CIDRAP- NEWS BRIEF October 1, 2026

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Monoclonal antibody for COVID meets safety endpoints in phase 3 trial​

News brief

Today at 12:49 p.m.
Chris Dall, MA
Topics

COVID-19

US biopharmaceutical company Invivyd said this week that its investigational monoclonal antibody (mAB) for COVID-19 was found to be safe and tolerable in a phase 3 randomized clinical trial.

The LIBERTY trial enrolled 210 US healthy adults to assess the safety and tolerability of VYD2311, an mAB designed for the prevention and treatment of COVID-19. Participants were randomly assigned 1:1:1 to receive either VYD2311, the mRNA-based COVID-19 vaccine Comirnaty (Pfizer/BioNTech), or both.

The co-primary endpoints included the proportion of participants experiencing a treatment-emergent adverse event (TEAE), injection site reaction (ISR), hypersensitivity reaction, or systemic adverse event (AE) in the first six days following dosing.

The results showed 57% of participants who received VYD2311 experienced any TEAE, ISR, or hypersensitivity reaction, compared with 91% of those who received Comirnaty and 79% of participants who received both. Forty-four percent in the VYD2311 experienced a systemic AE, compared with 68% in the Comirnaty group and the 50% in the combined group.

Fewer patients in the VYD2311 groups experienced any TEAE, ISR, or hypersensitivity reaction over the long-term (56 days post-administration)—61%, compared with 91.4% in the Comirnaty group and 83% in the combined group.

Separate trial is evaluating efficacy​

Data from the trial also showed that combining VYD2311 with Comirnaty more than doubled recipients’ neutralizing titers.

“The LIBERTY data provide us with high confidence in the profile of VYD2311,” Invivyd Chief Medical Officer Michael Mina, MD, PhD, said in a company press release. He added that the finding on the combination of VYD2311 and Comirnaty “suggests potentially broader, as yet unexplored, complementarity between Invivyd monoclonal antibodies and vaccines against COVID-19 and perhaps other pathogens.”

VYD2311 is also being tested in the phase 3 DECLARATION trial, which is evaluating safety and efficacy in roughly 2,400 adults and adolescents with and without risk factors for severe COVID. Invivyd says it plans to pursue accelerated approval from the Food and Drug Administration based on data from the two trials.