- |||||||||| Review, Journal, Gene therapy: Current State of Human Gene Therapy: Approved Products and Vectors. (Pubmed Central) - Oct 28, 2023
In this comprehensive exploration, we delve into a rich assortment of 16 drugs, from siRNA, miRNA, and CRISPR/Cas9 to DNA aptamers and TRAIL/APO2L, as well as 46 carriers, from AAV, AdV, LNPs, and exosomes to naked mRNA, sonoporation, and magnetofection. The article also discusses the advantages and disadvantages of each product and vector type, as well as the current challenges faced in the practical use of gene therapy and its future potential.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: The RANK-RANKL-OPG System: A Multifaceted Regulator of Homeostasis, Immunity, and Cancer. (Pubmed Central) - Oct 28, 2023 RANKL-neutralizing antibodies, such as denosumab, have been shown to be effective in the treatment of skeletal-related events, including osteoporosis or bone metastases, and cancer. This review will provide a comprehensive overview of the functions of the RANK-RANKL-OPG system in bone metabolism, mammary epithelial cells, immune function, and cancer, together with the potential therapeutic implications of the RANK-RANKL pathway for cancer management.
- |||||||||| Ibrance (palbociclib) / Pfizer
Preclinical, Journal: In Vitro microRNA Expression Profile Alterations under CDK4/6 Therapy in Breast Cancer. (Pubmed Central) - Oct 28, 2023 Because they are secreted and significantly upregulated in the microenvironment of tumor cells, miRs-100, -10b and -182 are promising circulating biomarkers that can be used to predict or detect therapy responses under CDK inhibition. MiR-10a, miR-15b, miR-21, miR-23a and miR-23c are potential tissue-based biomarkers.
- |||||||||| Journal, Tumor mutational burden, IO biomarker: A novel prognostic N-methylguanosine-related long non-coding RNA signature in clear cell renal cell carcinoma. (Pubmed Central) - Oct 28, 2023
Quantitative real-time polymerase chain reaction (qRT-PCR) exhibited that the expression levels of LINC01507, AC093278.2 were very high in all five ccRCC cell lines, AC084876.1 was upregulated in all ccRCC cell lines except 786-O, and the levels of AL118508.1 and DUXAP8 were upregulated in the Caki-1 cell line. This risk model may be promising for the clinical prediction of prognosis and immunotherapeutic responses in patients with ccRCC.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
Enrollment change, Trial termination: Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout (clinicaltrials.gov) - Oct 27, 2023 P4, N=5, Terminated, Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 N=40 --> 5 | Suspended --> Terminated; The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug
- |||||||||| Campath (alemtuzumab) / Sanofi, Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment closed, Enrollment change, Trial primary completion date: Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease (clinicaltrials.gov) - Oct 27, 2023 P1/2, N=55, Active, not recruiting, N=40 --> 5 | Suspended --> Terminated; The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug Recruiting --> Active, not recruiting | N=98 --> 55 | Trial primary completion date: Sep 2025 --> Jul 2023
- |||||||||| Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Pfizer
Trial completion, Trial completion date, Combination therapy, Metastases: Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer (clinicaltrials.gov) - Oct 27, 2023 P1/2, N=42, Completed, Recruiting --> Active, not recruiting | N=98 --> 55 | Trial primary completion date: Sep 2025 --> Jul 2023 Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Feb 2023
- |||||||||| Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
Journal: Discovery of Hit Compounds Targeting the P4 Allosteric Site of K-RAS, Identified through Ensemble-Based Virtual Screening. (Pubmed Central) - Oct 27, 2023 The present study also describes the results of a virtual screening study focused on the discovery of hit compounds, binders of the P4 site that can be considered as peptidomimetics of a fragment of the SOS ?I helix, a guanine exchange factor of Ras. After a detailed description of the computational procedure followed, we disclose five hit compounds, prospective binders of the P4 allosteric site that exhibit an inhibitory capability higher than 30% in a cell proliferation assay at 50 ?M.
- |||||||||| Repatha (evolocumab) / Amgen, Astellas
Trial completion date, Trial primary completion date: EVACS: Evolocumab in Acute Coronary Syndrome (clinicaltrials.gov) - Oct 26, 2023 P2, N=60, Active, not recruiting, Not yet recruiting --> Recruiting Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Adverse events: Use and risk of side effects of antiresorptive medication in people with intellectual disabilities. (Pubmed Central) - Oct 26, 2023 Increased awareness of osteoporotic fracture risk in ID may lead to wider use of antiresorptive drugs (bisphosphonates and denosumab) in this population...However, the potential for side effects of antiresorptives will inherently increase with wider use of these drugs. Given the higher incidence of oral pathology in people with ID, which could put them at higher risk of ONJ, precautions should be taken to prevent this complication by attention to oral health.
