Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial
Invivyd, Inc. announces interim exploratory COVID-19 clinical event data for VYD222, an investigational monoclonal antibody for pre-exposure prophylaxis. The data from the Phase 3 CANOPY trial show a potential signal of clinical protection from symptomatic COVID-19. The company plans to further analyze the relationship between serum virus neutralizing antibody titers and clinical efficacy in future trials.
The interim exploratory data from Invivyd's CANOPY Phase 3 clinical trial presents an interesting perspective on the potential efficacy of VYD222, a monoclonal antibody designed for pre-exposure prophylaxis against COVID-19. The distinction made between participants with prior immunity and those without is noteworthy. Historically, monoclonal antibody trials have focused on naïve populations, but the inclusion of individuals with pre-existing immunity could suggest a shift in the understanding of therapeutic efficacy in a more varied demographic.
The data, while not yet conclusive, indicate a potential correlation between serum virus neutralizing antibody (sVNA) titers and clinical protection. This could have implications for future clinical trial designs and the development of monoclonal antibodies as a preventative measure. The analysis of symptomatic COVID-19 events as a secondary endpoint underscores the exploratory nature of this data, which does not directly impact regulatory filings but does provide a foundation for future research and development strategies.
The reported rates of symptomatic COVID-19 in the CANOPY trial's cohorts offer preliminary insights into the real-world effectiveness of VYD222 across different levels of immune compromise. The low incidence of symptomatic cases in both cohorts, especially when compared to the placebo group, raises questions about the potential role of VYD222 in broader prophylactic strategies. However, these findings must be interpreted with caution, as the data are exploratory and the full dataset from the Day 180 analysis is pending.
Understanding the dynamics of sVNA titers in relation to clinical outcomes is important for public health strategies. These interim results could influence future vaccination policies and the development of targeted prophylactic treatments for individuals at high risk of exposure or with compromised immune systems. The ongoing monitoring of these participants will be essential in determining the long-term protective effects of VYD222 and its possible integration into existing prevention protocols.
From an industry perspective, Invivyd's interim data release is a strategic move that may position the company as a thought leader in the evolving landscape of COVID-19 prophylaxis. The emphasis on the relationship between neutralizing titers and protection is a step towards more personalized healthcare solutions. While the immediate financial impact on Invivyd's stock may be limited due to the exploratory status of the findings, the long-term potential of VYD222 to meet unaddressed needs in immune-compromised populations could be significant.
Investors should monitor the progress of the CANOPY trial closely, as the Day 180 results will provide a more comprehensive understanding of VYD222's efficacy and safety profile. Positive outcomes could lead to increased investor confidence and potentially drive the company's valuation. However, the biotech sector is highly volatile and the eventual market success of VYD222 will depend on a variety of factors including competitive products, market demand and the regulatory landscape.
03/22/2024 - 03:28 PM
Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work Today’s update on Day 67 and Day 90 event rates is the first of two planned public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180 Further defining the relationship between serum virus neutralizing antibody titers and clinical protection that prospectively builds on published data is an anticipated goal of future clinical trials WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. The data announced today from the ongoing Phase 3 CANOPY clinical trial reflect and add further to the initial potential signal of clinical protection from symptomatic COVID-19 shared in December 2023, and may be useful in updating prior published work that analyzed the relationships between serum virus neutralizing antibody (sVNA) titers and protection in patients who had no prior exposure to vaccination or natural infection.1
“While these interim clinical efficacy data are exploratory and not part of the primary immunobridging endpoint of the CANOPY clinical trial, we believe they further our efforts to understand the relationship between sVNA titers and clinical efficacy in individuals who have some level of vaccine- or infection-induced immunity,” said Dave Hering, Chief Executive Officer. “As we continue to build out our company and advance the science describing monoclonal antibody pre-exposure prophylaxis (PrEP), we believe we can incorporate these findings into future prospectively designed clinical studies that seek to establish formal relationships between neutralizing titers and protection. Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection. By contrast, studies of prior authorized COVID-19 PrEP mAbs largely relied on participants required by protocol to be naïve to vaccination or prior infection2 . As such, these people would presumably have no baseline titers. We continue to explore how measured titers compare with calculated titers and look to assess if higher levels of protection in future studies may be possible with lower levels of additional titers conferred from mAbs.”
