Invivyd (IVVD) Cantor Global Healthcare Conference 2025 summary

Portfolio and pipeline overview

• PEMGARDA is authorized for COVID-19 prevention in immunocompromised individuals under EUA, representing a significant technological achievement and a starting point for broader ambitions.

• VYD2311, a next-generation monoclonal antibody, is in pre-pivotal development, designed to be a low-dose, high-efficacy, and durable alternative to vaccines, aiming for broader population use.

• The company’s strategy focuses on minimally evolving antibodies to improve their properties against SARS-CoV-2, with the goal of offering a scalable, effective, and safer alternative to vaccination.

• Multiple studies confirm monoclonal antibodies can significantly reduce COVID-19 pathogenesis, supporting the pursuit of VYD2311 as a vaccine alternative for high-risk and pediatric populations.

• Constructive FDA dialogue has outlined a rapid path for advancing VYD2311, with ambitions to shift COVID-19 prevention from vaccine reliance to monoclonal antibody dominance in the coming year.

Regulatory and clinical development

• PEMGARDA’s regulatory journey was shaped by FDA and EMA decisions to limit its use to immunocompromised patients, resulting in a high-dose, high-cost, quarterly infusion model.

• VYD2311 is designed for intramuscular administration, aiming to overcome logistical and accessibility barriers faced by PEMGARDA and to align with mainstream prophylactic approaches.

• Recent regulatory updates suggest the FDA is open to a full BLA for VYD2311 for Americans 12 and up, based on existing CANOPY study data showing a 94% risk reduction at three months.

• The next steps involve designing and executing a confirmatory study in collaboration with the FDA to substantiate clinical benefit and safety for broader populations.

• The company is considering head-to-head or sub-studies versus vaccines, with the FDA requiring interim efficacy data by May 2026 and a longer-term readout thereafter.

Product profile and competitive positioning

• VYD2311 is expected to offer higher efficacy, safety, and durability compared to vaccines, with a user experience similar to vaccination but with fewer side effects.

• The antibody’s long half-life and IM administration are anticipated to provide a major advantage in protection and tolerability.

• The company aims to demonstrate clear medical value and drive practice-changing results, targeting millions of Americans who could benefit from robust protection.

• Success in clinical trials could make a head-to-head study with vaccines unnecessary if efficacy differences are clear.

• The company is leveraging its experience with similar antibodies to expedite development and regulatory approval.