Invivyd, Inc.(formerly Adagio Therapeutics, Inc.) engages in the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The firm develops antibodies that can neutralize SARS-CoV-2, SARS-CoV-1, and additional emergent coronaviruses. It offers, ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses. The company was founded by Tillman U. Gerngross, Ren Russo and Laura Walker on June 3, 2020 and is headquartered in Waltham, MA.
相关临床试验
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3 进行中
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进行中（未招募）
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33.3%
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22.2%
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- Invivyd's post-hoc analysis of adintrevimab data from the EVADE trial revealed only 2% of patients experienced Grade 2/3 systemic adverse events within seven days, compared to 91.6% for mRNA vaccines and 83.6% for protein vaccines. - The monoclonal antibody approach demonstrated minimal symptomatic burden with virtually no difference from placebo, while vaccines caused 3.1-3.5 days of symptoms on average. - The company plans to initiate the LIBERTY Phase 3 trial to directly compare VYD2311 monoclonal antibody candidate with mRNA vaccination in a head-to-head controlled study. - These findings highlight the potential for monoclonal antibodies to provide COVID-19 protection without the significant tolerability burden associated with current vaccination approaches.
- Invivyd published peer-reviewed research demonstrating that serum monoclonal antibody levels can predict clinical protection from COVID-19 across multiple Omicron variants, regardless of viral mutations outside the drug target. - The analysis used data from the CANOPY Phase 3 trial of pemivibart to establish a correlate of protection model that shows meaningful protection even at low antibody concentrations. - The findings support the predictability of clinical efficacy when targeting stable viral epitopes and could potentially accelerate regulatory pathways for future monoclonal antibody development. - External experts suggest this approach could expand COVID-19 protection strategies beyond current vaccine-dependent approaches, offering durable variant-agnostic protection.
- Adimab announced 11 new partner programs entered clinical trials in 2025, bringing the total number of clinical programs to 89 since 2009. - Six therapeutic products containing Adimab-discovered or optimized molecules have received commercial approval, including GSK's Exdensur for severe asthma. - The company's antibody discovery platform has generated over 650 therapeutic programs across partnerships with more than 140 pharmaceutical and biotechnology companies. - Adimab Royalty Company structure, established in 2024, is now generating revenue from the first wave of approved products containing the company's molecules.
- Invivyd has identified VBY329, a monoclonal antibody candidate that demonstrates 1.5-fold greater antiviral potency than nirsevimab and up to 500-fold enhanced neutralization against nirsevimab-resistant RSV variants. - The company plans to advance VBY329 toward IND readiness in the second half of 2026 for pediatric RSV prophylaxis in a market expected to reach $3-4 billion annually by 2030. - VBY329 was developed using Invivyd's proprietary antibody discovery platform and targets RSV prevention in newborns, infants, and children under 24 months. - The candidate's half-life extension technology and biophysical properties are expected to provide equivalent or greater in vivo half-life compared to current standard of care treatments.
- Invivyd completed a $57.5 million public offering in August 2025 to accelerate development of monoclonal antibody candidates for respiratory syncytial virus, measles, and Long COVID treatments. - The company aims to identify a best-in-class RSV monoclonal antibody candidate by Q3 2025, targeting a $3 billion global market opportunity by 2027. - Invivyd's SPEAR Study Group launched in July 2025 represents entry into the $10 billion+ Long COVID treatment market through collaboration with leading researchers. - The capital raise is paired with a $30 million non-dilutive term loan from Silicon Valley Bank, providing financial flexibility while minimizing equity dilution.
- Invivyd announced that PEMGARDA (pemivibart) demonstrates continued neutralizing activity against the currently dominant XFG SARS-CoV-2 variant, maintaining efficacy as COVID-19 infections rise across 34 U.S. states. - The company's next-generation monoclonal antibody candidate VYD2311 showed similarly consistent and highly potent neutralization results against XFG and other circulating variants. - Both antibodies target structurally stable epitopes on the SARS-CoV-2 spike protein, with Invivyd estimating that every clinical variant since Omicron BA.2 has remained susceptible to pemivibart. - The neutralization data will be provided to the FDA imminently for potential inclusion in PEMGARDA's healthcare provider fact sheet, supporting continued use in immunocompromised patients.
- Three prominent clinical trials testing Paxlovid and monoclonal antibodies for Long COVID failed to show significant health improvements compared to placebo groups. - The trials were designed as "proof of concept" studies to test viral persistence theory, with researchers acknowledging they expected challenging results but hoped for better outcomes. - Future trials are being designed with longer treatment durations, larger patient populations, and more specific biomarkers to better target viral persistence in Long COVID patients. - New monoclonal antibody trials are underway, including sipavibart at Nova Southeastern University and planned studies with Pemgarda, which may offer longer-lasting effects than short-course antivirals.
- Invivyd has established the SPEAR Study Group with leading researchers to investigate monoclonal antibody therapy for Long COVID and Post-Vaccination Syndrome, following anecdotal reports of symptom relief with PEMGARDA. - The study group will conduct rigorous clinical trials to evaluate the safety and efficacy of anti-SARS-CoV-2 spike protein monoclonal antibodies in patients with persistent viral reservoirs or circulating spike protein. - Long COVID affects approximately 5% or more of Americans with no approved treatments currently available, representing a significant unmet medical need. - The initiative aims to generate data for potential registrational studies and regulatory pathways, with Invivyd planning FDA discussions on rapid approval pathways for COVID-19 monoclonal antibodies.
- Invivyd's CANOPY Phase 3 trial demonstrated that PEMGARDA (pemivibart) achieved an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months (nominal p <0.0001). - The study represents the first placebo-controlled trial of an authorized COVID-19 monoclonal antibody conducted in a contemporary U.S. population already seropositive from prior infection or vaccination. - PEMGARDA was generally well-tolerated with infusion-related reactions occurring in 3.6% of immunocompromised patients and 2.2% of immunocompetent participants. - The trial results support the FDA's emergency use authorization of PEMGARDA for pre-exposure prophylaxis in moderate-to-severe immunocompromised patients.
- Upstream Bio has appointed Stacy Price as Chief Technology Officer, bringing over 25 years of biotechnology experience to oversee technical operations and product development for verekitug. - Price will focus on chemistry, manufacturing, and controls (CMC) processes and drug delivery as Upstream Bio prepares to initiate a third clinical program for verekitug, their monoclonal antibody targeting inflammatory respiratory diseases. - The appointment comes at a pivotal time for Upstream Bio as they advance verekitug in Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with plans to expand into chronic obstructive pulmonary disease.
