Arabella

Arabella, on behalf of Patrick Trucchio, asked if the inclusion of European sites in the Panorama GAD study could introduce variability in diagnostic practice, placebo behavior, or standard of care. She also inquired if positive results from both GAD studies would be sufficient for filing, or if additional long-term safety data would be required.

Answer

Dr. Daniel Karlin, Chief Medical Officer, acknowledged regional variations but assured that highly specified protocols, standardized diagnostic criteria, and central diagnostic/severity confirmation mitigate site variability. He added that enrollment is independent of local treatment patterns. Robert Barrow, CEO, stated that while premature for final filing strategy, positive dialogue with the FDA suggests Part A data (12-week durability) is what's needed for filing, and Definium is preparing for a rapid submission.

Arabella, on behalf of Patrick Trucchio from H.C. Wainwright, asked if the inclusion of European sites in the Panorama study could introduce variability due to differences in diagnostic practice, placebo behavior, or standard of care. She also inquired if positive results from both Voyage and Panorama GAD studies would be sufficient for filing an NDA, or if additional long-term safety data would be required.

Answer

Daniel Karlin, CMO, explained that while regional variations exist, Definium standardizes diagnostic criteria with central confirmation and uses monotherapy testing to mitigate variability. Robert Barrow, CEO, stated that while a final filing strategy is premature, positive FDA dialogue suggests Part A data demonstrating durability up to 12 weeks would be sufficient for filing, and Definium is preparing for a rapid submission.

Arabella from HC Wainwright asked about the current reach of Invivyd's commercial team and its strategy for expanding beyond infusion centers as the company transitions to intramuscular delivery for VYD2311. She also inquired about the differentiation strategy for Invivyd's early-stage RSV and measles discovery programs and their realistic timelines for development candidate nomination.

Answer

Tim Lee, Chief Commercial Officer, explained that the commercial team is building upon its foundation in infused specialty medication to target specialists caring for immunocompromised patients and future VYD2311 audiences. He mentioned plans for increased digital assets, community reach, and field presence over the next year. Marc Elia, Chairman, addressed the discovery programs, noting that measles antibodies offer easy differentiation due to lack of existing options, while RSV aims for differentiation through resistance profiles, potency, cost of goods, and delivery advantages against existing blockbuster antibodies. He anticipates an update on both programs before year-end, with rapid advancement into clinical space thereafter, though development paths for RSV and measles will likely diverge.

Arabella asked about the current reach of Invivyd's commercial team and its plans for expansion beyond infusion centers, particularly in anticipation of the transition to intramuscular delivery for VYD2311. She also inquired about Invivyd's strategy for differentiating its early-stage discovery programs in RSV and measles, and the realistic timeline for nominating development candidates.

Answer

Tim Lee, Chief Commercial Officer, explained that the company is building upon its existing foundation for infused specialty medication, expanding reach to specialists and the target audience for VYD2311. He highlighted plans for digital assets, community outreach, and increased field presence. Marc Elia, Chairman, detailed the differentiation strategy for measles (lack of existing antibodies, focus on potency, coverage) and RSV (differential resistance profile, biophysical properties). He stated that updates on both programs are expected before year-end, with rapid advancement into clinical development.