OUR APPROACH

At Invivyd, we are developing antibodies to transcend the limits of naturally occurring immunity to provide superior protection from viral diseases, beginning with COVID-19. We are exploring the vast universe of antibodies beyond the common immune repertoire to identify those with high likelihood for lasting utility.

Our technology works at the intersection of evolutionary virology, predictive modeling, and antibody engineering, with the potential to create high-quality, long-lasting antibodies with a high barrier to viral escape. Our products can be tuned to improve potency, breadth of neutralization, and half-life, and can be developed for use in both prevention and treatment of disease.

With our powerful proprietary platform approach, we are generating a pipeline of next-generation engineered antibodies for the prevention and treatment of viral infectious diseases, starting with SARS-CoV-2. Our discovery efforts in this disease area are focused on broadly neutralizing antibodies that target conserved epitopes across multiple members of the coronavirus family.

CORONAVIRUSES: A CONTINUED GLOBAL BURDEN

Coronaviruses comprise a large family of viruses that are grouped into four genera: alphacoronavirus, betacoronavirus, gammacoronavirus and deltacoronavirus. Over the past 20 years, three pathogenic novel betacoronaviruses have spilled over into the human population from animal reservoirs to cause outbreaks of deadly pneumonia, including SARS-CoV-2, SARS and MERS.

COVID-19, the disease caused by SARS-CoV-2 and its variants, has given rise to a global pandemic that swept rapidly throughout the world in 2020 and 2021 and continues to disrupt global supply chains and cause significant global burden.

SARS-CoV-2 and the human antibody response are in a perpetual cycle of co-evolution. Weak antibody responses cannot suppress the virus completely, allowing repeat infection, mutation‚ and the rise of new variants that can escape established immunity.

OUR SOLUTION

We believe that engineered antibodies that robustly and durably protect humans from SARS-CoV-2 have the following characteristics:

  • Provide superior protection compared to human antibodies induced by vaccination and infection
  • Highly potent and broadly neutralizing activity to address SARS-CoV-2, including variants of concern
  • Easily accessible and patient friendly with a single outpatient administration
  • Can be deployed in advance to prevent disease, or once sick to treat disease

Invivyd’s discovery technology and platform are designed to overcome the challenges of viral evolution through ongoing innovation. With our platform approach, we are determined to change the paradigm for managing viral infections and powering the return to normal by delivering rapid and lasting antibody immunity to protect the general public and ensure vulnerable populations are never left behind.

Pipeline

Leveraging our technology platform, we have built a robust pipeline of antibody candidates for the prevention and treatment of COVID-19, including NVD200, a novel antibody cocktail entering Phase 1 clinical trial in Q1 2023. NVD200 is a combination of two monoclonal antibodies with demonstrated in vitro neutralizing activity against Omicron variants BA.1, BA.2, BA.4, BA.5,  and BA.2.75, as well as pre-Omicron VOCs and the more divergent SARS-CoV-1.  NVD200 has been engineered, optimizing for potency and breadth of coverage, as well as to provide a higher probability of retaining its utility for a longer duration in an evolving viral landscape. The two antibodies in the combination target non-overlapping epitopes on the SARS-CoV-2 virus, and both sites are under minimal immune pressure because they are not readily targeted by the common human immune repertoire. We believe this will reduce the likelihood of immune escape. Not only does this provide an attractive option for treatment of disease, but by engineering our antibodies for extended half-life, a single administration has potential to offer much longer lasting protection than can be achieved with vaccines.

Invivyd’s most advanced pipeline candidate, adintrevimab (ADG20), was shown to provide neutralizing protection against SARS-CoV-2 for all variants of concern until the emergence of the Omicron BA.2 strain and its sublineages. Monoclonal antibodies have shown both increased and decreased activity against variants of SARS-CoV-2 over time. Given the broadly neutralizing attributes of adintrevimab, Invivyd’s monitoring and assessment of potential variant mutations suggest that a future variant may arise for which adintrevimab could provide protection. Adintrevimab is ready for regulatory review and commercial readiness activities are underway. Our stockpile of more than 700,000 doses could be deployed in as little as 60 days after authorization.

But we won’t stop there. We vigilantly monitor the evolving viral variants and continuously identify multiple new antibody candidates that provide broad in vitro neutralizing activity against past, current, and potential future variants of concern. Our goal is to always be innovating to match whatever challenges the virus presents with novel products for prevention and treatment of disease.

ADG20 is currently being evaluated in two global Phase 2/3 clinical trials‚ STAMP and EVADE, for the treatment and prevention of COVID-19, respectively. ADG20 is not approved for use in any country. The safety and efficacy of ADG20 have not been established.

