The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.

Gene therapy startup Latus Bio has raised another $42 million to start its first clinical trials, where it will try to sidestep issues that have set back a more advanced competitor. 

Latus is moving two treatments through clinical trials this year. The first is for a form of Batten disease called CLN2 disease, a fatal genetic condition that causes seizures, vision loss, and cognitive problems. The company anticipates having initial clinical data by the end of the year. 

Now, Latus — founded by Beverly Davidson, chief scientific strategy officer at the Children’s Hospital of Philadelphia — is turning its attention to a second drug candidate, a gene therapy for Huntington’s disease.

Continue to STAT+ to read the full story…

​Read More