The ongoing CANOPY Phase 3 clinical trial is designed to evaluate the safety and tolerability of VYD222 and to assess immunobridging from VYD222 to certain historical data from the company’s previous Phase 2/3 clinical trial of adintrevimab (ADG20) for the prevention of symptomatic COVID-19 (EVADE). Symptomatic COVID-19 event collection in the CANOPY clinical trial is a secondary exploratory endpoint designed to allow Invivyd to contemplate further discovery and development work only. The CANOPY clinical trial enrolled participants in two cohorts. Cohort A is a single-arm, open-label trial in adults who have moderate-to-severe immune compromise including complex underlying medical conditions (n=306). Cohort B is a randomized, placebo-controlled cohort that enrolled adults without moderate-to-severe immune compromise who are at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings. All CANOPY Cohort A participants received VYD222 administered via intravenous (IV) infusion. Cohort B participants were randomized 2:1 to receive VYD222 or placebo administered via IV infusion.
Updated Findings
As previously disclosed by the company in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90. Beyond today’s update, additional cases of COVID-19 have occurred in Cohorts A and B post Day 90. These data are planned to be analyzed at Day 180 and presented when available.
Cohort B (Randomized, placebo-controlled cohort without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data):
As of December 1, 2023 Through Day 90 VYD222 0% (0/322)0.3% (1/314)Placebo 3% (5/162)5% (8/159)
Cohort A (Open-label cohort with moderate-to-severe immune compromise) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data):
As of December 1, 2023 Through Day 90 VYD222 0% (0/306)1% (3/298)
Additional COVID-19 events have occurred in Cohort A (unblinded) and Cohort B (randomized, not yet analyzed) post Day 90, but the company has not yet analyzed the data. Invivyd plans to provide a Day 180 update and a more complete analysis of the observed relationships between sVNA titers, both calculated and measured, and events of confirmed symptomatic COVID-19 when these data are available.
About VYD222 in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against various pre-Omicron and Omicron variants, including JN.1. VYD222 was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.
About Invivyd https://invivyd.com/ to learn more.
References
Schmidt, Pete et al. “Antibody-mediated protection against symptomatic COVID-19 can be achieved at low serum neutralizing titers.” Sci. Transl. Med.15, eadg2783 (2023); Follmann, Dean et al. “Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration.” Nature communications vol. 14,1 3605. 17 Jun. 2023. Ison, Michael, et al. “Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE).” Open Forum Infectious Diseases, Volume 10, Issue 7, July 2023; Levin, Myron J et al. “Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19.” The New England Journal of Medicine vol. 386,23 (2022): 2188-2200. Cautionary Note Regarding Forward Looking Statements in vitro neutralizing activity of VYD222 against major SARS-CoV-2 variants; the company’s mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2; the ability of the company to leverage its INVYMAB platform approach to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications; the company’s business strategies and objectives; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing and progress of the company’s discovery, preclinical and clinical development activities; the risk that results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in preclinical studies; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether VYD222 or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the company’s ability to leverage its INVYMAB platform approach to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases; the uncertainties and timing of the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company’s product candidates; changes in the regulatory environment; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
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Contacts:
Scott Youngsyoung@invivyd.com
Gabriella Linville-Englergengler@invivyd.com
What is the purpose of the Phase 3 CANOPY trial by Invivyd, Inc.?
The CANOPY trial aims to evaluate the safety and tolerability of VYD222 and assess immunobridging from VYD222 to historical data from a previous Phase 2/3 trial of adintrevimab (ADG20) for preventing symptomatic COVID-19.
What are the findings of the interim exploratory COVID-19 clinical event data for VYD222?
The data show a potential signal of clinical protection from symptomatic COVID-19, with further analysis planned to understand the relationship between serum virus neutralizing antibody titers and clinical efficacy.
What are the proportions of participants with RT-PCR-confirmed symptomatic COVID-19 in Cohorts A and B of the CANOPY trial?
In Cohort A (moderate-to-severe immune compromise), VYD222 had 0% cases through Day 90, while in Cohort B (at risk of acquiring SARS-CoV-2), VYD222 had 0.3% cases through Day 90.
What are the plans for further data analysis by Invivyd regarding COVID-19 events in the CANOPY trial?
Invivyd plans to provide a Day 180 update and a more comprehensive analysis of the relationships between serum virus neutralizing antibody titers and confirmed symptomatic COVID-19 events.
