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About Invivyd, Inc. (Nasdaq: IVVD)
Invivyd, Inc. is a clinical-stage biopharmaceutical company dedicated to delivering innovative solutions to combat serious viral infectious diseases, starting with SARS-CoV-2. Leveraging its proprietary INVYMAB™ platform, the company integrates state-of-the-art viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate monoclonal antibodies (mAbs) that address evolving viral threats. This approach allows Invivyd to design and adapt antibodies with enhanced potency, durability, and broader coverage against viral variants.
Core Business and Products
Invivyd's flagship product, PEMGARDA™ (pemivibart), is a half-life extended investigational monoclonal antibody authorized by the U.S. Food and Drug Administration (FDA) for emergency use in the pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients. Engineered from the investigational mAb adintrevimab, PEMGARDA has demonstrated neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, and XEC, by targeting the spike protein receptor binding domain (RBD) to inhibit viral attachment to human cells.
The company is also advancing VYD2311, a next-generation mAb designed for superior potency and broader coverage. VYD2311 offers the potential for more patient-friendly administration routes, including intramuscular (IM) and subcutaneous (SC) injections, and aims to serve as both a prophylactic and therapeutic option for COVID-19. With a pharmacokinetic profile supporting long-lasting protection, VYD2311 is positioned as a scalable alternative to traditional vaccines and therapies.
Technological Edge
Invivyd's competitive advantage lies in its INVYMAB™ platform, which enables the rapid, serial development of mAbs optimized for evolving viral landscapes. By employing predictive modeling and directed molecular evolution, the platform ensures that antibodies maintain efficacy against contemporary and future variants. This capability positions Invivyd as a leader in the development of evolution-resistant and durable mAbs for pandemic preparedness.
Market Significance and Unmet Needs
Invivyd addresses critical gaps in protection for vulnerable populations, particularly immunocompromised individuals who may not respond adequately to vaccines. With millions of such individuals in the U.S. alone, the company's products provide a vital option for pre-exposure prophylaxis and treatment. The ongoing development of VYD2311 further expands Invivyd's potential to serve broader populations, including those seeking long-term protection and convenient administration.
Challenges and Opportunities
While Invivyd faces challenges such as regulatory scrutiny, manufacturing complexities, and competition from other biopharmaceutical companies, its focus on innovation and adaptability sets it apart. The company's commitment to addressing unmet medical needs through advanced antibody engineering positions it as a key player in the fight against viral infectious diseases.
Conclusion
Invivyd, Inc. exemplifies a forward-thinking approach to biopharmaceutical innovation, combining cutting-edge technology with a mission to protect vulnerable populations from serious viral threats. Through its robust pipeline and strategic focus on long-acting, evolution-resistant antibodies, Invivyd is poised to make a significant impact on global health.
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company, announced that CEO David Hering will present at H.C. Wainwright's BioConnect Investor Conference on May 2, 2023, at 4:00 p.m. ET, held at Nasdaq World Headquarters in New York. The presentation aims to discuss Invivyd's mission of delivering antibody-based therapies to protect vulnerable populations from viral infectious diseases, particularly SARS-CoV-2. A live webcast of the presentation will be accessible on the company's investor website and archived for 90 days post-event.
Invivyd is focused on developing a pipeline of high-quality, long-lasting antibodies to combat serious viral threats, starting with COVID-19 and extending to influenza and other significant diseases. For more information, visit invivyd.com.
Invivyd, Inc. (Nasdaq: IVVD) announced the FDA's clearance of its IND application for VYD222, a monoclonal antibody candidate aimed at preventing COVID-19 in vulnerable populations. The ongoing Phase 1 trial in Australia has completed dosing of the first cohort, moving to the second cohort, with initial readouts expected in Q2 2023. This trial is designed to evaluate safety, tolerability, and neutralizing activity against emerging variants. VYD222 is targeted at immunocompromised individuals who may not respond adequately to COVID-19 vaccines. The drug has shown in vitro neutralizing activity against the XBB.1.5 variant. Regulatory discussions are also underway for the pivotal trial design.
