-Met) antibody for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
C07K 14/00 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
39.
CHIMERIC ANTIGEN RECEPTOR WITH SPACER DOMAINS DERIVED FROM HUMAN IGG
The present disclosure is related to chimeric antigen receptors (CARs) comprising Immunoglobulin G (IgG) derived spacers, e.g., a human IgG hinge and a human IgG Fc derived CAR spacer. IgGl derived spacers confer improved properties to the CARs, e.g., increased cytokine release with respect to CARs not comprising IgG derived spacers. Also provided are cells expressing CARs comprising IgG derived spacers regions and methods to use the CARs to treat diseases or disorders, e.g., cancer.
Described herein are IL-18 variants, and fusion proteins comprising IL-18 variants and anti-PD-1 antibodies or a fragment thereof. Also described herein are methods of using fusion proteins to treat cancer and other conditions.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
Embodiments of the present invention relate to methods of treating multiple myeloma in a subject in need thereof comprising administering to the subject a BCMAxCD3 bispecific antibody on a novel dosing schedule.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Provided herein are multispecific antibodies, including bispecific antibodies that specifically bind to EMR2 and TRBV19 (also known as Vβ17), and monospecific antibodies that specifically bind to EMR2, and multispecific antigen-binding fragments thereof. Also described are related polynucleotides capable of encoding the provided multispecific antibodies or multispecific antigen-binding fragments, cells expressing the provided multispecific antibodies or multispecific antigen-binding fragments, as well as associated vectors and detectably labeled multispecific antibodies or multispecific antigen-binding fragments. In addition, methods of producing and using the provided multispecific antibodies and multispecific antigen-binding fragments are described.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61P 35/02 - Antineoplastic agents specific for leukemia
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
43.
COMPOSITIONS AND METHODS FOR THE TREATMENT OF PROSTATE CANCER
Compositions and methods for the treatment of cancer, in particular prostate cancer, are described. According to certain embodiments, a method of treating cancer in a patient comprises administering to the patient a therapeutically effective amount of a radioconjugate, wherein the radioconjugate comprises an antibody or antigen binding domain with binding specificity for hK2.
Provided herein are methods of treating cancer in a subject in need thereof. In some embodiments, the method comprises administering an anti-BCMA CAR-T cell and a GPRC5DxCD3 bispecific antibody. In some embodiments, the method comprises administering an anti-BMCA CAR-T cell, a GPRC5DxCD3 bispecific antibody, and a BCMAxCD3 bispecific antibody.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Provided herein are methods of treating cancer in a subject in need thereof by administering an anti-BCMA CAR-T cell and a GPRC5DxCD3 bispecific antibody. In some embodiments, the subject has relapsed and/or refractory multiple myeloma. In some embodiments, the subject has received at least one prior line of therapy. In some embodiments, the subject has newly diagnosed multiple myeloma and is transplant ineligible.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Provided is a serum-free, xeno-free, feeder-free method for selectively activating and expanding human γδ T cells to achieve sufficient cell numbers for adoptive cell therapy while retaining their robust intrinsic antitumor activity comprising: (a) contacting the γδ T cells with an isolated antibody or antigen-binding fragment that agonizes the γδ T cell receptor; (b) culturing the γδ T cells in cell culture medium comprising a cytokine selected from IL-2, IL-7, IL-12, IL-15, IL-18, IL-21, IL-22, IL-27, and TGFβ, and combinations thereof; wherein the cell culture medium further comprises a serum substitute In some embodiments, the γδ T cells are obtained from induced pluripotent stem cells (iPSCs) and/or peripheral blood mononuclear cells (PBMCs). In further embodiments, the γδ T cells express the Vγ9Vδ2 T cell receptor. The iPSC-derived γδ T cells or the PBMC-derived γδ T cells may be engineered to express a chimeric antigen receptor (CAR).
The application describes the first-in-human study on using a anti-KLK2xCD3 bispecific antibody and another anti-cancer drug, in particular, in particular a taxane chemotherapy or Androgen Receptor Pathway Inhibitor (ARPI), to provide enhanced antitumor efficacy with a deeper and more durable clinical response.
