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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 (Nasdaq: IVVD) has announced its participation in the upcoming Guggenheim Securities Healthcare Innovation Conference in Boston, MA. The company's management will engage in a fireside chat scheduled for Wednesday, November 13, 2024, at 2:30 PM ET, along with conducting one-on-one investor meetings during the conference, which runs from November 11-13, 2024.
A live webcast of the presentation will be accessible through the investor section of Invivyd's website and will remain available for approximately 30 days after the event.
Invivyd (Nasdaq: IVVD) has scheduled a conference call for November 14, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results and provide business updates. The company, which focuses on protection from serious viral infectious diseases, previously released preliminary Q3 2024 results on October 29, 2024. The webcast will include a Q&A session for analysts, who are advised to join 15 minutes early. A replay will be available on the company's investor relations website approximately two hours after the call ends.
Invivyd reported preliminary Q3 2024 results, with PEMGARDA™ net product revenue of $9.3 million and approximately $107 million in cash and equivalents. The company withdrew its previous guidance of $150-200 million in PEMGARDA revenue for 2024 due to growth headwinds from an FDA warning regarding reduced activity of pemivibart. The warning was based on contested, third-party data from a non-pemivibart antibody. Despite these challenges, Invivyd expects to finish 2024 with $65 million or more in cash and targets profitability in 1H 2025 through anticipated revenue growth and operational efficiencies.
Invivyd announced positive 12-month exploratory clinical efficacy data from their CANOPY Phase 3 trial of PEMGARDA™ (pemivibart) for COVID-19 pre-exposure prophylaxis. The data showed 76% overall protection over 12 months following two initial doses, with 84% relative risk reduction in the first 6 months and 64% protection during months 7-12 without additional doses. The trial included immunocompetent participants during the U.S. summer KP.3 and KP.3.1.1 dominant wave. The safety profile remained consistent with no new safety signals, though some participants experienced mild to moderate infusion-related reactions and rare cases of anaphylaxis were reported in Cohort A.
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) announced that the FDA has updated the Emergency Use Authorization (EUA) Fact Sheet for PEMGARDA™ (pemivibart) with accurate SARS-CoV-2 variant susceptibility data. The updated Fact Sheet, dated September 26, 2024, includes in vitro neutralization activity against dominant circulating variants, including KP.3.1.1 and LB.1, which is in line with prior variants represented in the CANOPY Phase 3 clinical trial.
The FDA removed a contested statement about reduced susceptibility to pemivibart for KP.3.1.1, based on data provided by LabCorp's Monogram Biosciences lab. Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart under industrial-quality conditions for assessing neutralization potency and variant susceptibility.
Invivyd, Inc. (Nasdaq: IVVD) has provided detailed virology data and analysis of SARS-CoV-2 structural biology, predicting anticipated neutralization activity for PEMGARDA™ (pemivibart). Key points include:
- Independent evaluation shows in vitro pseudovirus neutralization potency of PEMGARDA against KP.3.1.1 and LB.1 variants in-line with prior variants tested
- Ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site
- Potential emerging variants (XEC and LP.1) encode mutations distal from the pemivibart binding site, not expected to meaningfully alter activity
- Pemivibart potency against contemporary viruses remains in-line with predominant variants since 2022
- Structural analysis shows no meaningful mutational change in the pemivibart binding site since late 2021
The company's ongoing genetic and structural analyses provide the biological rationale for expected neutralization activity of pemivibart against evolving SARS-CoV-2 variants.
Invivyd, Inc. (Nasdaq: IVVD) announces readiness to address the increasing COVID-19 cases with PEMGARDA™ (pemivibart), an FDA-authorized monoclonal antibody for pre-exposure prophylaxis in certain immunocompromised individuals. The CDC reports a continued rise in COVID-19 death rates throughout 2024, with immunocompromised patients at highest risk. PEMGARDA is covered by Medicare and Medicaid and has gained rapid commercial coverage across major health plans.
The Infectious Disease Society of America recommends PEMGARDA for PrEP in moderately to severely immunocompromised adults and adolescents at risk of severe COVID-19. Invivyd has launched a Patient Savings Program to assist eligible commercially insured patients. Recent data shows PEMGARDA's continued neutralizing activity against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1. Invivyd is also developing VYD2311, a next-generation mAb candidate with promising early results.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company focused on protection from serious viral infectious diseases, has announced its participation in three upcoming investor conferences in New York, NY:
- Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024, at 10:00 AM ET
- H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 9:30 AM ET
- 2024 Cantor Global Healthcare Conference on September 18, 2024, at 10:55 AM ET
Live webcasts of the fireside chats will be available on Invivyd's investor website and archived for approximately 90 days after the events.
Invivyd (Nasdaq: IVVD) has initiated dosing in the Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody for COVID-19. This trial, conducted in Australia, will assess safety, tolerability, pharmacokinetics, and immunogenicity in healthy volunteers. VYD2311 has shown high in vitro neutralization potency against post-Omicron variants and will explore intramuscular administration for improved patient convenience.
The company expects preliminary data in Q4 2024, with additional clinical readouts throughout 2025. VYD2311 aims to build on the success of PEMGARDA™ (pemivibart), which recently received FDA Emergency Use Authorization for pre-exposure prophylaxis in certain immunocompromised patients.
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