Adintrevimab is being evaluated in two separate Phase 2/3 clinical trials: EVADE and STAMP. EVADE is a global Phase 2/3 clinical trial evaluating adintrevimab as a prevention for COVID-19 in both the post-exposure and pre-exposure settings. STAMP is a global Phase 2/3 clinical trial evaluating adintrevimab as a treatment for mild to moderate COVID-19. Due to the emergence and global spread of the Omicron variant, against which adintrevimab has reduced in vitro neutralization potency compared to prior variants, enrollment in both EVADE and STAMP was paused on January 11, 2022, and preliminary safety and efficacy data were evaluated.
PHASE 2/3 EVADE TRIAL OF ADINTREVIMAB FOR THE PREVENTION OF COVID-19
EVADE is a global, multi-center, double-blind, placebo-controlled Phase 2/3 clinical trial to evaluate adintrevimab administered at 300mg IM in two independent cohorts for the prevention of COVID-19. The study includes a pre-exposure prophylaxis (PrEP) cohort and a post-exposure prophylaxis (PEP) cohort.
The PEP cohort is designed to assess the safety and efficacy of adintrevimab to placebo for the prevention of COVID-19 after known, recent exposure to an individual with laboratory confirmed SARS-CoV-2 infection.
The PrEP cohort is designed to assess the efficacy and safety of adintrevimab compared to placebo in individuals who are at increased risk for SARS-CoV-2 infection due to occupational, housing, or recreational situations, and in individuals who are at increased risk of poor vaccine response, including individuals with compromised immune systems or other co-morbidities.
STAMP PHASE 2/3 STAMP TRIAL OF ADINTREVIMAB FOR THE TREATMENT OF COVID-19
The STAMP trial is designed as a global, multi-center, double-blind, randomized, placebo-controlled clinical trial to evaluate efficacy and safety of adintrevimab at a dose of 300mg IM in patients with mild to moderate COVID-19 who are at high risk for disease progression. The primary objective of STAMP is to compare the efficacy of a single intramuscular dose of adintrevimab to placebo in the prevention of COVID-19 related hospitalizations and all-cause death.
Results from Phase 2/3 STAMP and EVADE Studies of Adintrevimab for the Prevention or Treatment of COVID-19
In pre-exposure and post-exposure prophylaxis, adintrevimab was associated with 71% and 75% relative risk reductions compared to placebo, respectively, in the prevention of reverse transcription-polymerase chain reaction (“RT-PCR”) confirmed symptomatic COVID-19. In an exploratory analysis of patients exposed to the Omicron variant (the “post-Omicron group”) in pre-exposure prophylaxis, adintrevimab was associated with a clinically meaningful reduction in the risk of developing RT-PCR confirmed symptomatic COVID-19 compared with placebo.
In treatment, adintrevimab was associated with a 66% relative risk reduction compared to placebo in the incidence COVID-19 related hospitalization or all cause death through Day 29 in the pre-Omicron group. In patients treated within three days of symptom onset, adintrevimab was associated with a reduced risk of COVID-19 hospitalization or death from any cause through Day 29 by 74% compared to placebo.
A preliminary analysis of available safety data in each trial revealed a safety profile similar to that of placebo for adintrevimab.
For more information, please visit clinicaltrials.gov.
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EXPANDED ACCESS POLICY
Invivyd, Inc. is advancing the latest discoveries to develop safe and effective monoclonal antibodies that have the potential to prevent COVID-19, and to treat mild to moderate COVID-19. 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 that permits access to 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
Invivyd’s 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 drug products, including our lead monoclonal antibody investigational agent, adintrevimab, 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.