A61K 31/00 - Medicinal preparations containing organic active ingredients
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Provided herein are anti-LTßR multispecific binding molecules, nucleic acids encoding the anti- LTßR multispecific binding molecules, vectors comprising the nucleic acids, host cells comprising the vectors, and pharmaceutical compositions comprising the anti-LTßR multispecific binding molecules. Also provided are methods of treating cancer in a subject in need thereof, the methods comprising administering the pharmaceutical compositions disclosed herein.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Provided herein are anti-LTβR multispecific binding molecules, nucleic acids encoding the anti-LTβR multispecific binding molecules, vectors comprising the nucleic acids, host cells comprising the vectors, and pharmaceutical compositions comprising the anti-LTβR multispecific binding molecules. Also provided are methods of treating cancer in a subject in need thereof, the methods comprising administering the pharmaceutical compositions disclosed herein.
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
50.
MATERIALS, METHODS AND SYSTEMS FOR CELLULAR REDIFFERENTIATION AND EXPANSION
Materials, methods, and systems for the cellular redifferentiation and expansion of γδ T cells from induced pluripotent stem cell (iPSC)-derived hematopoietic stem cells (iHSCs) without the use of serum or additional cells is provided.
The disclosure provides a method of predicting a response to a treatment regimen for psoriasis in a subject. Biomarkers and clinical variables that can be used to predict the response and to select a treatment regimen are described herein. Also described is a kit for predicting a response to a treatment regimen for psoriasis in a subject.
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
52.
METHODS OF TREATING CROHN'S DISEASE WITH ANTI-IL23 SPECIFIC ANTIBODY
A method of treating Crohn's disease in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial intravenous dose and subsequent subcutaneous doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A61P 1/00 - Drugs for disorders of the alimentary tract or the digestive system
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
53.
USE OF BISPECIFIC ANTI-EGFR/C-MET ANTIBODIES TO TREAT SOLID TUMORS
The present invention relates to methods of treating an epidermal growth factor receptor (EGFR)-expressing or hepatocyte growth factor receptor (c-Met)-expressing cancer in a subject in need thereof. The methods comprise administering to the subject a therapy comprising an isolated bispecific anti-EGFR/c-Met antibody, wherein the administration comprises a dose administered once per a 28-day cycle.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Provided herein are methods of treating a subject who has multiple myeloma and has received one to three prior treatment(s). Infusions of chimeric antigen receptor (CAR)-T cells comprising a CAR capable of specifically binding to an epitope of BCMA are administered to the subject.
Provided herein are methods of treatment comprising administering oncolytic viruses comprising payload genes, such as genes encoding IL-12, FLT3L, CD40 agonists, and/or CTLA- 4 antibodies and antibodies to immunomodulatory agents.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Provided herein are methods for treating cancer in an individual comprising administering an oncolytic virus in combination with a PD-1 antibody. The provided methods trigger an abscopal response in distant tumors, facilitating the systemic activation of the immune system to identify and target untreated tumor sites. By harnessing the dual mechanisms of oncolytic viruses and immune checkpoint inhibition, the methods provided herein enhance overall treatment efficacy, offering a novel approach to the treatment of various types of malignancies.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A method for determining the affinity of an antibody to a cell-surface antigen. The method generally includes incubating the antibody with the cell-surface antigen and separating free antibody in solution from antibody that is bound to the cell-surface antigen. The free antibody in solution may then be added to a solid support having a fixed antigen and incubated. A labeled agent that binds to antibody that is bound to the fixed antigen is then added, and unbound label is removed. Electrochemiluminescence of the labeled agent that is bound to the antibody that is bound to the fixed antigen is then measured and that data is used to calculate a binding affinity of the antibody to the cell-surface antigen. The method may be implemented in high throughput format, may be automated and/or continuous, and further may be controlled by a central processor, for example a computer.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/60 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving labelled substances involving radioactive labelled substances
G01N 33/532 - Production of labelled immunochemicals
G01N 33/537 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
58.
