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Scientist Dr. Akiko Iwasaki Joins SPEAR Study Group to Investigate Monoclonal Antibodies for Long COVID and COVID-19 Post-Vaccination Syndrome
Globenewswire· 2025-07-23 11:01
WALTHAM, Mass., July 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced the addition of Akiko Iwasaki, Ph.D., Professor of Immunobiology at Yale School of Medicine, to the SPEAR (Spike Protein Elimination and Recovery) Study Group. The SPEAR Study Group was launched earlier this month to focus on the biology and clinical disease or injury associated with persistent presence of spike antigen from SARS-CoV-2 virus or COVID-19 vaccines. Dr. Iwasaki is internationally recognized for her ...
National Comprehensive Cancer Network® (NCCN®) Guidelines Recommend Monoclonal Antibodies for COVID-19 Prevention in People with Cancer; New Data Published in JAMA Oncology Underscore Severe Impact of COVID-19 on This Population
Globenewswire· 2025-07-21 11:05
NCCN Clinical Practice Guidelines in Oncology for the Prevention and Treatment of Cancer-Related Infections now recommend monoclonal antibodies for pre-exposure prophylaxis against COVID-19 in appropriate cancer populationsReflects growing alignment among NCCN, IDSA, and CDC on the role of monoclonal antibodies in protecting immunocompromised individuals from COVID-19New data published online in JAMA Oncology from the National Cancer Institute COVID-19 in Cancer Patients Study showed COVID-19 had a signific ...
Invivyd and Leading Researchers Form SPEAR (Spike Protein Elimination and Recovery) Study Group to Assess the Effects of Monoclonal Antibody Therapy for Long COVID and COVID-19 Post-Vaccination Syndrome
Globenewswire· 2025-07-02 11:01
Core Insights - Invivyd, Inc. has established the SPEAR Study Group to investigate the effects of monoclonal antibody therapy on Long COVID and Post-Vaccination Syndrome, focusing on the role of persistent SARS-CoV-2 spike protein [1][2][4] Group 1: SPEAR Study Group Formation - The SPEAR Study Group aims to conduct clinical trials evaluating broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibody therapy for patients suffering from Long COVID and PVS [1][2] - The initiative was prompted by increasing anecdotal evidence suggesting symptom relief in Long COVID patients following treatment with PEMGARDA (pemivibart), a monoclonal antibody authorized for COVID-19 prevention in immunocompromised individuals [2][5] - The group includes leading researchers in the field, such as Dr. Michael Peluso, Dr. Amy Proal, and Dr. David Putrino, who will collaborate on the design and execution of clinical trials [3][6] Group 2: Clinical Research and Objectives - The SPEAR Study Group plans to initiate multi-center translational clinical research on Long COVID and PVS, utilizing next-generation monoclonal antibody candidates like VYD2311 [3][5] - Initial efforts will focus on rigorous assessments of monoclonal antibody safety, translational biology, and exploratory efficacy in patients with persistent viral reservoirs or circulating spike protein [5][7] - The research aims to explore the underlying biology of Long COVID and establish efficacy endpoints that could support future registrational studies [2][4] Group 3: Monoclonal Antibody Overview - PEMGARDA is a half-life extended investigational monoclonal antibody that has shown in vitro neutralizing activity against major SARS-CoV-2 variants [8][9] - The antibody targets the spike protein receptor binding domain, inhibiting virus attachment to human cells [8] - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new COVID-19 prophylactic and therapeutic options, leveraging Invivyd's proprietary technology platform [15][16]
Invivyd Announces Positive Full Phase 1/2 Clinical Data for VYD2311, a Next Generation COVID-19 Monoclonal Antibody for Potential Use as a Non-Vaccine Preventative and for Treatment of Active Infection
Globenewswire· 2025-06-26 11:01
Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]
Invivyd Announces Publication of Landmark CANOPY Phase 3 PEMGARDA® (pemivibart) Clinical Trial; Results Underscore Strong Efficacy of Monoclonal Antibodies in Preventing COVID-19 in a Modern U.S. Population Against Relevant, Immune-Evasive SARS-CoV-2 Virus
GlobeNewswire· 2025-05-27 11:01
Core Insights - Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial of pemivibart, demonstrating its safety and efficacy for the prevention of symptomatic COVID-19 in a contemporary U.S. population facing immune-evasive Omicron variants [1][4][6] Group 1: Clinical Trial Overview - The CANOPY Phase 3 clinical trial randomized 788 adult participants across 18 sites, focusing on immunocompromised individuals and those at risk due to regular face-to-face interactions [2][8] - The trial met all primary and exploratory endpoints during a significant COVID-19 transmission period in the U.S. from September 2023 to September 2024 [2][8] - Pemivibart showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months [4][6] Group 2: Safety and Tolerability - Pemivibart was generally well-tolerated, with most adverse events classified as mild to moderate [3][6] - The most common treatment-emergent adverse events included infusion-related reactions, with a low incidence of anaphylactic reactions (0.6%) [3][12] - The safety profile aligns with previous clinical trials for COVID-19 monoclonal antibodies [3][6] Group 3: Regulatory and Future Implications - The trial's results support the emergency use authorization (EUA) of PEMGARDA (pemivibart) for pre-exposure prophylaxis in certain immunocompromised patients [2][10] - The publication aims to educate clinicians on the potential of monoclonal antibodies in combating COVID-19, particularly for immunocompromised individuals [5][7] - Invivyd plans to leverage data from the CANOPY trial to expedite the approval of novel antibodies like VYD2311 [7][18]
