49 results about "Safety profile" patented technology

Belongs to the field of biological medicine, and relates to application of an anti-HER2 antibody drug conjugate to treatment of HER2 negative breast cancer. The invention also relates to application of the anti-HER2 antibody drug conjugate in preparation of a drug for treating HER2 negative breast cancer of a subject. The invention also relates to a method for treating HER2-negative breast cancer in a subject. The method comprises the step of administering the anti-HER2 antibody drug conjugate to the subject. The method is beneficial to HER2 negative breast cancer subjects, and has good safety.

A compound or a pharmaceutically acceptable salt thereof for use in a method of treatment of a disease or condition in which signalling through the PI3Kδ pathway is pathologically implicated in patients, for example cancer and inflammatory or autoimmune diseases. The compound is provided at a specified dose and has been found to have a favourable safety profile in humans, in particular with regard to hepatotoxicity, diarrhoea / colitis, respiratory infections, and hematologic toxicities.

This invention discloses the application and method of a STAT1-targeting inhibitor in the treatment of immune thrombocytopenic purpura (ITP). It employs ivermectin, a STAT1 nuclear translocation inhibitor, and fludarabine, a STAT1 activation inhibitor. By injecting either the activation inhibitor or the nuclear translocation inhibitor, the platelet count in a mouse model of ITP is increased. Fludarabine, a fluorinated nucleotide analog of vidarabine, is non-radioactive and a small-molecule phosphorylation inhibitor. Ivermectin is a small-molecule inhibitor of nuclear translocation mediated by α / β1 introgression protein. Both have high bioavailability and are widely used to treat various hematological diseases with good safety profiles. Their application in treating ITP is safe, effective, and shows high compliance.

The invention discloses a procyanidine trimer compound, which has a chemical structure as shown in the specification. The hypoglycemic potential of the compound is evaluated through an in-vitro enzyme inhibition experiment, and the result shows that the compound has a remarkable inhibition effect on alpha-amylase, has good water solubility, is derived from natural plant resources, is clear in structure and good in safety, and has a huge application prospect in development of novel natural-source hypoglycemic drugs.

The present disclosure is related to a device for gripping catheters that are used in interventional cardiac procedures without causing internal catheter damage. The present disclosure will allow the operator to maintain improved stability and maneuverability compared with current approaches, including, primarily, digital manipulation, which can lead to fatigue, instability and inappropriate catheter movement. Specifically in the pediatric population where small movements can lead to severe and permanent complications, the present disclosure has the potential to increase the safety profile of already high-risk interventional catheterization and electrophysiology procedures.

This invention discloses the application of American ginseng glycoprotein extract in the preparation of drugs for treating alcoholic liver disease, belonging to the field of biomedical technology. This invention verifies that TD can significantly reduce serum ALT, AST, and TG levels in ALD mice, effectively reducing liver damage and lipid accumulation; inhibit NLRP3 protein expression and its downstream targets, effectively alleviating liver inflammation and pyroptosis; and improve intestinal flora imbalance in ALD mice. American ginseng glycoprotein extract has multi-target protective effects against alcoholic liver disease, reducing alcohol-induced liver tissue inflammation and oxidative stress damage. It has a mild composition and high safety profile, and can synergistically exert effects in liver protection, anti-inflammation, and antioxidation, making it suitable for adjunctive intervention and long-term management of alcoholic liver disease, providing a natural, mild, and effective protective pathway for alcoholic liver damage.

The application provides novel N-heterocyclic compounds, such as quinoline or isoquinoline compounds, preferably quinazoline compounds, as calcineurin inhibitors (CNIs,) that provide improved safety profiles, and the pharmaceutical composition and formulation thereof, as well as a method of using the N-heterocyclic compounds for the treatment of, inter alia, an inflammatory-related disease or disorder.

In the field of gene therapy, a major hurdle is the design and identification of constructs and gene therapy vectors providing therapeutic effects while displaying satisfactory safety profiles. In the treatment of Diamond-Blackfan Anemia (DBA), therapies alleviating several crucial anemia symptoms, such as blood or bone marrow cellularity, hemoglobin levels, erythrocytes levels, or platelet levels, while showing satisfactory safety profiles remain a challenge. The present invention provides constructs encoding ribosomal protein genes involved in DBA, such as genes encoding RPS19, RPS17, RPS24, RPS10, RPL35a, RPL11, RPS26, and RPL5, vectors, methods, cells, and medical uses thereof, addressing these challenges and finding particular applications in the field of autologous cell therapy treatment of DBA. Further, the present invention provides a non-genotoxic conditioning protocol for preparing a subject prior to cell therapy treatment for DBA using construct of the present invention.

This disclosure pertains to the field of biomedicine and relates to the use of an anti-HER2 antibody-drug conjugate (ADC) for the treatment of breast cancer. It also relates to a method for treating a subject with breast cancer, the method comprising administering an anti-HER2 antibody-drug conjugate to the subject. Furthermore, it relates to the use of the anti-HER2 antibody-drug conjugate in the preparation of a medicament for neoadjuvant therapy of breast cancer. The method provides benefit to breast cancer subjects and has a good safety profile.

