News briefing: FDA lifts a hold on Poseida study; Decibel adopts 2-AAV approach to hearing loss; AstraZeneca partners on combos, again
A little more than 2 months ago, shares of newly public Poseida Therapeutics $PSTX cratered after the biotech reported that a patient death had spurred the FDA to drop a full hold on its lead cancer drug. This morning we learned that regulators lifted the hold, but details are sparse.
In a statement out early Monday, Poseida said that regulators had lifted the hold on their Phase I study for their CAR-T P-PSMA-101 in prostate cancer. Here’s why:
The Company has agreed to implement protocol amendments intended to increase patient compliance and safety that include modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
So there’s no explanation of what had caused the death or exactly what was being done to correct the trial design.
Decibel snags IP for a 2-AAV approach to fixing congenital hearing loss
Decibel Therapeutics thinks it has found a strategy to tackle a gene therapy for congenital hearing loss.
Confronted by the challenge of delivering the large otoferlin gene to fix the profound hearing loss triggered by mutations of the gene, researchers at the University of Florida and UC San Francisco have come up with a 2 AAV approach to the problem. They are using 2 vectors to deliver the full gene.
And Decibel is in-licensing the tech from William Hauswirth and Omar Akil to try it in humans.
We were able to cure deafness in a mouse model and look forward to the potential of this technology in the development of a gene therapy to restore hearing in human patients.
Fusion partners up with AstraZeneca on a new combination strategy for cancer
A few days after AstraZeneca $AZN tied up with Arcus $RCUS to test a combination of their PD-L1 checkpoint Imfinzi with the biotech’s anti-TIGIT therapy, the pharma giant is back with another alliance aimed at radiopharmaceuticals.
Fusion Pharmaceuticals is partnering their lead drug off the Targeted Alpha Therapies platform with drugs out of AstraZeneca. Their teams will develop novel TATs as well as antibodies from the global company. And like the Arcus deal, both companies will retain full ownership of their products.
Fusion CEO John Valliant noted: We believe (this deal) is evidence of the growing interest in the use of molecularly-targeted radiation as a next-generation cancer therapy.”