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.
MEDTECH, INDUSTRIAL IMPACT
Cybin | January 19, 2023
On January 18, 2023, Cybin Inc., a leading biopharmaceutical firm focused on advancing Psychedelics to Therapeutics®, announced the key findings from a feasibility study undertaken by its partner Kernel, which evaluated Kernel's Flow® wearable technology to assess ketamine's psychedelic effect on cerebral cortex hemodynamics. The findings of this Cybin-sponsored study are meant to guide the program's future direction.
The key highlights of the feasibility study are
It offered important proof-of-concept for Kernel Flow as a portable functional system that delivers real-time measurements of blood oxygenation changes in the brain linked with neural activity utilizing Time Domain Near Infrared Spectroscopy (TD-fNIRS).
Exhibited changes in functional brain biomarkers caused by ketamine that are related to potential therapeutic effects, including changes in cortical function associated with psychedelic experiences.
Compared to saline, ketamine reduces the global brain connectivity of the prefrontal region and decreases the brain-wide fractional amplitude of low-frequency fluctuations (fALFF). It has been proposed that fALFF is of particular functional significance within the default mode network, which has been demonstrated to be modulated by psychedelics and is associated with several neuropsychiatric conditions.
A model incorporating neurological and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, which has been shown to mediate reductions in depressive symptomatology in prior studies.
Displayed reliable pulse rate variability (PRV) and physiological measurements of pulse rate (PR) from TD-fNIRS recordings that correspond to those obtained from commercial external photoplethysmography sensors, thereby eliminating the need for external sensors to measure cardiac activity in future experiments.
Ketamine increased PR, decreased PRV, increased absolute oxy-hemoglobin concentrations and decreased deoxy-hemoglobin concentrations while increasing electrodermal activity (measured by an external sensor), providing additional physiological measures of the impact of the ketamine doses administered in the study.
The main goal of the feasibility study was to find out how people who had been given ketamine felt about wearing Kernel Flow while in an altered state of consciousness.
The feasibility study was granted FDA Investigational New Drug approval in October 2021 and US Institutional Review Board approval in January 2022.
Founded in 2019 and headquartered in Canada, Cybin is a biotechnology company that develops psychedelic pharmaceutical treatments for a variety of psychiatric and neurological disorders. It collaborates with a network of world-class partners and internationally recognized scientists to develop safe and effective treatments for patients dealing with a wide range of mental health conditions. The company is currently operating in the United States, Canada, the United Kingdom, Ireland, and the Netherlands.
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.