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Invivyd to Present PEMGARDA™ (pemivibart) Data at Infectious Disease Week (IDWeek) 2024

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Invivyd (Nasdaq: IVVD) announced upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024 in Los Angeles, October 16-19, 2024. The presentations include:

  • An oral presentation on clinical efficacy endpoints from the Phase 3 CANOPY Study
  • A poster on results from a Phase 1 first-in-human study
  • A poster on pharmacokinetics and serum virus neutralizing antibody titers following the 2nd dose in the Phase 3 CANOPY Trial

Robert Allen, Chief Scientific Officer at Invivyd, emphasized the importance of sharing this data as COVID-19 continues to pose a threat, particularly to immunocompromised individuals. The company will make the posters and presentation available on their website after the conference.

Invivyd (Nasdaq: IVVD) ha annunciato le prossime presentazioni dei dati su pemivibart derivanti dai suoi studi clinici di Fase 1 e Fase 3 durante IDWeek 2024 a Los Angeles, dal 16 al 19 ottobre 2024. Le presentazioni includono:

  • Una presentazione orale sugli endpoint di efficacia clinica dello Studio CANOPY di Fase 3
  • Un poster sui risultati di uno studio di Fase 1 per la prima volta su esseri umani
  • Un poster sulla farmacocinetica e sui titoli anticorpali neutralizzanti del virus nel siero dopo la seconda dose nella Fase 3 dello Studio CANOPY

Robert Allen, Chief Scientific Officer di Invivyd, ha sottolineato l'importanza di condividere questi dati poiché il COVID-19 continua a rappresentare una minaccia, in particolare per le persone immunocompromesse. L'azienda renderà disponibili i poster e la presentazione sul proprio sito web dopo la conferenza.

Invivyd (Nasdaq: IVVD) anunció las próximas presentaciones de datos sobre pemivibart de los ensayos clínicos de Fase 1 y Fase 3 en IDWeek 2024 en Los Ángeles, del 16 al 19 de octubre de 2024. Las presentaciones incluyen:

  • Una presentación oral sobre los puntos finales de eficacia clínica del Estudio CANOPY de Fase 3
  • Un póster sobre los resultados de un estudio de Fase 1 en humanos por primera vez
  • Un póster sobre farmacocinética y niveles de anticuerpos neutralizantes del virus en suero tras la segunda dosis en el Ensayo CANOPY de Fase 3

Robert Allen, Director Científico de Invivyd, enfatizó la importancia de compartir estos datos dado que el COVID-19 continúa representando una amenaza, especialmente para las personas inmunocomprometidas. La empresa hará que los pósters y la presentación estén disponibles en su sitio web después de la conferencia.

Invivyd (Nasdaq: IVVD)는 pemivibart 데이터의 Fase 1 및 Fase 3 임상 시험 결과를 IDWeek 2024에서 발표할 예정이라고 발표했습니다. 이 행사는 2024년 10월 16일부터 19일까지 로스앤젤레스에서 개최됩니다. 발표 내용은 다음과 같습니다:

  • Fase 3 CANOPY 연구의 임상 효능 평가지표에 대한 구두 발표
  • 1상 사람 최초 연구 결과에 대한 포스터
  • Fase 3 CANOPY 시험의 두 번째 용량 후 약리학적 동태 및 혈청 내 바이러스 중화 항체 수준에 대한 포스터

Invivyd의 최고 과학 책임자 로버트 앨런은 COVID-19가 계속해서 위협을 주고 있으며 특히 면역이 약화된 개인에게 위험하므로 이러한 데이터를 공유하는 것이 중요하다고 강조했습니다. 회사는 회의 후 웹사이트에 포스터와 발표 자료를 제공할 것입니다.

Invivyd (Nasdaq: IVVD) a annoncé de prochaines présentations des données sur pemivibart issues de ses essais cliniques de Phase 1 et Phase 3 lors de IDWeek 2024 à Los Angeles, du 16 au 19 octobre 2024. Les présentations incluront :

  • Une présentation orale sur les critères d'efficacité clinique de l'étude CANOPY de Phase 3
  • Un poster sur les résultats d'une étude de Phase 1 chez l'homme
  • Un poster sur la pharmacocinétique et les titres d'anticorps neutralisants du virus dans le sérum après la deuxième dose dans l'essai CANOPY de Phase 3

Robert Allen, directeur scientifique d'Invivyd, a souligné l'importance de partager ces données alors que le COVID-19 continue de représenter une menace, en particulier pour les personnes immunodéprimées. L'entreprise mettra les posters et la présentation à disposition sur son site internet après la conférence.

