Puma Biotechnology, Inc. | March 16, 2023
Puma Biotechnology, Inc., a biopharmaceutical company, recently announced the online publication of the Phase II TBCRC041 randomized clinical trial results in JAMA Oncology. The trial investigated the use of alisertib, an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A, alone or in combination with fulvestrant in postmenopausal women with endocrine-resistant, HER2-negative metastatic breast cancer who were previously treated with fulvestrant.
The Phase II randomized clinical trial was conducted via the Translational Breast Cancer Research Consortium and included patients previously treated with CDK 4/6 inhibitors and everolimus.
The trial enrolled 91 evaluable patients, with baseline characteristics balanced between the two arms of the trial. However, more patients in the alisertib plus fulvestrant arm had previously received chemotherapy for metastatic disease (47.8% in the alisertib alone arm vs. 68.9% in the alisertib plus fulvestrant arm). In each arm of the trial, all patients had earlier been treated with CDK 4/6 inhibitors. Everolimus was previously administered to 37% of patients in the alisertib alone arm and 57.8% in the alisertib plus fulvestrant arm.
The trial's efficacy results indicated that nine partial responses were observed in the 46 evaluable patients in the alisertib alone arm, leading to an overall response rate of 19.6%. The median duration of response was 15.1 months, with a clinical benefit rate of 41.3% at 24 weeks. The projected median progression-free survival (PFS) was 5.6 months. Nine of the 45 evaluable patients in the alisertib plus fulvestrant arm of the study responded, for an overall response rate of 20.0%. There was one patient who had a complete response and eight patients who showed partial responses. The median duration of response was 8.5 months, with a clinical benefit rate of 28.9% at 24 weeks. The median PFS was expected to be 5.4 months.
The most prevalent grade 3 or higher adverse events in the alisertib alone arm of the trial were neutropenia (43.4%), anemia (19.6%) and leukopenia (17.4%). The most prevalent grade 3 or higher adverse events in the alisertib plus fulvestrant arm of the study were neutropenia (42.2%), leukopenia (31.1%), lymphopenia (15.6%), fatigue (11.1%), and anemia (8.9%).
About Puma Biotechnology, Inc.
Puma Biotechnology, Inc. is a leading biopharmaceutical company specializing in the development and commercialization of innovative treatments for cancer. Its flagship product is Nerlynx (neratinib), an oral tyrosine kinase inhibitor approved by the USFDA for the extended adjuvant treatment of HER2-positive early-stage breast cancer. In addition to Nerlynx, it has a robust pipeline of product candidates in various stages of development. The company is firmly committed to research and development and collaborates with leading academic institutions and research organizations to advance the understanding of cancer and develop new therapies.
MEDTECH, INDUSTRIAL IMPACT
SOPHiA GENETICS and QIAGEN | March 06, 2023
SOPHiA GENETICS, a healthcare cloud-based software company, announced a new partnership with QIAGEN N.V. that will pair QIAseq reagent technology with the SOPHiA DDM™ platform to improve tumor analysis via next-generation sequencing (NGS).
Customers can utilize QIAseq panels with SOPHiA DDM™, a cloud-based data analysis platform to enable new research perspectives. The partnership will support the detection of somatic variants using QIAseq targeted DNA pro panels for homologous recombination repair. HRR is a biomarker test that helps identify tumors with specific mutations that may be sensitive to PARP inhibitors in oncology.
SOPHiA GENETICS's Set-Up Program, which aims to establish and demonstrate any test's analytical performance before it is carried out, will be integrated with QIAGEN's kits to support a range of applications. This partnership will allow customers to improve the design of new workflows using QIAseq technologies, while SOPHiA DDM™ will offer extensive applications for QIAGEN kits.
QIAGEN intends to expand its partnership with SOPHiA GENETICS to other analysis areas, such as utilizing custom solutions and QIAseq panels. This partnership is the first one in QIAGEN's QIAseq Platform Partnership.
Next-generation sequencing (NGS) can transform the detection and management of rare diseases and cancers. However, it also generates large, intricate, and messy datasets that are challenging to analyze. Identifying causal variants and getting valuable insights from NGS data requires specialized expertise, time, and numerous resources. The SOPHiA DDM™ Platform is a machine learning-based analytical tool that can efficiently call, annotate, and pre-classify variants from raw NGS data. In addition, it features user-friendly capabilities to facilitate prioritization, interpretation and reporting.
QIAGEN is a global provider of sample and assay technologies for academic and pharmaceutical research, molecular diagnostics, and applied tests. In addition, the firm offers a wide range of products and solutions for the isolation, purification, and analysis of DNA, RNA, and proteins, as well as automation and bioinformatics services. With over 35 countries and over 5,000 employees, QIAGEN serves customers in various fields such as human healthcare, animal health, and environmental testing. The company is headquartered in Venlo, Netherlands, and has offices and facilities across the globe.
MEDTECH, INDUSTRIAL IMPACT
Bio-Techne | February 15, 2023
On February 14, 2023, Bio-Techne Corporation and Cell Signaling Technology (CST) announced that CST antibodies now have Simple Western™ validation. This will make it easier for researchers from numerous disciplines to study essential molecular signaling pathways on a reliable and validated platform.
Accurate data must be obtained quickly and efficiently in order to advance drug discovery and development. This continued collaboration will provide a broader menu of Simple Western validated antibodies for a variety of targets across several disciplines.
Simple Western systems from ProteinSimple, a brand of Bio-Techne, are the only completely automated western blotting solutions for protein identification and characterization, with results available in as little as 3 hours. Cell Signaling Technology (CST) is a leading developer of antibodies and other related reagents for elucidating cell signaling pathways that govern cellular behavior and have an impact on human health.
CST has finished assay validation and optimization for a variety of its antibodies on the Simple Western platform, making it easier than ever to develop new reliable and robust immunoassays for the quantification and detection of phospho and total proteins. When using CST primary antibodies with Simple Western validation, researchers can simply dilute the antibody to the appropriate dilution range found on the data sheet and product page. In addition, CST antibodies are Simple Western protocol compliant, which allows users to include these thoroughly validated antibodies into their existing workflows seamlessly.
Founded in 1981, Bio-Techne Corporation is a pioneer in the development and manufacturing of high-quality purified proteins and reagent solutions, particularly antibodies, cytokines and growth factors, immunoassays, tissue culture reagents, biologically active small molecule compounds, and cell and gene therapy workflow solutions, including T-Cell activation technologies. It also develops and produces diagnostic products for OEM and clinical clients, such as FDA-regulated calibrators, controls, blood gas and clinical chemistry controls, and other reagents. The company’s products are essential components of scientific investigation into molecular diagnostics and biological processes, which disclose the diagnosis, nature, genesis, and course of certain diseases.