ADVANCING A STREAM OF INNOVATIVE CANDIDATES

Overview

With our INVYMAB™ platform approach, we aim to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats. Leveraging state-of-the-art viral surveillance, predictive modeling, and advanced antibody engineering techniques, we have generated a pipeline of therapeutic candidates designed to protect vulnerable people from serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications.

Development Status
Programs Platform Indication(s) Discovery/ Preclinical Ind-enabling Phase 1 Phase 2 Phase 3 Status
SARS-COV-2
VYD222 mAb Pre-exposure prophylaxis (prevention)
Reported positive initial Ph 3 results and submitted EUA request to FDA
COVID Candidate #2 mAb Prevention or Treatment
Engineering variant matching
COVID Candidate #3 mAb Prevention or Treatment
Engineering variant matching
COVID Candidate #4 mAb Prevention or Treatment
Engineering variant matching
Adintrevimab mAb Prevention
Trials concluded, EUA filing dependent on variant susceptibility
Adintrevimab mAb Treatment
Other Viruses
Influenza mAb Combination Prevention
Early discovery

COVID-19

About the unmet need for immunocompromised people

Without a fully functioning immune system, many immunocompromised people have an impaired response to vaccines and generate less protection against severe COVID-19 outcomes than immunocompetent people.1-2

COVID-19 has a disproportionate impact on immunocompromised (IC) people

In a recent study, IC people accounted for 3.9% of the study population, but 24% of COVID-19 deaths—even though >80% of the IC population had received ≥3 COVID-19 vaccines4

  • This vulnerable population includes, among others3:
    • Stem cell transplant recipients
    • Solid organ transplant recipients
    • People with hematologic cancers, like leukemia and lymphoma, as well as people with forms of cancer that require treatments that weaken the immune system, such as chemotherapy
    • People with primary immunodeficiency diseases
    • People who are taking immunosuppressive drugs, for example for autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, or inflammatory bowel disease
  • Immunocompromised people require an approach to COVID-19 prevention that does not rely on their body’s own immune system to generate protection, as is required with vaccines

COVID-19 has a disproportionate impact on immunocompromised (IC) people

In a recent study, IC people accounted for 3.9% of the study population, but 24% of COVID-19 deaths—even though >80% of the IC population had received ≥3 COVID-19 vaccines4

Sources: 1. Lee BMJ 2022; 2. Link-Gelles R MMWR Morb Mortal Wkly Rep 2023; 3. Centers for Disease Control and Prevention. People Who Are Immunocompromised. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-who-are-immunocompromised.html; 4. Evans Lancet Reg 2023

About VYD222 and anticipated follow-on candidates

On January 3, 2024, Invivyd announced that it has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody candidate, for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised adults and adolescents. The EUA submission was based on positive initial results from the CANOPY Phase 3 pivotal clinical trial of VYD222, as well as ongoing in vitro neutralization activity against relevant variants such as JN.1.

Beyond VYD222, we have multiple anti-SARS-CoV-2 mAb candidates in discovery and pre-clinical characterization. This robust pipeline reflects our strategy to continuously discover and engineer new candidates that can be leveraged to keep pace with viral evolution.

Healthy grandmother with grandchildren on a beach in winter. Antibodies gently float up from the horizon

Influenza

Influenza (flu) can pose a serious threat for certain vulnerable populations, even with the availability of seasonal flu vaccines. This high-risk population includes, among other groups, the elderly, people with certain chronic medical conditions, and individuals who are immunocompromised. With hospitalization and death occurring mainly in high-risk groups, there is a need for new medicines, such as monoclonal antibodies, that can help protect vulnerable populations from influenza.1

Leveraging our collaborations and discovery platform, we have lead molecules targeting influenza that are in the early discovery phase.

Source: 1. World Health Organization. Influenza (Seasonal) Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)

Clinical trials

We are currently conducting the CANOPY Phase 3 pivotal clinical trial, a study designed to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise (Cohort A) and in participants at risk of exposure to SARS-CoV-2 (Cohort B). In November 2023, Invivyd announced that it had completed enrollment in Cohort A and B. To learn more about the trial, visit ClinicalTrials.gov – NCT06039449.

