Invivyd forms the SPEAR Study Group to evaluate pemivibart for Long COVID and post-vaccine syndrome, exploring monoclonal antibody treatment of spike protein.
Invivyd, Inc announced the formation of the SPEAR (Spike Protein Elimination and Recovery) Study Group, a collaborative clinical and translational research initiative to evaluate monoclonal antibody therapies, including pemivibart (Pemgarda), for potential treatment of Long COVID and COVID-19 Post-Vaccination Syndrome (PVS). The initiative responds to growing anecdotal reports of clinical improvement in patients with persistent SARS-CoV-2 spike protein exposure following pemivibart therapy, although the product is currently authorized only for COVID-19 pre-exposure prophylaxis in certain immunocompromised populations.1
Upcoming trials will assess monoclonal antibody safety, biological mechanisms, and exploratory efficacy in patients with persistent viral reservoirs or circulating spike protein.1 The SPEAR Study Group includes leading researchers in Long COVID biology and rehabilitation:
Though originally developed for pre-exposure prophylaxis, pemivibart’s efficacy and durability in the CANOPY trial demonstrates its potential in addressing longer-term, spike protein–driven disease. Invivyd’s phase 3 CANOPY trial, recently published in Clinical Infectious Diseases, showed an 84% relative risk reduction in symptomatic COVID-19 with pemivibart during a 6-month on-drug period, and 74% in the 6 months after. The trial included immunocompromised individuals, a group with limited vaccine protection.2
The SPEAR Study Group will assess the safety, mechanisms, and potential efficacy of pemivibart in treating Long COVID and PVS.
Pemivibart demonstrated 84% relative risk reduction in symptomatic COVID-19 in the CANOPY trial, supporting expanded clinical use beyond pre-exposure prophylaxis.
Ongoing in vitro data show pemivibart retains neutralizing activity against emerging variants, reinforcing its potential for treating spike protein–driven conditions.
“This is the only monoclonal antibody currently available that has retained efficacy even after the emergence of Omicron,” said Mark Wingertzahn, PhD, senior vice president of clinical development and medical affairs at Invivyd in a recent Q&A with Contagion. These data reinforce the therapeutic potential of pemivibart in high-risk populations, laying groundwork for further clinical applications beyond prophylaxis.2
Additionally, recent data further supports the scientific foundation for evaluating pemivibart in Long COVID and PVS. The company reported that pemivibart continues to demonstrate strong in vitro neutralizing activity against the dominant SARS-CoV-2 variant LP81, as well as previously circulating variants JN1, KP311, and XEC. The neutralization activity of both pemivibart and Invivyd’s next-generation monoclonal antibody candidate, VYD2311, remained unaffected due to the preservation of the targeted spike protein epitope. This finding supports the rationale behind using broadly neutralizing monoclonal antibodies for conditions potentially driven by persistent viral reservoirs or circulating spike protein.3
“Pemivibart neutralization activity has been remarkably stable in the face of constant SARS-CoV-2 evolution,” said Robert Allen, PhD, chief scientific officer at Invivyd. “Scientifically, the ongoing in vitro neutralization activity as reported for pemivibart is a demonstration of our foundational hypothesis: that virus variants with the structural properties required for fitness and broad infectivity among humans will also likely be susceptible to pemivibart.” 3
The company has shared updated data with the FDA and expects changes to the pemivibart provider fact sheet. This ongoing tracking of variants and the drug’s stability over time further support Invivyd’s decision to begin studying pemivibart as a possible treatment for conditions linked to lingering spike protein.
“It is now clear from a growing body of high-quality, peer-reviewed research that persistent spike protein or viral reservoirs can be identified in a meaningful portion of people with Long COVID,” said Peluso in the press release. “This research marks an essential step toward understanding what may cause debilitating COVID-driven chronic disease.”1
Invivyd plans to meet with the FDA in Q3 2025 to discuss expedited regulatory pathways for monoclonal antibody therapies and will continue advancing next-generation candidates such as VYD2311. According to Invivyd Board Chairman Marc Elia, the SPEAR Study Group represents “a critical step toward potentially unlocking a Long COVID treatment opportunity for patients in need by generating data needed to inform future studies and potential regulatory pathways.”1
