The BioPharm Brief: Delivery, Priority, and Gene Therapy

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what we’re talking about today.

First, Biora Therapeutics is taking its BioJet oral delivery system into the clinic. The company is preparing to test its BioJet capsule in a first human trial, aiming to deliver adalimumab orally rather than by injection. The move follows preclinical results showing 51.3% bioavailability, offering a look at whether large biologic therapies can eventually be delivered through a more patient-friendly oral approach.

Next, Roche’s satralizumab has received FDA priority review for myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD. The designation could accelerate the review of satralizumab for this rare neurological disorder, where treatment options remain limited.

And Encoded Therapeutics has raised $275 million to advance its AAV gene therapy ETX101 for Dravet syndrome. The financing will support development of the therapy, which is designed to address the underlying genetic cause of the rare epilepsy disorder, as Encoded moves ETX101 forward in development.

That’s The BioPharm Brief for today. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

• Biora: BioJet enters first human testing for oral biologic delivery.
• Roche: Satralizumab gets FDA priority review for MOGAD.
• Encoded: $275 million raised to advance ETX101 for Dravet syndrome.