Avi Nova

Avi Novak, on behalf of Mike Ulz, asked for VIR's perspective on the competitive positioning of its PSMA-targeting T-cell engager, VIR-5500, following updated data from a competitor. He also questioned whether a median PFS of around 7.5 months is considered an achievable benchmark.

Answer

Marianne De Backer (Executive) expressed encouragement about the progress of masked T-cell engagers in general. She differentiated VIR's PRO-XTEN platform by highlighting its dual-mask technology, favorable safety profile with low CRS rates without prophylactic steroids, and a longer half-life enabling a more convenient Q3-week dosing schedule, which she noted is critical for tolerability and use in earlier lines of therapy.

Speaking for Mike Ulz, Avi Nova asked about the olezarsen launch in FCS, inquiring about the number of patients identified and Ionis's confidence in securing market share before a competitor enters. He also asked how quickly patients in early access programs could be transitioned to the commercial drug.

Answer

CEO Brett Monia stated that the sales and medical affairs teams are actively identifying patients and that the company's 9+ month head start is a key advantage for securing a bolus of patients at launch. He and Chief Global Product Strategy Officer Kyle Jenne added that a rapid transition from early access to commercial drug is planned post-approval via a dedicated patient support program, initially for U.S. patients.