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. Our robust pipeline reflects our strategy to continuously discover and engineer new candidates that can be leveraged to keep pace with viral evolution.
| Programs | Target | Preclinical | Phase 1 | Phase 2 | Phase 3 | Authorized | Status | |
|---|---|---|---|---|---|---|---|---|
| COVID-19 | ||||||||
| Pemivibart | Pre-exposure prophylaxis (prevention) |
|
Received emergency use authorization (EUA) from the U.S. FDA in March 2024 | |||||
| VYD2311 | Prevention or Treatment |
|
Preparing for initiation of IND-enabling studies | |||||
| COVID Candidate #3 | Prevention or Treatment |
|
Engineering variant matching | |||||
| COVID Candidate #4 | Prevention or Treatment |
|
Engineering variant matching | |||||
| Adintrevimab | Prevention of treatment |
|
Trials concluded, EUA filing dependent on variant susceptibility | |||||
| Other Viruses | ||||||||
| Influenza | 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
- Medical conditions or treatments that may result in moderate to severe immune compromise and an impaired immune response to COVID-19 vaccination include3:
- Active treatment for solid tumor and hematologic malignancies
- Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status
- Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
- Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant
- Moderate or severe primary immunodeficiency
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids, alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory
- 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
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.
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 clinical trials and commercial supply. Our current product and product candidates 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.