Gene-based Zika vaccine proves immunogenic in healthy adults

Investigator pipets
samples at the NIAID
Vaccine Research Center
Photo from NIAID
An experimental Zika vaccine is safe and induces an immune response in healthy adults, according to research published in The Lancet. Investigators tested 2 potential Zika vaccines, VRC5288 and VRC5283, in a pair of phase 1 trials. Both vaccines were considered well-tolerated, but one of them, VRC5283, induced a greater immune response than the other. Both vaccines were developed by investigators at the National Institute of Allergy and Infectious Diseases (NIAID). [Read Article]

Gene therapy seems safe, effective in hemophilia B

DNA helix
Image by Spencer Phillips
The gene therapy SPK-9001 has produced positive results in a phase 1/2 trial of adults with hemophilia B, according to researchers. SPK-9001 produced sustained factor IX (FIX) activity and allowed all 10 patients in this study to stop FIX prophylaxis. Eight patients had no further FIX treatment after SPK-9001, and 9 patients had 0 bleeds. There were no serious adverse events, and none of the patients had thrombotic events or developed FIX inhibitors. [Read Article]

FDA lifts partial hold on nivolumab trials

Nivolumab (Opdivo)
Photo from Business Wire
The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on 2 trials of the PD-1 immune checkpoint inhibitor nivolumab (Opdivo). In these trials, CheckMate-039 (CA209 -039) and CA204142, researchers are investigating nivolumab-based combinations in patients with relapsed or refractory multiple myeloma (MM). The partial clinical hold on these trials was a result of risks identified in studies involving another anti-PD-1 agent, pembrolizumab. [Read Article]