Novome announces positive results from GEMM cell therapy trial

Novome announces positive results from GEMM cell therapy trial

Novome Biotechnologies announced positive results of its phase 1 trial evaluating NOV-001, a once-daily Genetically Engineered Microbial Medicine for the treatment of enteric hyperoxaluria.“This study marks the first time that humans have been dosed with a therapeutically engineered microbe designed to engraft and grow in the human gastrointestinal tract,” Blake Wise, CEO of Novome, told…

FDA grants orphan drug designation to DF1001 for esophageal cancer

FDA grants orphan drug designation to DF1001 for esophageal cancer

The FDA granted orphan drug designation to DF1001 for treatment of esophageal cancer.DF1001 (Dragonfly Therapeutics) is a HER2-targeted natural killer cell engager therapy.The therapy — developed using Dragonfly’s TriNKET platform — is being evaluated for adults with advanced, HER2-positive solid tumors.A phase 1/phase 2 trial is underway to assess safety, tolerability, and preliminary biological and…