Publications & Presentations

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ADG20, a half-life–extended monoclonal antibody in development for the prevention and treatment of COVID-19, demonstrated broad in vitro neutralisation against SARS-CoV-2 variants

ECCMID 2022

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Population pharmacokinetics of ADG20, an extended–half-life monoclonal antibody being developed for the treatment and prevention of COVID-19

ECCMID 2022

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Results from the Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Adintrevimab (ADG20) in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)

ASM Microbe 2022

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Broad and Potent In Vitro Neutralization of SARS-CoV-2 Variants by ADG20, a Half-Life–Extended Monoclonal Antibody in Development for the Prevention and Treatment of COVID-19

 ISIRV-WHO 2021

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Evaluating the Safety, Tolerability, and Pharmacokinetics of ADG20, a Half-Life–Extended Monoclonal Antibody (mAb) in Development for the Prevention and Treatment of COVID-19: a Preliminary Analysis of a Randomized Phase 1 Study

 ISIRV-WHO 2021

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A Whole-Body Quantitative System Pharmacology Physiologically Based Pharmacokinetic Model That a Priori Predicts Pharmacokinetics of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of COVID-19

IDWeek 2021

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A Whole-Body Quantitative System Pharmacology Physiologically Based Pharmacokinetic Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)

IDWeek 2021

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Use of a Whole-Body Quantitative System Pharmacology Physiologically Based Pharmacokinetic Model to Support ADG20 Dose Selection for the Prevention of Coronavirus Disease (COVID-19)

IDWeek 2021

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Preliminary Results From a Phase 1 Single Ascending-Dose Study Assessing Safety, Pharmacokinetic Profile, and Serum Viral Neutralizing Antibody Titers of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of COVID-19 

IDWeek 2021

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The ADG20 human monoclonal antibody binds with high affinity and neutralises a wide range of SARS CoV 2 variants and zoonotic sarbecoviruses

ECCMID 2021

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Prophylactic administration of the monoclonal antibody ADG20 provides potent protection against SARS-CoV-2 in rodent and non-human primate models of COVID-19

ECCMID 2021

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Developing therapeutic approaches for twenty-first-century emerging infectious viral diseases

Nature Medicine

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Prolonged evolution of the human B cell response to SARS-CoV-2 infection

Science Immunology

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Structural Basis of Zika Virus Specific Neutralization in Subsequent Flavivirus Infections

MDPI

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Rational Vaccine Design in the Time of COVID-19

Cell Host Microbe

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Broad and potent activity against SARS-like viruses by an engineered human monoclonal antibody

Science

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An Engineered Antibody with Broad Protective Efficacy in Murine Models of SARS and COVID-19

BioRxiv

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Wec AZ et al. Broad neutralization of SARS-related antibodies by human monoclonal antibodies. Science. 2020 Jun 15.

Science

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Wec AZ et al. Longitudinal dynamics of the human B cell response to the yellow fever 17D vaccine. Proc Natl Acad Sci U S A. 2020 Mar 24;117(12):6675-6685.

Proceedings of the National Academy of Sciences (PNAS)

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Shehata L et al. Systematic comparison of respiratory syncytial virus-induced memory B cell responses in two anatomical compartments. Nat Commun. 2019 Mar 8; 10(1):1126.

Nature Communications

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West BR et al. Structural basis of broad ebolavirus neutralization by a human survivor antibody. Nat Struct Mol Biol. 2019 Mar; 26(3):204-212.

Nature Structural and Molecular Biology

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Bornholdt ZA et al. A Two-Antibody Pan-Ebolavirus Cocktail Confers Broad Therapeutic Protection in Ferrets and Nonhuman Primates. Cell Host Microbe. 2019 Jan 9; 25(1):49-58.e5.

Cell Host and Microbe

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Wec AZ et al. Development of a Human Antibody Cocktail that Deploys Multiple Functions to Confer Pan-Ebolavirus Protection. Cell Host Microbe. 2019 Jan 9; 25(1):39-48.e5.

Cell Host and Microbe

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Saphire EO et al. Systematic Analysis of Monoclonal Antibodies against Ebola Virus GP Defines Features that Contribute to Protection (2018). Cell. Aug 09; 174(4):938-952.

Cell

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Goodwin E et al. Infants Infected with Respiratory Syncytial Virus Generate Potent Neutralizing Antibodies that Lack Somatic Hypermutation (2018). Immunity. Feb 20; 48(2):339-349

Immunity 

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Walker LM et al. Passive immunotherapy of viral infections: ‘super-antibodies’ enter the fray (2018). Nat Rev Immunol. May; 18(5):297-308.

Nature Reviews Immunology

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Rogers TF et al. Zika virus activates de novo and cross-reactive memory B cell responses in dengue-experienced donors (2017). Sci Immunol. Aug 18; 2(14). 

Science Immunology

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Wec AZ et al. Antibodies from a Human Survivor Define Sites of Vulnerability for Broad Protection against Ebolaviruses (2017). Cell. May 18; 169(5):878-890.

Cell

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Gilman MS et al. Rapid profiling of RSV antibody repertoires from the memory B cells of naturally infected adult donors (2016). Sci Immunol. Dec 16; 1(6).

Science Immunology

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Badarau A et al. Context matters: The importance of dimerization-induced conformation of the LukGH leukocidin of Staphylococcus aureus for the generation of neutralizing antibodies (2016). MAbs. Jul 28:0.

mAbs

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Bornholdt ZA et al. Isolation of potent neutralizing antibodies from a survivor of the 2014 Ebola virus outbreak (2016). Science. Mar 4;351(6277):1078-83.

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Walker LM et al. Broad neutralization coverage of HIV by multiple highly potent antibodies (2011). Nature. Aug 17;477(7365):466-470.

Nature

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Walker LM et al. Rational antibody-based HIV-1 vaccine design: current approaches and future directions (2010). Curr Opin Immunol. Jun; 22(3):358-66. 

Science Direct

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Walker LM et al. Broad and Potent Neutralizing Antibodies from an African Donor Reveal a New HIV-1 Vaccine Target (2009). Science. 326(5950):285-9.  

Science