A novel treatment regimen is provided for the treatment of autoimmune disorders. Said novel treatment regimen provides for an efficacious treatment of autoimmune disorders with an advantageous safety profile and / or a high quality of life for the patient. Said novel treatment regimen provides for an advantageous benefit-risk ratio for patients endangered by the risk of infections.

A novel treatment regimen treats autoimmune disorders. Said novel treatment regimen efficaciously treats autoimmune disorders with an advantageous safety profile and / or a high quality of life for the patient. Said novel treatment regimen shows an advantageous benefit-risk ratio for patients endangered by the risk of infections.

The present invention is in the field of viral immunotherapy. The invention provides 1) an efficient recombinant poxvirus expressing a toxic conditional gene product that affects the viability of the recombinant poxvirus itself if left unregulated, or 2) a recombinant poxvirus expressing a conditional gene product with an improved safety profile, a method of producing them, a composition comprising them and therapeutic uses related thereto.

Provided are compositions and methods for treating cancers, in particular those characterized with PSMA expression such as prostate cancer. The compositions include a conditionally-activatable XTENylated Protease-Activated bispecific T Cell Engager targeting PSMA (PSMA-XPAT) that remain inactive until activated by proteases present in tumor microenvironment. The PSMA-XPAT exhibited exceptional safety profiles even at high doses and were efficacious in cancer patients resistant to even multiple lines of prior therapies.

Disclosed are improved Disabled Infectious Single Cycle (DISC) Herpes Simplex Virus (HSV) and their uses in the treatment of cancer or as a vaccine. Also disclosed are improved methods of making DISC HSV.

This invention belongs to the field of pharmaceutical technology, and relates to diphenylmethane derivatives, their preparation methods, and applications. The diphenylmethane derivative is a compound represented by Formula I, its optical isomer, or a pharmaceutically acceptable salt thereof: wherein X is CH2; Y is selected from: -NH-, -CO-, -NHCONH-. The diphenylmethane derivative of this invention is stable, easy to store, and readily prepared, exhibiting good feasibility. It demonstrates outstanding in vitro and in vivo efficacy and good safety profile when used to prepare anticardioprotective drugs (for heart failure and myocardial hypertrophy).

To provide antibodies that selectively and specifically bind to human monocarboxylate transporter 1 (MCT1), have desirable developability and patient-safety profiles, and can be used to treat MCT1 associated disorders, such as autoimmune diseases.SOLUTION: To provide antibodies having specific sequences and inhibiting MCT1 mediated responses (e.g., metabolic product transport, T-cell and B-cell proliferation) and / or driving regulatory T-cell differentiation, as well as compositions comprising such MCT1 antibodies, and methods of using such MCT1 antibodies and compositions.SELECTED DRAWING: None

The present disclosure provides a novel panel of fully humanized bispecific ADCs targeting CDH17 and another clinically validated target such as EGFR and HER2 for gastrointestinal cancers treatment. The bispecific ADCs offer improved target coverage, internalization rate and cytotoxicity over parental antibodies, as well as safety profile for a wider therapeutic window.

Compositions and methods are presented that, upon administration prior to trauma, are effective to prevent and / or reduce severity of sequelae of TBI upon trauma. Advantageously, the compositions presented herein can be orally administered, have an excellent safety profile, and will not require a prescription by physician or hospital admission. Further contemplated compositions and methods are presented to be effective to prevent and / or reduce severity of sequelae of glutamate excitotoxicity.

This invention relates to a macromolecular anticancer drug and a method for preparing it with controllable molecular weight. The macromolecular copper chelating agent of this invention possesses excellent copper ion binding capacity, significant copper-reducing effect, good safety profile, and good therapeutic and preventative effects against cancer. The method for preparing the controllable molecular weight of this invention is simple, has high yield, uses inexpensive and readily available raw materials, and operates under mild reaction conditions. It enables the large-scale, simple, and efficient preparation of the polymer of this invention, and allows for precise control of its molecular weight, thereby obtaining a macromolecular anticancer drug with a long metabolic time in vivo and good therapeutic effect on cancer metastasis.

The invention provides an antitumor drug with excellent antitumor efficacy and safety profile, exhibiting superior therapeutic effects. An anti-TROP2 antibody is provided, comprising: CDRH1 composed of an amino acid sequence of sequence identification number 23, CDRH2 composed of an amino acid sequence of sequence identification number 24, and CDRH3 composed of an amino acid sequence of sequence identification number 25 in the variable region of its heavy chain; and CDRL1 composed of an amino acid sequence of sequence identification number 26, CDRL2 composed of an amino acid sequence of sequence identification number 27, and CDRL3 composed of an amino acid sequence of sequence identification number 28 in the variable region of its light chain.

The present invention provides novel compositions, methods of treatment and methods of manufacture of large scale, commercially viable ibuprofen and acetaminophen tablets. The unique characteristics and synergistic effects resulting from the disclosed compositions, methods of treatment and methods of manufacture demonstrate a product with optimal analgesia, anti-pyresis, safety profiles and large-scale manufacturability. The inventions described herein surprisingly show the unique composition and method of manufacturing for a large-scale commercial batch of a novel ibuprofen and acetaminophen tablet.