If you are interested in becoming an investigator or study site for an upcoming Invivyd clinical trial, please click here to complete a brief questionnaire.
Scientist working in a lab developing antibody-based therapies that target emerging viral threats
If you are interested in becoming an investigator or study site for an upcoming Invivyd clinical trial, please click here to complete a brief questionnaire.
Scientist working in a lab developing antibody-based therapies that target emerging viral threats

Expanded Access Policy

Invivyd, Inc. is generating a robust pipeline of product candidates which could be used in the prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications. We are committed to bringing these important and innovative therapies to individuals who may benefit from them, and we embrace collaboration with individuals, families, physicians, researchers, and regulatory authorities to accomplish this goal and our mission.

Evaluation of an investigational therapy in clinical trials is the optimal way to collect the safety and efficacy information necessary to enable regulatory authority review and, ultimately, to support product approval and subsequent wider accessibility in the most efficient and expedient manner possible. Participation in a clinical trial is often the best way for an individual to access an investigational therapy. At Invivyd, our goal is to expeditiously carry out robust clinical trials to generate the safety and efficacy data to support regulatory approvals, thereby providing the broadest possible access to individuals who might benefit from the therapy.

We understand that individuals and families may be interested in accessing Invivyd’s investigational therapies prior to regulatory authorization and outside of the clinical trial setting through an expanded access program (sometimes referred to as “compassionate use” or “early access”). Currently, we do not have an expanded access program for our investigational products prior to regulatory authority (such as FDA) authorization. Wherever possible, use of an investigational product as part of a clinical trial is preferable because clinical trials generate data regarding the efficacy and safety of these products. Physicians and other health care providers, individuals, and caregivers interested in learning more about Invivyd’s investigational therapies should contact Invivyd at ExpandedAccess@Invivyd.com. We anticipate acknowledging receipt of inquiries sent to this email within five business days. Additional information regarding our clinical trials may be accessed on www.clinicaltrials.gov.

Statement on Stem Cell Research

Our vision is to discover, develop, and commercialize antibody-based solutions not only for the current COVID-19 pandemic, but also for other infectious diseases. To enable this vision, we are focused on advancing potent, broadly neutralizing antibodies that target multiple conserved epitopes including across members of the coronavirus family. Critical to the successful development of therapeutic programs in the biopharma industry is early-stage research to help us understand the complexities of human biology, how diseases are manifested, and what therapeutic approaches may be taken to address the underlying causes of those diseases.

As is the case with many biopharma companies, at Invivyd, we use a wide variety of research tools and technologies to help us discover and develop new treatments. Stem cells are one such tool, and in a very limited capacity, human embryonic stem cells that meet the highest ethical standards set by leading scientific authorities are used during the earliest stages of our research. This approach is essential to the field of drug discovery and development, providing important insights that have led and will continue to lead to the creation of new medicines that positively impact global health.

To support the manufacturing of our drug products, we have established a long-term agreement with an industry-leading contract manufacturing organization to produce drug product for both our ongoing clinical trials and future commercial supply. Our current product candidates, including our lead monoclonal antibody candidate, VYD222, are produced from a commonly used recombinant mammalian cell line, and at no point in our manufacturing process are human embryonic stem cells used.

As a company, Invivyd honors a commitment to advancing products in an ethical and scientifically responsible manner, particularly while navigating the complex issues inherent in the biopharma industry. All of our research and development, including that which is conducted using stem cells, adheres to local government standards and regulations for the country it is conducted in, and we require the same level of adherence by all of our collaborators. In addition, we are continuously evaluating our practices to ensure they abide by the highest standards of scientific and bioethical integrity. We are dedicated to maintaining this rigorous approach to both our research and manufacturing so that we may advance medicines that combat global issues, such as the COVID-19 pandemic, and meaningfully impact people around the world.