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Invivyd

Invivyd logo
🇺🇸United States
Ownership
Public
Employees
95
Market Cap
$109.8M
Website
http://invivyd.com
Introduction

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.

Clinical Trials

7

Active:2
Completed:2

Trial Phases

3 Phases

Phase 1:3
Phase 2:2
Phase 3:1

Drug Approvals

1

FDA:1

Drug Approvals

pemgarda

Approval Date
Mar 22, 2024
FDA

Clinical Trials

Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (50.0%)
Phase 2
2 (33.3%)
Phase 3
1 (16.7%)

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants

Phase 1
Active, not recruiting
Conditions
COVID-19
Interventions
Other: Placebo
First Posted Date
2024-07-26
Last Posted Date
2024-11-19
Lead Sponsor
Invivyd, Inc.
Target Recruit Count
40
Registration Number
NCT06523153
Locations
🇦🇺

Invivyd Investigative Site, Joondalup, Western Australia, Australia

A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2

Phase 3
Completed
Conditions
COVID-19
SARS-CoV-2
Interventions
Drug: VYD222 (pemivibart)
Drug: Normal saline
First Posted Date
2023-09-15
Last Posted Date
2024-12-09
Lead Sponsor
Invivyd, Inc.
Target Recruit Count
790
Registration Number
NCT06039449
Locations
🇺🇸

INVIVYD Investigative Site, Dallas, Texas, United States

Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments

Conditions
COVID-19
First Posted Date
2023-08-22
Last Posted Date
2024-06-03
Lead Sponsor
Invivyd, Inc.
Registration Number
NCT06004128

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants

Phase 1
Completed
Conditions
COVID-19
Interventions
Other: Placebo
First Posted Date
2023-03-30
Last Posted Date
2024-05-31
Lead Sponsor
Invivyd, Inc.
Target Recruit Count
30
Registration Number
NCT05791318
Locations
🇦🇺

Linear Clinical Research, Joondalup, Western Australia, Australia

Evaluation of ADG20 for the Prevention of COVID-19

Phase 2
Terminated
Conditions
COVID-19
Interventions
Drug: Placebo
First Posted Date
2021-04-26
Last Posted Date
2024-08-20
Lead Sponsor
Invivyd, Inc.
Target Recruit Count
2582
Registration Number
NCT04859517
Locations
🇺🇦

Invivyd Investigative Site, Kyiv, Ukraine

🇺🇦

Adagio Investigative Site, Kyiv, Ukraine

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News

Invivyd Forms SPEAR Study Group to Investigate Monoclonal Antibody Therapy for Long COVID

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.

Invivyd's PEMGARDA Shows 84% COVID-19 Prevention Efficacy in Landmark Phase 3 Trial

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).

Upstream Bio Appoints Stacy Price as Chief Technology Officer to Advance Verekitug Development

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.

Invivyd Challenges FDA with Citizen Petition to Prioritize Monoclonal Antibodies for COVID-19 Prevention

Invivyd has submitted a Citizen Petition urging the FDA to reevaluate COVID-19 prevention strategies, emphasizing the need for monoclonal antibodies alongside vaccines in the endemic phase of the virus.

Invivyd Initiates Measles Monoclonal Antibody Discovery Program to Address Critical Treatment Gap

Invivyd has launched a discovery program for a measles monoclonal antibody (mAb) in response to direct requests from healthcare providers treating active measles cases and managing outbreaks.

Invivyd Secures $30M Non-dilutive Loan Facility to Advance COVID-19 Antibody Pipeline

Invivyd has signed a $30 million term loan facility with Silicon Valley Bank, providing non-dilutive capital access contingent on meeting specific milestones and conditions.

FDA Denies Invivyd's EUA Expansion Request for COVID-19 Antibody Pemgarda

The FDA has rejected Invivyd's application to expand Pemgarda's emergency use authorization for treating mild to moderate COVID-19 in immunocompromised patients without alternative treatment options.

Invivyd's VYD2311 Shows Promise as COVID-19 Protection Alternative in Phase 1/2 Trial

Invivyd's VYD2311 demonstrates positive safety and pharmacokinetic profiles in an ongoing Phase 1/2 clinical trial, with complete enrollment and dosing.

Invivyd's Pemgarda Shows Continued Neutralizing Activity Against SARS-CoV-2 Variant XEC

Invivyd's PEMGARDA (pemivibart) demonstrates consistent neutralizing activity against the dominant SARS-CoV-2 variant XEC in new in vitro data.

Invivyd's Pemivibart Shows Long-Term COVID-19 Protection in CANOPY Trial

Invivyd's CANOPY phase 3 trial data demonstrates pemivibart's efficacy as pre-exposure prophylaxis (PrEP) for COVID-19, including protection against recent JN.1 sublineages.

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