The present specification describes CD24 binding antibodies and their fragments.The antibodies described herein have the useful property of not binding to either B cells or activated T cells.Such antibodies can have an enhanced safety profile with reduced immune side effects.In one aspect, the present specification describes an antibody or its antigen-binding fragment that binds to CD24, and the antibody does not bind to T lymphocytes.In certain embodiments, the antibody does not bind to activated T lymphocytes.

This invention relates to HeartTAC, an antibody protein that targets and degrades calprotectin, and its applications, belonging to the field of biomedical technology. This invention provides HeartTAC, an antibody protein that targets and degrades calprotectin, the amino acid sequence of which is shown in SEQ ID NO. 6 or SEQ ID NO. 4. This invention employs an extracellular targeted protein degradation scheme to construct HeartTAC, an antibody protein that targets and degrades calprotectin. This protein exhibits good targeting specificity to the heart, can degrade calprotectin in the heart, can significantly improve cardiac function, alleviate cardiac fibrosis, and has good safety profile. It opens up an important new direction for the prevention and control of cardiovascular diseases and has promising application prospects.

The present invention relates to an L-tryptophan-producing engineered strain of Clostridium butyricum and use thereof in the preparation of a drug for treating tumors, and pertains to the technical field of biomedical engineering. The tryptophan operon gene trpEDCBA is overexpressed in Clostridium butyricum by means of a thl promoter and a pMTL82151 shuttle vector to construct an engineered strain of Clostridium butyricum with a high L-tryptophan yield. The strain can specifically target and colonize tumors in mice without additional treatment. The strain secretes butanoic acid and tryptophan metabolites to inhibit IDO enzyme expression, regulate CD8+ T cell metabolism, and change the immune microenvironment of tumors, thereby achieving the purpose of inhibiting tumor growth. In addition, the strain will not affect the physiological structures of the major organs in the body, showing a favorable safety profile.

The present invention provides a compound for preventing or treating ocular diseases, a pharmaceutical composition, and an application thereof. The compound provided by the present invention is effective in controlling ametropia and axial length elongation, has a good safety profile, with no duration of use restrictions, and is capable of meeting the usage needs of adolescents with myopia.

The present disclosure relates to monoclonal antibodies that specifically bind to thymic stromal lymphopoietin (TSLP) and methods for treating atopic dermatitis. The antibodies block TSLP interaction with its receptor complex, preventing downstream inflammatory signaling. Administration involves weekly loading doses followed by biweekly maintenance doses, achieving superior clinical efficacy with >90% reduction in disease severity. The antibodies demonstrate favorable pharmacokinetics with a 25-day half-life, low immunogenicity, and a well-tolerated safety profile. This disclosure also covers methods for evaluating treatment efficacy and safety in moderate to severe atopic dermatitis patients.

This invention discloses a class of androgen receptor modulators, their preparation methods, and applications. The androgen receptor modulators are selected from compounds having the structural formula shown in Formula I. Experimental verification has shown that these compounds are all androgen receptor modulators, capable of significantly reducing the expression levels of androgen receptors in various cells and effectively inhibiting the proliferation of prostate cancer cells. They exhibit good safety profiles and have potential for further development.

The application provides novel N-heterocyclic compounds, such as quinoline or isoquinoline compounds, preferably quinazoline compounds, as calcineurin inhibitors (CNIs,) that provide improved safety profiles, and the pharmaceutical composition and formulation thereof, as well as a method of using the N-heterocyclic compounds for the treatment of, inter alia, an inflammatory-related disease or disorder.

Disclosed are a chloroquine structure-containing compound, a composition containing same, and an application thereof. The present invention provides a compound as represented by formula (I) or a pharmaceutically acceptable salt thereof. The chloroquine structure-containing compound provided by the invention is a nano material obtained from the synthesis of chloroquine, a derivative thereof, and a lipid tail. The nano material can be applied to gene therapy, drug delivery, and the like. A lipid nanoparticle (LNP) formed from the nano material and mRNA has a novel nanoscale spatial structure different from that of a traditional LNP, and compared to a traditional LNP, the nano material has better pharmaceutical properties. The LNP exhibits an immunosuppressive function, avoids triggering an excessive inflammatory response, and has a higher safety profile.

This invention discloses a ternary nanoparticle, its preparation method, and its applications, relating to the field of biomedical technology. The invention constructs a carrier-free, fully active ternary nanoparticle (diPCL NPs). This nanoplatform connects PTX dimer (diPTX), celecoxib (CXB) dimer (diCXB), and lonidamine (LND) dimer (diLND) via disulfide bonds for chemoimmunotherapy of drug-resistant tumors. diPCL NPs accumulate at tumor sites through enhanced permeability and retention (EPR) effects and circulate continuously in the bloodstream. In the high GSH tumor microenvironment, disulfide bond cleavage releases the active drug, exerting chemotherapeutic, immune-activating, sensitizing, and metabolic-regulating effects. diPCL NPs exhibit high antitumor efficacy and good safety profile within the therapeutic window in both breast cancer and paclitaxel-resistant models.