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Invivyd to Present Multiple Posters Highlighting Clinical Data from Adintrevimab During ID Week 2022
来源: Nasdaq GlobeNewswire / 12 10月 2022 16:01:00 America/New_York
WALTHAM, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Invivyd, (Nasdaq: IVVD), formerly Adagio Therapeutics (Nasdaq: ADGI), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases announced today that it will have four poster presentations at ID Week 2022. The posters will share findings from several studies surrounding adintrevimab, including data from the Phase 1 and Phase 2/3 clinical trials.
Poster details for the meeting are as follows. The complete program can be accessed at the ID Week 2022 website at www.idweek.org.
Poster Number: 226
Title: Higher Doses of Adintrevimab, an Extended Half-Life Monoclonal Antibody, for the Treatment and Prevention of COVID-19: Preliminary Results from a Phase 1 Single Ascending-Dose Study
Poster Session: Clinical Trials
Date and Time: Thursday, October 20, 2022 12:15 PM – 1:30 PM US EST
Location: Hall B+CPoster Number: 591
Title: Adintrevimab (ADI) Population Pharmacokinetics (PPK) in Phase 1 and Phase 2/3 COVID-19 Prevention and Treatment Study Participants
Poster Session: PK/PD Studies
Date and Time: Thursday, October 20, 2022 12:15 PM – 1:30 PM US EST
Location: Hall B+CPoster Number: 1113
Title: Clinical and Virologic Outcomes with Early Adintrevimab (ADI) Monoclonal Antibody Therapy in Mild and Moderate COVID-19
Poster Session: COVID-19: Treatment
Date and Time: Friday, October 21, 2022 12:15 PM – 1:30 PM US EST
Location: Hall B+CPoster Number: 1132
Title: Clinical Integrated Quantitative Systems Pharmacology (QSP) Characterizing Viral Dynamics After Intramuscular (IM) Adintrevimab (ADI) Administration in Participants with Mild to Moderate Coronavirus Disease (COVID-19)
Poster Session: COVID-19: Treatment
Date and Time: Friday, October 21, 2022 12:15 PM – 1:30 PM US EST
Location: Hall B+CAbout Adintrevimab
Adintrevimab (ADG20) is an engineered monoclonal antibody developed for the prevention and treatment of COVID-19. Adintrevimab showed neutralizing activity against all variants of concern through BA1.1, and in Phase 2/3 clinical trials, adintrevimab was shown to provide protection against SARS-CoV-2 Delta and Omicron BA.1 variants and to be well tolerated with no safety signals identified through a minimum of 6 months follow-up across all cohorts. One of the antibodies in NVD200, Invivyd’s first combination product candidate, is a re-engineered version of adintrevimab with in vitro activity against all SARS-CoV-2 variants assessed to date including emerging Omicron sublineages (e.g. BA.275, BA.275.2, BA.4.6, BN1, and BJ1). Given the broadly neutralizing attributes of adintrevimab, a future variant may arise for which adintrevimab could provide protection. Adintrevimab is an investigational monoclonal antibody that is not approved for use in any country. The safety and efficacy of adintrevimab have not been established.About Invivyd
Invivyd (Nasdaq: IVVD) is a biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases. The company is developing antibodies to transcend the limits of naturally occurring immunity and provide superior protection from viral diseases, beginning with COVID-19. Invivyd’s technology works at the intersection of evolutionary virology, predictive modeling, and antibody engineering, and is designed to identify high-quality, long-lasting antibodies with a high barrier to viral escape. The company is generating a robust pipeline of products for use in both prevention and treatment of disease. NVD200, Invivyd’s first antibody combination product for COVID-19, is expected to enter the clinic in Q1 2023. Adintrevimab is not approved for use in any country. The safety and efficacy of adintrevimab have not been established. The company also has multiple discovery stage candidates for the prevention of seasonal influenza. Visit www.invivyd.com to learn more.Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the future of the COVID-19 landscape including the expectation of continued evolution and emergence of new variants and subvariants; our ongoing research and clinical development plans and the timing thereof; our plans to advance adintrevimab, NVD200, or other early stage candidates as a potential prophylaxis and treatment option for COVID-19, including disease caused by most variants, as either a single or combination agent, including our intention to initiate clinical development of NVD200 in the first quarter of 2023; the potential for adintrevimab and NVD200 to demonstrate activity against predominant SARS-CoV-2 variant(s) in the U.S. and globally; our plans, technology and resources to develop therapeutic or preventative options for other infectious diseases, such as additional coronaviruses and seasonal influenza, in the U.S. and globally; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the impacts of the COVID-19 pandemic on our business and those of our collaborators, our clinical trials and our financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of adintrevimab, NVD200, or other pipeline candidates or combination of candidates based on neutralizing activity in pre-clinical studies; variability of results in models used to predict activity against SARS-CoV-2 variants of concern; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process, including the outcome of our discussions with regulatory authorities concerning our clinical trials; whether adintrevimab, NVD200, or any other pipeline candidate or combination of candidates is able to demonstrate activity against predominant SARS-CoV-2 variant(s) in the U.S. and globally; whether we are able to successfully submit an emergency use authorization in the future, and the outcome of any such emergency use authorization submission; whether research and development efforts will improve efficacy of adintrevimab against predominant variants or identify additional monoclonal antibodies or combination of antibodies for the prevention and treatment of COVID-19 and other infectious diseases; whether research and development efforts will identify and result in safe and effective therapeutic or preventative options for other infectious diseases in the U.S. or globally and whether we have adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause our 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 our Annual Report on Form 10-K for the year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, each filed with the Securities and Exchange Commission (the “SEC”), and in our other filings with the SEC, and in Invivyd’s future reports to be filed with the SEC and available at www.sec.gov. Such risks may be amplified by the impacts of the COVID-19 pandemic. 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.This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts
Media Contact:
Tony Berry, Evoke Canale
774-317-0422
anthony.berry@evokegroup.comInvestor Contact:
Chris Brinzey, ICR Westwicke
339-970-2843
chris.brinzey@westwicke.com