On 26 May 2025, Invivyd issued a press release with the first complete Phase 1/2 clinical data for VYD2311, the molecule designed to succeed Pemgarda:
• Delivery – Tested as a single intramuscular (IM) injection, as well as IV and sub-cutaneous.
• Safety – Only mild, transient injection-site reactions; no serious adverse events reported.
• Durability – Projected protective serum levels ≈ 76-day half-life; modelling suggests “months-to-quarters” of coverage.
• Potency – In lab assays, VYD2311 neutralized all currently circulating Omicron sub-lineages, including those with the troublesome F456L mutation that defeats older antibodies.
Important: These results are from an industry press release; the peer-reviewed article has not yet been published. We will share the full paper as soon as it appears.
Full press release here:
Why this matters for Canada
• Pemgarda already has proven Phase 3 efficacy, yet remains unavailable because Health Canada lacks an immune-bridging pathway.
• VYD2311 could be even better—one quick IM shot instead of two IV infusions—and may reach FDA review later this year.
• Without reform, Canada will once again stand on the sidelines while other countries move ahead with next-generation protection.
We will be sending a fresh letter to Health Canada highlighting the VYD2311 announcement and again requesting an immune-bridging pathway.
The science is moving quickly. Canada must move with it.
Thank you for refusing to let vulnerable people be left behind.
In solidarity,
Rowan
Petition link: https://www.change.org/MAbsForCanadaNOW
#MAbsForCanadaNOW #ProtectImmunocompromised #LongCOVIDTrialsNOW #COVID19IsNotOver