Humanigen Inc (HGENQ)

[cowtown jay]

Good news for Invivyd (IVVD), and signals Regulatory stance on mAbs.

"March 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc...today announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19."

https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-interim-exploratory-data-vyd222-ongoing-canopy

Invivyd is defining 'pre-exposure' differently than I am accustomed to seeing. They are not saying their mAb is for covid-naive patients. They're saying just the opposite.

"Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection. By contrast, studies of prior authorized COVID-19 PrEP mAbs largely relied on participants required by protocol to be naïve to vaccination or prior infection." I guess the mass vaccination assault expanded the allowable definition of 'pre-exposure prophylaxis.'

In addition to the above Release Details, Invivyd also issued Release Details, which mentions the EUA.

https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-fda-authorization-emergency-use-pemgardatm

I'm actually encouraged by this.