Invivyd Announces Inclusion of PEMGARDA® (pemivibart) in National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas
Globenewswire· 2025-05-23 11:01
Core Insights - Invivyd, Inc. announced that its investigational monoclonal antibody PEMGARDA (pemivibart) has been included in the NCCN Clinical Practice Guidelines for B-Cell Lymphomas, recognizing its potential for pre-exposure prophylaxis against COVID-19 in immunocompromised patients [1][2][3] Group 1: Product Development and Approval - PEMGARDA is recognized as a potential option for pre-exposure prophylaxis against COVID-19 in patients with B-cell malignancies, particularly those who may not respond adequately to vaccination [2][3] - The monoclonal antibody is engineered to retain activity against circulating SARS-CoV-2 variants and is currently authorized under Emergency Use Authorization (EUA) from the U.S. FDA for certain patients [3][6] - The NCCN's recommendation is based on the unmet need in patients with B-cell lymphomas, who are at elevated risk for COVID-19-related complications [3][4] Group 2: Clinical Implications - The inclusion of PEMGARDA in the NCCN Guidelines provides clinicians with a valuable tool to protect vulnerable patients from COVID-19, allowing them to continue their cancer care [3][4] - The updated NCCN Guidelines reflect growing clinical and real-world evidence supporting the use of passive immunization to complement vaccination strategies in high-risk oncology populations [4] Group 3: Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, starting with SARS-CoV-2 [13] - The company utilizes a proprietary integrated technology platform designed to assess, monitor, develop, and adapt to create best-in-class antibodies [13]
Invivyd Commends FDA Focus on Contemporary Evidence In Evaluating Medical Interventions To Prevent COVID-19
Globenewswire· 2025-05-21 13:30
Core Insights - Invivyd, Inc. commends the FDA for addressing uncertainties regarding COVID-19 vaccine booster efficacy and providing a pathway to resolve these issues [1][4] - The FDA has encouraged manufacturers to conduct randomized, placebo-controlled trials to evaluate the efficacy of COVID-19 vaccines, particularly in individuals who have had COVID-19 within the past year [2][4] - Invivyd's CANOPY Phase 3 clinical trial of pemivibart demonstrated an 84% reduction in the risk of symptomatic COVID-19 compared to placebo, highlighting the potential of monoclonal antibodies as a viable alternative to vaccines [2][3][4] FDA's Actions and Recommendations - The FDA has identified gaps in the understanding of COVID-19 vaccine booster efficacy and has called for trials to include healthy adults and those who have had COVID-19 recently [2][4] - The FDA considers a 30% reduction in symptomatic COVID-19 as "meaningful" protection, while Invivyd's pemivibart showed an 84% reduction, suggesting a significantly higher level of efficacy [3][4] Invivyd's Clinical Trials and Products - The CANOPY Phase 3 trial included a randomized cohort of individuals at risk of acquiring SARS-CoV-2, with a follow-up period of six months to assess the durability of the vaccine's efficacy [2][14] - Invivyd plans to advance next-generation monoclonal antibodies to improve scalability and efficacy, with an update on investigational mAb VYD2311 expected soon [4][6][15] Monoclonal Antibodies as a Treatment Option - The FDA has acknowledged the uncertainty surrounding the benefits of repeat COVID-19 vaccine boosters, positioning monoclonal antibody therapies like pemivibart as a critical alternative [4][5] - Invivyd emphasizes the importance of monoclonal antibodies for high-risk populations, particularly children, due to the limitations of vaccination strategies [5][6] Future Developments - Invivyd is set to engage with the FDA on expedited pathways for developing scalable COVID-19 prevention and treatment options, addressing the ongoing health crisis posed by COVID-19 [4][6][17] - The company is focused on delivering high-quality protection against COVID-19, with a commitment to advancing innovative antibody candidates [17]
Adagio(IVVD) - 2025 FY - Earnings Call Transcript
2025-05-20 16:00
Invivyd (IVVD) FY 2025 Conference May 20, 2025 11:00 AM ET Speaker0 Not ready. Okay. Hello, everyone, and welcome to the third annual, HC Wainwright BioConnect Conference. I'm Patrick Trucchio, a senior health parent at HC Wainwright. It's my pleasure to, introduce you to the management of InVivid. I'm Katie Falzoni, senior vice president of finance and Robert Allen, CSO. So first, I think it'd be good to start out with, some background on Invivid platform and on the validation of this antibody platform. Sp ...
Adagio(IVVD) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:32
Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Katie Falzone - SVP - FinanceMarc Elia - Chairperson of the BoardTimothy Lee - Chief Commercial OfficerRobert Allen - Chief Scientific OfficerMark Wingertzahn - Senior Vice President of Clinical Development & Medical AffairsWilliam Duke - Chief Financial OfficerKyle Yang - Senior AssociateLuis Santos - Senior Equity Research Associate, Healthcare & Biotechnology Operator Thank you for standing by, and welcome to Nvivit's Firs ...
Adagio(IVVD) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:30
Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Speaker0 Thank you for standing by, and welcome to Nvivit's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again. I would now like to hand the call over to Katie Bozzon ...