ANTI-TRANSFERRIN RECEPTOR COMPOSITIONS AND METHODS THEREOF
The application describes anti-TfR antibodies and antigen-binding fragments thereof for delivering an agent to the brain of a subject in need thereof are described. Also described are conjugates and fusion constructs containing the anti-TfR antibody or antigen-binding fragment thereof coupled to a therapeutic or diagnostic agent, such as a second antibody and antigen- binding fragment thereof, for treating or detecting a neurological disorder and/or delivering a therapeutic or diagnostic agent across the blood-brain barrier. Also described are nucleic acids.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61P 25/28 - Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
59.
BCMA-TARGETED CAR-T CELL THERAPY FOR MULTIPLE MYELOMA
Provided herein are methods of treating a subject who has multiple myeloma and has received an initial therapy, including a stem cell transplantation. Infusions of chimeric antigen receptor (CAR)-T cells comprising a BCMA CAR comprising a polypeptide are administered to the subject. In certain embodiments, the dose of CAR-T cells administered to the subject is from 1.0 x 105to 5.0 x 106 of CAR-T cells per kilogram of the subject's mass. The method of treatment is effective in obtaining and maintaining minimal residual disease negativity status, as well as other beneficial clinical outcomes related to efficacy and safety.
A61K 31/454 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 40/11 - T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cellsLymphokine-activated killer [LAK] cells
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
Disclosed herein are methods and compositions for treating ovarian cancer. In some embodiments, the compositions comprise polynucleotides encoding polypeptides that are ovarian cancer neoantigen sequences. Also disclosed herein are methods of treating or preventing ovarian cancer in a subject, the methods comprising administering to the subject a treatment regimen comprising Ad26 vector comprising a polynucleotide encoding ovarian neoantigen sequences and self-replicating RNA molecule comprising a polynucleotide encoding ovarian neoantigen sequences.
The present invention relates to methods of treating head and neck squamous cell carcinoma (HNSCC), such as metastatic or advanced HNSCC, in a subject in need thereof, comprising administering a therapeutically effective amount of an antibody (e.g., a bispecific antibody) to the subject, wherein the antibody specifically binds epidermal growth factor receptor (EGFR) and hepatocyte growth factor receptor (c-Met).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
63.
PATCH ASSEMBLY CONFIGURED TO FACILITATE NEEDLE INSERTION INTO A PATIENT AND DELIVERY OF MEDICAMENT THROUGH THE NEEDLE, AND METHOD OF MAKING AND USING SAME
A patch assembly configured to facilitate needle insertion into a patient and delivery of medicament through the needle can include a body to contact a patient and a button movably attached to the body along a first axis. A carriage can be positioned within the body and configured to be rotated with respect to the body, and a needle can be fixed to and extend below a lower surface of the carriage. A needle guard can be movably attached to the body and configured to surround the needle. A needle guard biasing member can be positioned within the body and the needle guard, and can extend along a second axis that is perpendicular to the first axis. Application of a force to the button can be configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.
The present invention relates to methods of treating colorectal cancer (CRC), such as metastatic colorectal cancer (mCRC) or unresectable colorectal cancer, in a subject in need thereof, comprising administering a therapeutically effective amount of an antibody (e.g., a bispecific antibody) to the subject, wherein the antibody specifically binds epidermal growth factor receptor (EGFR) and hepatocyte growth factor receptor (c-Met).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
An injection aid can include a housing and an actuation assembly within the housing. The housing can be configured to receive a cartridge including a medicament chamber. The housing can include a lid assembly and a base assembly. The lid assembly can be pivotable with respect to the base assembly. The injection aid can include a carriage movably attached to an anchor by two springs extending therebetween. The actuation assembly can be configured to move a plunger relative to the medicament chamber to dispense medicament out of the medicament chamber.
