NEW YORK – Agilent Technologies said this week the South Korea Ministry of Food and Drug Safety has approved the firm's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying individuals with non-small cell lung cancer who are eligible for first-line monotherapy with Merck's Keytruda (pembrolizumab) on the Dako Omnis platform, a fully automated system for staining tumor samples. Santa Clara, California-based Agilent noted it is the third approval of the test as a companion diagnostic to identify NSCLC patients who are suitable for treatment with Keytruda.
Mission Bio said that it has established a Center of Excellence (COE) at the Josep Carreras Leukaemia Research Institute in Barcelona, Spain. The company's first European COE will be led by Manel Esteller, the institute's director, and will inform academic and industrial best practices in hematological malignancy research as well as within a new breast cancer program using Mission's Tapestri single-cell DNA and multiomic sequencing platform. In March, Tapestri opened a COE in the US through a similar agreement with Jorge Reis-Filho's lab at Memorial Sloan Kettering Cancer Center.
EQRx said this week that the United Kingdom's Medicines and Healthcare Products Regulatory Agency accepted its marketing authorization application for aumolertinib for first-line treatment of patients with advanced or metastatic non-small cell lung cancer bearing EGFR mutations including EGFR T790M resistance mutations. The application is supported by data from the Phase III AENEAS trial, which showed improved progression-free survival in patients receiving aumolertinib compared to gefitinib.
The Center for Breakthrough Medicines (CBM) this week announced plans to build a cell and gene therapy manufacturing facility with the capacity to manufacture more than 10,000 cell therapies annually, including for cancer patients. The contract development and manufacturing organization said the facility will be the largest cell therapy manufacturing operation in the world and will cost hundreds of millions of dollars, though the exact price has not been determined. CBM says it will incorporate fully automated processes into its autologous cell therapy manufacturing capabilities before coming online. The CDMO will manufacture cell therapies for multiple academic institutions and companies, though it has not provided specific names.
The Breast Cancer Society of Canada this week announced a $250,000 grant to a project to identify unique markers linked to HER2-driven breast cancer recurrence at Dalhousie University. The three-year project is led by Paola Marignani, a professor of biochemistry and molecular biology at Dalhousie. The goal within the project will be to develop precision therapies that prevent breast cancer recurrence.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.