NorthWest Biotherapeutics Inc (NWBO)

[LearningEveryTrade]

IBTA Newsletter August 2022
https://mailchi.mp/theibta/rculorsyeg-2299398
Company news
Northwest Biotherapeutics’ Paediatric Investigation Plan is approved by UK Medicines and Healthcare products Regulatory Agency, laying the groundwork for approval of DCVax®-L in adult patients
Northwest Biotherapeutics has announced that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the company’s Paediatric Investigation Plan (PIP). The development, regulatory review and regulatory approval of a PIP is a prerequisite for application for approval of a new medicine for adult patients, such as DCVax®-L. The approved PIP includes two clinical trials: one for newly diagnosed paediatric high-grade glioma (HGG), and one for recurrent paediatric HGG. In each of the two paediatric trials, 24 patients will be treated with DCVax®-L on the same treatment schedule as in the company’s Phase III trial in adult glioblastoma patients. DCVax®-L uses activated dendritic cells (the master cells of the immune system), and is designed to reinvigorate and educate the immune system to attack cancers. Read more (company press release).