Disclosed are methods of increasing transgene expression in a cell. The method can include providing a DNA vector comprising a Recognition Cassette (NUE-DNA vector), providing a nuclear uptake enhancer protein (NUE) for delivery into a cell and co-delivering the NUE-DNA vector and the NUE into the cell wherein co-delivering the NUE-DNA vector with the NUE increases transgene expression levels as compared to delivery of the NUE-DNA vector alone. The method can also include co-delivering a mRNA comprising a sequence encoding a NUE (NUE-mRNA) and a NUE-DNA vector into a cell wherein the co-delivery increases transgene expression levels as compared to delivery of the NUE-DNA vector alone. Constructs of NUEs are also provided.
C12N 15/67 - General methods for enhancing the expression
C07K 14/465 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from birds
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C12N 15/85 - Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
67.
TRISPECIFIC ANTIBODY TARGETING BCMA, GPRC5D AND CD3 FOR THE TREATMENT OF AL AMYLOIDOSIS
Embodiments of the present disclosure relate to methods of treating AL amyloidosis in a subject in need thereof, comprising administering a therapeutically effective amount of a BCMA x GPRC5D x CD3 trispecific antibody or trispecific binding fragment thereof, to the subject to the subject to treat the AL amyloidosis.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 40/11 - T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cellsLymphokine-activated killer [LAK] cells
Embodiments of the present disclosure relate to methods of treating multiple myeloma in a subject in need thereof, comprising administering a therapeutically effective amount of a BCMA x GPRC5D x CD3 trispecific antibody or trispecific binding fragment thereof, to the subject to the subject to treat the multiple myeloma.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 40/11 - T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cellsLymphokine-activated killer [LAK] cells
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
A method of selecting a therapeutic oligonucleotide for use in a therapeutic oligonucleotide targeting ligand drug conjugate, the method encompassing: linking one or more p19 polypeptides to a targeting ligand and contacting a therapeutic oligonucleotide to the targeted-p19 polypeptide to form a targeted-p19-oligonucleotide complex.
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C07K 16/00 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies
C12N 15/113 - Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides
C40B 40/06 - Libraries containing nucleotides or polynucleotides, or derivatives thereof
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
71.
GPRC5D ANTIBODIES WITH ENHANCED EFFECTOR FUNCTION AND USES THEREOF
Herein are antibodies or antigen-binding fragments specifically binding to GPRC5D. Additionally, monovalent antibodies or antigen-binding fragments specifically binding to GPRC5D are also included. The Fc region of these antibodies contains K248E and T437R mutations (designated as "RE mutations") per the EU numbering system. The described antibodies, expressed in host cells that lack fucosylation capabilities, exhibit enhanced antibody¬ dependent cellular cytotoxicity (ADCC) and enhanced complement-dependent cytotoxicity (CDC).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
CD33 antibodies, and antigen-binding fragments thereof, and CD33/Vδ2 multispecific antibodies, or antigen-binding fragments thereof, are described. Also described are polynucleotides encoding the antibodies, compositions comprising the antibodies, methods of producing the antibodies, and methods of using the antibodies for treating or preventing diseases, such as hematological cancers.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
Methods of inhibiting the growth or proliferation, or treating, myeloproliferative neoplasm using bi- specific molecules that bind to mutant calreticulin and CD3 are described.
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 35/02 - Antineoplastic agents specific for leukemia
74.