- |||||||||| Repatha (evolocumab) / Amgen, Astellas
Trial completion: CHORD: CHOlesterol Lowering and Residual Risk in Type 2 Diabetes (clinicaltrials.gov) - Oct 26, 2023 P4, N=151, Completed, Physicians may take subsequent cardiovascular risks into account when choosing an adequate antiosteoporosis medication for patients with osteoporosis. Recruiting --> Completed
- |||||||||| Lumakras (sotorasib) / Amgen
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (clinicaltrials.gov) - Oct 25, 2023 P1/2, N=713, Active, not recruiting, Trial completion date: Sep 2023 --> Sep 2024 Trial completion date: May 2027 --> Nov 2027 | Trial primary completion date: May 2027 --> Nov 2027
- |||||||||| Lumakras (sotorasib) / Amgen
Journal, Combination therapy: Engineered a dual-targeting HA-TPP/A nanoparticle for combination therapy against KRAS-TP53 co-mutation in gastrointestinal cancers. (Pubmed Central) - Oct 25, 2023 The co-loaded HA-TPP/A nanoparticles demonstrated remarkable therapeutic efficacy in a tumor-bearing mouse model, particularly in KRAS-TP53 double mutant expressing cancer cells, compared with single drug and combined free drug groups. Notably, HA-TPP/A is the first reported nanoparticle with an ability to co-target KRAS-TP53, providing a promising approach for therapy in highly malignant gastrointestinal tumors and potentially expanding clinical indications for AMG510 targeted therapies in gastrointestinal tumors.
- |||||||||| Campath (alemtuzumab) / Sanofi, Neupogen (filgrastim) / Kyowa Kirin, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Improvement in Clinical and Patient-Reported Outcomes for Refractory Juvenile-Onset Systemic Sclerosis (jSSc) 6 Months to 2 Years After Autologous Stem Cell Transplantation (ASCT) (Poster Hall; In Person) - Oct 24, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4572; P2 Among our cohort of refractory jSSc patients with moderate-severe disease, ASCT was a safe and effective intervention that provided sustained global disease modifying improvement throughout 2 years after transplant. Most notable improvements were in skin, gastrointestinal, pulmonary, and patient-reported functional domains.
- |||||||||| Krystexxa (pegloticase) / Amgen, Kineret (anakinra) / SOBI, Ilaris (canakinumab) / Novartis
Journal: Comparison table: Some drugs for gout. (Pubmed Central) - Oct 24, 2023 Together, we unveil CDK6 as a druggable target in lenvatinib-resistant HCC and highlight the use of a chemical biology approach to understand nongenetic resistance mechanisms in cancer. No abstract available
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Preclinical, Journal, IO biomarker: A CD3 humanized mouse model unmasked unique features of T-cell responses to bispecific antibody treatment. (Pubmed Central) - Oct 24, 2023 T-cell bispecific antibodies (T-BsAbs) such as blinatumomab hold great promise for cancer immunotherapy...Humanizing the target antigen in the recipient mice is crucial to facilitate tolerance induction and successful establishment of high tumor burden. Our findings underscore the importance of meticulously optimized syngeneic murine models for investigating T-BsAb-induced immune responses and for translational research aimed at improving efficacy and safety.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen
Review, Journal, Checkpoint inhibition: Isolated Neutropenia Due to Immune Checkpoint Inhibitors. (Pubmed Central) - Oct 24, 2023 Our findings underscore the importance of meticulously optimized syngeneic murine models for investigating T-BsAb-induced immune responses and for translational research aimed at improving efficacy and safety. This review discusses different therapeutic interventions, ranging from the administration of corticosteroids and intravenous immunoglobulin (IVIG) to the use of granulocyte colony-stimulating factor (filgrastim) and, in very severe cases, a stem cell transplant...Achieving this equilibrium is very important in optimizing patient care during immunotherapy, as these irAE management options can both
- |||||||||| Review, Journal: Efficacy and Safety of Anti-calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies in Preventing Migraines: A Systematic Review. (Pubmed Central) - Oct 24, 2023
This included the four Food and Drug Administration (FDA)-approved medications erenumab, galcanezumab, fremanezumab, and eptinezumab...The results further imply that combination treatment with CGRP antibodies and onabotulinumtoxinA may enhance the prevention of migraine in adults...Additionally, the study discovered considerable variances in effectiveness amongst various groups. However, further investigation is required to establish the best time and dosage and the effect of patient characteristics on the effectiveness and safety of these medications.
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