Invivyd, Inc. (Nasdaq: IVVD) announced the appointment of Robert Allen as chief scientific officer and Stacy Price as chief technology and manufacturing officer. Dr. Allen, with over 30 years of experience in infectious diseases, will lead the company's scientific direction and help develop therapies across Invivyd's pipeline, particularly focusing on antibodies for COVID-19 variants. Stacy Price, who joined Invivyd in March 2023, brings extensive biotechnology operations experience and will enhance the company's chemistry, manufacturing, and controls programs. Invivyd aims to deliver antibody-based therapies to protect vulnerable populations from serious viral diseases, including COVID-19 and influenza. CEO David Hering emphasized the strategic importance of these appointments for strengthening Invivyd's capabilities and advancing its product candidates.
Invivyd, Inc. (Nasdaq: IVVD) announced the initiation of a Phase 1 clinical trial for its monoclonal antibody candidate, VYD222, aimed at addressing COVID-19 in vulnerable populations. This randomized, placebo-controlled trial, featuring three IV infusion doses, will assess safety and pharmacokinetics. Preliminary data is expected in Q2 2023, with further clinical insights anticipated throughout the year. The trial is crucial as current authorized treatments show reduced efficacy against emerging SARS-CoV-2 variants. VYD222 has demonstrated in vitro activity against variants like XBB.1.5, providing hope for immunocompromised individuals who may not respond adequately to vaccination.
Invivyd, Inc. (Nasdaq: IVVD) announced it is advancing VYD222 into clinical development, demonstrating neutralizing activity against key COVID-19 variants. In 2022, the company reported a net loss of $241.3 million and expects its cash reserves of $372 million to support operations into the second half of 2024. The focus on VYD222 aims to fulfill the urgent need for effective therapies for vulnerable populations. This follows a strategic pivot to monoclonal antibody candidates as regulatory landscapes evolve. A conference call scheduled for March 23, 2023, will further detail these developments.
Invivyd, Inc. (Nasdaq: IVVD) announces the publication of research in Science Translational Medicine, detailing a model for evaluating monoclonal antibody (mAb) efficacy against symptomatic COVID-19. The Phase 2/3 study of adintrevimab indicates that low neutralizing antibody titers can provide clinically meaningful protection. This work is expected to influence regulatory frameworks for mAbs, potentially expediting development processes. The study identifies a protective titer threshold of 1:30, with higher levels enhancing protection. Invivyd plans to advance its candidate VYD222 into clinical trials soon, aiming to address evolving variants.
Invivyd, Inc. (Nasdaq: IVVD) announced a conference call scheduled for March 23, 2023, at 4:30 p.m. ET. The call will discuss its financial results for the year ended December 31, 2022, alongside recent business highlights. Invivyd is focused on developing antibody-based therapies targeting serious viral threats, notably SARS-CoV-2. The company employs advanced techniques in evolutionary virology and antibody engineering to create long-lasting antibodies to counteract viral escape. Investors and analysts can register for the call and access a replay via the company's investor website.
Invivyd, Inc. (Nasdaq: IVVD) announced the election of its monoclonal antibody candidate VYD222 for clinical advancement as a therapeutic option for COVID-19, particularly targeting immunocompromised individuals. The company aims to leverage emerging global regulatory frameworks to expedite development. Currently, no monoclonal antibodies are authorized in the U.S. for COVID-19 prevention or treatment. VYD222, engineered from the investigational adintrevimab, has shown in vitro neutralizing activity against dominant variants, including XBB.1.5. A Phase 1 clinical trial is planned for Q1 2023.
On February 28, 2023, Invivyd, a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker IVVD, announced that CEO David Hering will present at Cowen's 43rd Annual Healthcare Conference on March 6, 2023, at 2:10 p.m. ET. The presentation will be available as a live webcast and archived for 90 days on the company’s investor website. Invivyd focuses on combating viral respiratory diseases through innovative antibody development, particularly targeting COVID-19. The company aims to enhance natural immunity to provide superior viral protection.
Invivyd, Inc. (Nasdaq: IVVD) announced the departure of its Chief Scientific Officer, Laura Walker, Ph.D., who is leaving to pursue other opportunities. Lukas Dillinger, Ph.D., has been appointed interim Head of Discovery and Pre-Clinical during the search for a replacement. CEO David Hering expressed gratitude for Walker's contributions, which were essential in establishing the company's pipeline of antibody candidates against SARS-CoV-2. Invivyd focuses on developing antibodies for serious infectious diseases, particularly COVID-19, with ongoing efforts to advance its pipeline of antibody therapies.
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