AI MODELS, SYSTEMS, AND METHODS FOR PREDICTING REMANUFACTURING FAILURES IN CAR T DRUG PRODUCTS
Systems and methods are disclosed for predicting remanufacturing failure in a production of a patient-specific CAR T drug product for a target patient. An example method includes: receiving quantitative data for a set of remanufacturing failure parameters; generating an input feature vector comprising the quantitative data for the set of remanufacturing failure parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting whether the production of the patient-specific CAR T drug product would result in the remanufacturing failure.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting patient-specific CAR T drug product dose and optimizing CAR T drug product manufacturing. An example method includes: receiving quantitative data for a set of CAR T drug product dose parameters; generating an input feature vector comprising the quantitative data for the set of CAR T drug product dose parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting a patient-specific CAR T drug product dose of a CAR T drug product for a target patient.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting patient-specific CAR T drug product viability and optimizing CAR T drug manufacturing. An example method includes: receiving quantitative data for a set of viability parameters; generating an input feature vector comprising the quantitative data for the set of CAR-T drug viability parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting a patient-specific CAR T drug product viability of a CAR T drug product for a target patient.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting a vector copy number (VCN) per transduced cell of a patient-specific CAR T drug product for a target patient. An example method includes: receiving quantitative data for a set of VCN parameters; generating an input feature vector comprising the quantitative data for the set of VCN parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting the VCN per transduced cell of the patient-specific CAR T drug product for the target patient.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting whether a patient-specific CAR T drug product for a target patient would be out of specification (OOS). An example method includes: receiving quantitative data for a set of OOS parameters; generating an input feature vector comprising the quantitative data for the set of OOS parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting whether the patient-specific CAR T drug product would be OOS.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting manufacturing failure in a production of a patient-specific CAR T drug product for a target patient. An example method includes: receiving quantitative data for a set of manufacturing failure parameters; generating an input feature vector comprising the quantitative data for the set of manufacturing failure parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting whether the production of the patient-specific CAR T drug product would result in the manufacturing failure.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting whether a patient-specific CAR T drug product for a target patient would undergo growth termination. An example method includes: receiving quantitative data for a set of growth termination parameters; generating an input feature vector comprising the quantitative data for the set of growth termination parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting whether the patient-specific CAR T drug product would undergo growth termination.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Embodiments herein relate to patient characteristics that are indicative of CAR-T cell manufacturing qualities. In certain aspects, parameters are collected and input through a trained algorithm to determine various attributes of the CAR T drug product. Such determinations may be used to optimize the manufacturing process for the CAR T drug product by adjusting various manufacturing parameters.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Systems and methods are disclosed for predicting a chimeric antigen receptor (CAR) in a patient-specific CAR T drug product for a target patient. An example method includes: receiving quantitative data for a set of CAR parameters; generating an input feature vector comprising the quantitative data for the set of CAR parameters; and applying, into a trained machine learning model, the input feature vector to generate an output feature vector predicting the CAR.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
C12N 5/0783 - T cellsNK cellsProgenitors of T or NK cells
Embodiments relate to methods of treating high-risk smoldering multiple myeloma in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a BCMAxCD3 bispecific antibody.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Embodiments of the present invention relate to methods of treating multiple myeloma in a subject in need thereof comprising administering to the subject a BCMAxCD3 bispecific antibody on a monthly dosing schedule.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 35/02 - Antineoplastic agents specific for leukemia
A61K 39/00 - Medicinal preparations containing antigens or antibodies
85.
COMBINATION REGIMENS FOR TREATING MULTIPLE MYELOMA
Embodiments of the present invention relate to methods of treating multiple myeloma in a subject in need thereof by administering therapeutically effective combination regimens comprising a GPRC5DxCD3 bispecific antibody and one or more of pomalidomide, daratumumab or lenalidomide.
A61K 31/454 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
86.
COMPOSITIONS COMPRISING ENHANCED MULTISPECIFIC BINDING AGENTS FOR AN IMMUNE RESPONSE
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
The application describes the first-in-human study on a PSMAxCD28 bispecific antibody, particularly on using a PSMAxCD28 bispecific antibody as a combination partner with a CD3 targeting molecule, in particular a KLK2xCD3 bi-specific antibody, to provide enhanced antitumor efficacy with a deeper and more durable clinical response, as well as an opportunity for enhanced tumor specificity by engaging two distinct tumor-associated antigens (TAAs).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
The present disclosure is directed to methods of treating multiple myeloma. The present disclosure is directed to methods of treating newly diagnosed multiple myeloma in a subject in need thereof, for example, by subcutaneously administering to the subject a pharmaceutical composition comprising an anti-CD38 antibody in combination with bortezomib, lenalidomide, and dexamethasone.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 31/454 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
The present application relates to improvements in lentiviral manufacturing for producing a CAR-T cell drug product, wherein the manufacturing method comprises changes to the time between host cell transfection and harvest, and new vector ratios for transfection. Presented herein are methods of preparing lentivirus with various vector ratios and times between host cell transfection and harvest, as well as transfection composition comprising the various vector ratios.
