Invivyd Inc, a pioneering biopharmaceutical company dedicated to safeguarding vulnerable populations from severe viral infectious diseases, unveiled promising preliminary findings today from the ongoing CANOPY Phase 3 pivotal clinical trial of their groundbreaking monoclonal antibody candidate, VYD222. This extended half-life, broadly neutralizing antibody is designed for the prevention of symptomatic COVID-19.
In response to this announcement, Invivyd’s stock witnessed a significant surge, experiencing a notable increase from its Friday closing value of $1.63. As trading commenced on Monday, the stock opened at $2.02 and is presently on an upward trajectory.
At the time of this publication, Invivyd Inc stock (IVVD) has witnessed a surge
Invivyd Inc
Current Price: $4.13
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The reported results underscore the favorable safety and tolerability profile of VYD222, with no serious adverse events related to the study drug reported to date. Adverse events attributed to VYD222 were predominantly Grade 1 or 2, indicating mild or moderate severity.
Additionally, the company revealed today that in vitro pseudovirus testing demonstrated VYD222’s potency against various SARS-CoV-2 variants currently in circulation, including HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3. Of particular significance, VYD222 exhibited neutralizing activity against variants carrying the F456L mutation, a mutation prevalent in the majority of U.S. variants.
Dave Hering, Chief Executive Officer of Invivyd, expressed satisfaction with the positive topline results from the CANOPY trial, stating, “We are pleased to share positive initial topline results from CANOPY, which bolster our belief that VYD222 holds the potential to provide vulnerable people, particularly the immunocompromised (IC), with meaningful protection from COVID-19.”
Hering further elaborated on the findings, highlighting that VYD222 demonstrated high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort. These levels mirrored those observed in the Phase 1 clinical trial of VYD222 conducted by Invivyd in healthy volunteers.
Encouraged by the potential early signal of robust clinical protection against symptomatic COVID-19 in the ongoing CANOPY trial, Hering emphasized, “We look forward to continued engagement with the FDA on these promising results, and we intend to submit a request for Emergency Use Authorization (EUA) as soon as practicable.”
As Invivyd progresses with its groundbreaking VYD222, the company remains at the forefront of the global effort to combat the ongoing COVID-19 pandemic, offering hope for vulnerable populations, particularly those at increased risk due to immunocompromised conditions. The positive outcomes from the CANOPY trial mark a significant milestone in advancing the development of a preventive solution against symptomatic COVID-19.