(RTTNews) – Today’s Daily Dose brings you news about the first rolling review of a COVID-19 vaccine in the EU, reverse merger of privately held Chinook Therapeutics with Aduro, Enlivex Therapeutics’ positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition, FDA lifting the clinical hold on Solid Biosciences’ IGNITE DMD trial, and Vaccibody’s deal with Roche to develop neoantigen cancer vaccines.
1. EU begins First Rolling Review of COVID-19 vaccine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has started the ‘rolling review’ of AZD1222, the COVID-19 vaccine candidate, being developed by AstraZeneca plc (AZN) in collaboration with the University of Oxford.
This marks the first ‘rolling review’ of a COVID-19 vaccine, and the data being reviewed by the committee comes from laboratory studies (non-clinical data). The CHMP decided to start the rolling review of the AZD1222 vaccine based on preliminary results from non-clinical and early clinical studies which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defense) that target the virus.
AZD1222 advanced into phase III testing in the U.S. in late August. The vaccine candidate is being tested in phase II/III trials in the U.K. and Brazil and in phase I/II trial in South Africa.
Early this month, AstraZeneca paused all the AZD1222 vaccine trials following a single event of an unexplained illness, which is believed to be transverse myelitis that occurred in the UK phase III trial. While the trials of the vaccine candidate in the UK and other countries have resumed, the trial continues to remain on hold in the U.S. as regulators have asked the company to furnish further data over its safety.
Gilead Sciences’ antiviral Veklury (remdesivir), which secured