The present invention teaches compositions and methods for the generation of engineered and or engineerable cells, such as cells expressing a transmembrane polypeptide, for example a chimeric antigen receptor (CAR)-expressing cell, such as an immune cell, e.g., CD3+ immune cells, including gamma delta (γδ) T cells and the like.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
93.
METHODS AND MATERIALS FOR SCALABLE 3D CELLULAR REDIFFERENTIATION
Methods and materials for the cellular redifferentiation of induced pluripotent stem cell (iPSC)-derived hematopoietic stem cells (iHSCs) comprising a scalable, 3D method using a vertical-wheel bioreactor.
Provided herein are accessories for drug injection devices and methods of injecting a drug using the drug injection devices and the attached accessory. The accessory may comprise a first engagement surface that can engage the needle guard of the drug injection device and a second engagement surface that can engage a lower housing of the drug injection device. The needle guard of the drug injection device may be configured to transition between an extended position in which the needle guard shields a needle of the drug injection device and a retracted position in which the needle guard retracts relative to the lower housing to reveal the needle. When engaged with the corresponding portions of the drug injection device, the accessories described herein can prevent the needle guard of the drug injection device from transitioning from the retracted position to the extended position prior to completing the injection.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
95.
METHOD AND APPARATUS FOR FACILITATING ACCESS TO AN EYE
An ocular access instrument (20) includes an attachment assembly (32) configured to engage the sclera of an eye, and an actuator assembly (34) configured to bear against the sclera. When the attachment assembly engages the sclera, movement of the actuator assembly inward against the eye displaces the choroid from the sclera, thereby creating an enlarged suprachoroidal space. The ocular access instrument can further include a needle guide (40) that is configured to receive a needle and guide the needle into the enlarged suprachoroidal space.
A61F 9/00 - Methods or devices for treatment of the eyesDevices for putting in contact-lensesDevices to correct squintingApparatus to guide the blindProtective devices for the eyes, carried on the body or in the hand
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
The present disclosure provides methods for treating EGFR-positive non-small cell lung cancer (NSCLC) in a subject that had disease progression on or after treatment with at least one prior tyrosine kinase inhibitor (TKI).
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 31/5377 - 1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
Provided herein are, inter alia, materials and methods for bioengineered immunomodulatory fusion proteins and uses thereof for modulating immune responses, as well as improving a response of a subject in need therefore, such as to a vaccine, or treating a disease or disorder, such as cancer or a pathogen infection.
Provided herein are novel anti-CD20 x anti-CD28 antibodies and methods of using such antibodies for the treatment of B-cell malignancies. Subject anti-CD20 x anti-CD28 antibodies are capable of agonistically binding to CD28 costimulatory molecules on T cells and CD20 on tumor cells. Thus, such antibodies enhance anti-tumor activity at tumor sites. The subject antibodies provided herein are particularly useful in combination with other anti-cancer therapies (e.g., anti-CD3 x anti-CD20 x anti-CD79b antibodies) for the treatment of B-cell malignancies.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Provided herein are syringe accessories and methods of use thereof with syringes for injection. The syringe accessories described herein may include a single monolithic housing comprising a tubular portion configured to receive a barrel of a syringe, one or more flanges at a proximal end of the tubular portion, and a base portion at a distal end of the tubular portion. The base portion may extend outward in at least one direction from an outer surface of the tubular portion toward an end of the base portion that is configured to provide a stable contact surface on an injection site. The one or more flanges of the housing may be larger than that of the syringe inserted to the housing. The housing may be configured to limit protrusion of a needle when the syringe barrel is received in the tubular portion of the housing.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
patents
