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Clinical Phase Articles & Analysis
60 articles found
This approach has gained rapid attention across academia, biotech, and big pharma. Clinical Progress Preceding Academic Validation Interestingly, clinical development in in vivo CAR-T advanced before large-scale academic confirmation was published. In June 2025, Capstan Therapeutics announced the initiation of a Phase I clinical ...
By focusing on streamlining the CAR-T development process, Alfa Cytology enables faster and more effective translation of laboratory research into viable clinical treatments. The preclinical phase is critical for identifying the potential efficacy and safety of CAR-T therapies before moving to human trials, and Alfa Cytology's approach is designed to optimize ...
Only 10% of drugs advanced to the clinical stage are successfully brought to market, with half of all failures attributed to lack of clinical efficacy. This means that approximately $60 billion dollars are spent annually on unsuccessful drugs.1,2 Contributing to these unchecked costs - and the complexity of drug discovery and development - is the fact that the ...
In vitro DMPK services, along with absorption, distribution, metabolism, excretion, and toxicity (ADMET) studies, play a vital role in predicting pharmacokinetic properties and potential adverse effects of drugs before they reach the clinical testing phase. In vitro DMPK services provide an array of tests that simulate the human body's response to a drug. ...
Therefore, there is a need to deepen our understanding of the physical, chemical, and biological properties of these adjuvants to provide a theoretical basis for determining the quality attributes of each adjuvant and selecting the appropriate type of adjuvant as early as possible in the clinical development phase. Type of Aluminum Adjuvants The two main types of ...
Candidate drugs like ARV110 and ARV-471 have entered Phase I/II clinical trials, indicating the potential of PROTACs in the treatment of cancer and other diseases. ...
In vitro DMPK services, along with absorption, distribution, metabolism, excretion, and toxicity (ADMET) studies, play a vital role in predicting pharmacokinetic properties and potential adverse effects of drugs before they reach the clinical testing phase. In vitro DMPK services provide an array of tests that simulate the human body's response to a drug. ...
With zapnometinib’s favorable outcome in a recent phase II clinical trial in hospitalized COVID-19 patients, the present results are even more promising for an upcoming phase II clinical trial in severe influenza virus infection. 1 Introduction As of today, virus infections, especially those with pandemic potential, ...
PMID: 31413909; PMCID: PMC6682371. [21] Buisseret L, Pommey S, Allard B, Garaud S, Bergeron M, Cousineau I, Ameye L, Bareche Y, Paesmans M, Crown JPA, Di Leo A, Loi S, Piccart-Gebhart M, Willard-Gallo K, Sotiriou C, Stagg J. Clinical significance of CD73 in triple-negative breast cancer: multiplex analysis of a phase III clinical trial. ...
It also has a strong competitor, Enhertu, in the approved breast cancer field. For example, in the ASCENT clinical trial, 9% of patients experienced rash and 5% of patients experienced eye toxicity. ...
Currently, the FDA has approved Krystal Biotech's new drug research application, allowing the company to initiate phase I clinical trials of KB407 in CF patients. Another promising gene therapy in development is 4D-710, an experimental aerosol gene therapy developed by 4D Molecular Therapeutics (4DMT). 4D-710 is designed to deliver an artificial version of the ...
These models can be used to study disease progression, test drug candidates, and gain insights into drug mechanisms of action. In the clinical development phase, single-cell RNA sequencing has the potential to inform decision-making in several ways. ...
Nearly 100 recombinant vaccine candidates are currently in Phase I clinical development, currently the largest number of all types. ...
Recently, in the renowned academic journal Nature Medicine, the Kimmel Cancer Center at Johns Hopkins University published Phase 2 clinical results regarding enoblituzumab, a monoclonal antibody targeting B7-H3, for the treatment of prostate cancer. ...
These models facilitate the study of disease progression, testing of drug candidates, and gaining insights into drug mechanisms of action. During the clinical development phase, scRNA-seq informs decision-making in several ways. ...
However, most ADCs targeting solid tumors have not progressed beyond phase 2 clinical trials. The limited penetration rate in solid tumors is one important reason, affected by the size of IgG. ...
Its approval was based on the EMILIA Phase III clinical study and the EMILIA Bridging Study in China, which showed that T-DM1 improved overall survival (OS) and progression-free survival (PFS), as well as better objective response rate (ORR) and median duration of response (DoR) compared to Lapatinib combined with capecitabine. ...
The Development Trend of PROTAC Verify the degradation of "non-druggable proteins" in clinical trials: At present, PROTAC molecules that have entered the clinical trial stage mainly target traditional AR, ER, BTK, etc. Kymera Therapeutics’ KT-333 targeting STAT3 and Astellas Pharma’s ASP3082 targeting KRAS G12D are in phase I ...
While killing HER2-positive cells, it is also killing tumor cells with low HER2 expression. The results of phase 3 clinical research on breast cancer with "low expression of HER2" show that the treatment effect of T-Dxd is significantly better than that of chemotherapy for breast cancer patients with low expression of HER2! ...
Most of these products are in early stage of development against SARS-CoV-2, but already have acquired clinical data (mostly phase 1 or 2) in other indications. One of the major challenges is the manufacturing of a new SARS-CoV-2 vaccine in large scale for global demand. ...
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