Invivyd (Nasdaq: IVVD) kündigte an, dass kommende Präsentationen von pemivibart-Daten aus den klinischen Studien der Phase 1 und Phase 3 während der IDWeek 2024 in Los Angeles vom 16. bis 19. Oktober 2024 stattfinden werden. Die Präsentationen umfassen:

  • Eine mündliche Präsentation zu klinischen Wirksamkeitsendpunkten der Phase 3 CANOPY-Studie
  • Ein Poster zu Ergebnissen einer Phase 1-Studie mit ersten menschlichen Probanden
  • Ein Poster über Pharmakokinetik und Serum-neutralisierende Antikörpertitel nach der zweiten Dosis in der Phase 3 CANOPY-Studie

Robert Allen, Chief Scientific Officer von Invivyd, betonte die Bedeutung der Datenweitergabe, da COVID-19 weiterhin eine Bedrohung darstellt, insbesondere für immungeschwächte Personen. Das Unternehmen wird die Poster und Präsentationen nach der Konferenz auf seiner Website zur Verfügung stellen.

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WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024. The conference is being held in Los Angeles, October 16-19, 2024.

Invivyd will be presenting the following oral and poster presentations:

Title

Presenting AuthorPresentation
Timing
Oral Presentation: Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart ​

Anna Holmes, Ph.D., Principal Clinical ScientistOctober 17 (11:18-11:30am PT/2:18 -2:30pm ET)​
Poster: Results from a Phase 1 First in Human Study of Pemivibart: An Extended Half-Life Monoclonal Antibody (mAb)

Amanda Copans, PharmD, Vice President, Medical Affairs

October 19 (12:15 – 1:30pm PT/3:15 – 4:30pm ET)
Poster: Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY Trial

Pamela Hawn, PharmD, Senior Director of Medical AffairsOctober 19 (12:15 – 1:30pm PT/3:15 – 4:30pm ET)


“We are excited to share these data with the infectious disease community as the threat from COVID-19 persists and has a disproportionate impact on individuals with compromised immune systems who may not be fully protected by vaccines,” said Robert Allen, Ph.D., Chief Scientific Officer at Invivyd.

A copy of the posters and presentation will be available on the company’s website following the conference.

About PEMGARDA

PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.

PEMGARDA injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.  Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination.  In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.

Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.

To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.  PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. 

About Invivyd  
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://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,” “estimates,” “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 company’s ongoing research and clinical development activities, as well as future potential research and clinical development efforts; the COVID-19 landscape and potential impact on individuals with compromised immune systems who may not be fully protected by vaccines; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the company’s INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; 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, progress and results of the company’s discovery, preclinical and clinical development activities; the risk that results of nonclinical 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 nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; 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 pemivibart 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; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revised or revoked by the FDA; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company’s product candidates; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; changes in the regulatory environment; changes in expected or existing competition; the complexities of manufacturing mAb therapies; the company’s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; any legal proceedings or investigations relating to the company; 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, 2023 and the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, each 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.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Contacts:  
Media Relations  
(781) 208-0160  
media@invivyd.com 

Investor Relations  
(781) 208-0160  
investors@invivyd.com


FAQ

What data is Invivyd presenting at IDWeek 2024?

Invivyd is presenting pemivibart data from its Phase 1 and Phase 3 clinical trials, including clinical efficacy endpoints from the CANOPY Study, results from a first-in-human study, and pharmacokinetics and antibody titers following the second dose in the CANOPY Trial.

When and where is IDWeek 2024 taking place?

IDWeek 2024 is being held in Los Angeles from October 16-19, 2024.

What is the stock symbol for Invivyd?

Invivyd's stock symbol is IVVD, traded on the Nasdaq.

Who will be presenting Invivyd's data at IDWeek 2024?

The presenters include Anna Holmes, Ph.D., Principal Clinical Scientist; Amanda Copans, PharmD, Vice President of Medical Affairs; and Pamela Hawn, PharmD, Senior Director of Medical Affairs.

What is pemivibart?

Pemivibart is an extended half-life monoclonal antibody (mAb) developed by Invivyd for protection against COVID-19, particularly for immunocompromised individuals who may not be fully protected by vaccines.

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