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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) participated in an FDA-EMA workshop on December 15, 2022, focusing on SARS-CoV-2 monoclonal antibodies. The company's chief scientific officer, Laura Walker, Ph.D., presented alongside industry leaders to discuss strategies for accelerating antibody development amid evolving variants. The presentation underscored the unmet medical need for COVID-19 therapies and proposed data-driven policy changes to optimize development timelines. Invivyd's antibody technologies aim to provide superior protection against viral diseases, including COVID-19.
Invivyd, Inc. (Nasdaq: IVVD) has announced key management changes effective December 16, 2022. Jeremy Gowler has been appointed as the Chief Operating and Commercial Officer, bringing 20 years of biopharma experience, including leadership at Sandoz. Additionally, Pete Schmidt, previously Vice President of Clinical Research, has been promoted to Chief Medical Officer. The company aims to advance its monoclonal antibodies pipeline for COVID-19 and other respiratory diseases while streamlining operations following Dr. Ellie Hershberger's departure, who will provide consulting services.
Invivyd, a clinical-stage biopharmaceutical company (Nasdaq: IVVD), has announced a strategic partnership with Population Health Partners (PHP) aimed at improving the efficiency of its NVD200 clinical program and developing engineered antibodies for COVID-19. This collaboration will leverage PHP's expertise in clinical development and regulatory strategies, aligning Invivyd's capabilities with the evolving SARS-CoV-2 landscape.
Invivyd's NVD200 candidate, integrating adintrevimab, is set to enter clinical trials in Q1 2023, addressing the urgent need for effective treatments amid dwindling antibody effectiveness against emerging variants.
Invivyd (Nasdaq: IVVD) announced its third-quarter 2022 results, highlighting a cash position of $419 million, expected to fund operations into Q2 2024. The company aims to advance its monoclonal antibody candidate, NVD200, into clinical trials in Q1 2023. During the quarter, R&D expenses decreased to $34.1 million from $49.4 million in 2021, while SG&A expenses rose to $13.2 million. The net loss narrowed to $45.1 million from $60.4 million year-over-year, with a per-share loss of $0.42. A conference call is scheduled for November 10 at 4:30 p.m. ET.
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical firm, announced that CEO David Hering will participate in a fireside chat at the Jefferies London Healthcare Conference on November 15, 2022, at 4:25 p.m. GMT. The event will be accessible via a live webcast on the investor section of Invivyd’s website, with an archive available for 90 days post-presentation.
Invivyd focuses on developing antibodies to enhance immunity against serious viral respiratory diseases, including COVID-19. Its first candidate, NVD200, aims to prevent and treat COVID-19 using advanced antibody technology.
Invivyd, a clinical-stage biopharmaceutical company, announced a conference call to discuss its Q3 financial results on November 10, 2022, at 4:30 p.m. ET. The earnings report will cover the period ending September 30, 2022, alongside recent business highlights. Invivyd focuses on developing antibodies to combat viral respiratory diseases, notably COVID-19, with its candidate NVD200 showing promise. The company aims to enhance immunity against evolving viral threats. Analysts can join the Q&A session after the call.
Invivyd, Inc. (Nasdaq: IVVD) has appointed Christine Lindenboom, former senior vice president at Alnylam Pharmaceuticals, to its board of directors. Her extensive experience in healthcare and biopharmaceuticals is expected to enhance the company's strategic direction. Meanwhile, Redonda Miller, president of The Johns Hopkins Hospital, has stepped down from the board. Invivyd is focused on developing antibody solutions for viral diseases including COVID-19, with their first product, NVD200, anticipated to enter clinical trials in Q1 2023.
Invivyd (Nasdaq: IVVD) announced the appointment of Fred Driscoll as interim CFO, as part of a strategic restructuring to enhance capital efficiency and focus on key programs. The company is reallocating resources to support its integrated discovery platform and advance pipeline programs, particularly NVD200 for COVID-19 prevention and treatment. This transition follows the departure of Jane Pritchett Henderson and Eric Kimble, who are leaving to pursue other opportunities. An executive search for a permanent CFO and a business development executive is underway.
Invivyd (Nasdaq: IVVD) announced four poster presentations at ID Week 2022, showcasing findings from studies on adintrevimab. Key posters include:
- Poster 226: Higher Doses of Adintrevimab for COVID-19 treatment - Phase 1 preliminary results.
- Poster 591: Population Pharmacokinetics of Adintrevimab in clinical study participants.
- Poster 1113: Clinical outcomes with Early Adintrevimab Therapy in COVID-19.
- Poster 1132: Characterizing Viral Dynamics after Adintrevimab administration.
Adintrevimab remains investigational, showing promise against COVID-19 variants.
Invivyd, formerly Adagio Therapeutics, has generated multiple candidate antibodies for COVID-19 prevention and treatment. Their integrated discovery platform has produced NVD200, a novel combination of two monoclonal antibodies, set to enter clinical trials in Q1 2023. These antibodies show broad in vitro neutralization against a range of SARS-CoV-2 variants, including Omicron sublineages and SARS-CoV-1. Invivyd aims to provide enhanced protection from serious viral diseases through innovative antibody engineering, targeting non-overlapping epitopes to reduce immune pressure.
FAQ
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