Invivyd begins Phase 1 trial for new COVID-19 antibody

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ: IVVD), a biopharmaceutical company, has initiated a Phase 1 clinical trial for its monoclonal antibody (mAb) candidate, VYD2311, aimed at combating COVID-19. The trial, which started dosing healthy volunteers this week, is set to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311, with a focus on its efficacy against post-Omicron variants.

The randomized, placebo-controlled study is being conducted in Australia, examining multiple dose levels and routes of administration, including intramuscular injections, which could offer a more patient-friendly alternative to intravenous methods. VYD2311 was designed through affinity maturation to target recent SARS-CoV-2 variants effectively.

Preliminary data from the Phase 1 trial are expected to be released in the fourth quarter of 2024, with further clinical outcomes anticipated throughout 2025. This development follows the Emergency Use Authorization granted by the U.S. Food and Drug Administration for PEMGARDA™ (pemivibart), another mAb by Invivyd, for pre-exposure prophylaxis in immunocompromised individuals.

Marc Elia, Chairman of the Board at Invivyd, expressed optimism about VYD2311's potential to build upon PEMGARDA's success. He highlighted the continued global threat posed by COVID-19 and the company's commitment to advancing treatments in step with the virus's evolution.

VYD2311 is engineered from adintrevimab, an investigational mAb with a robust safety profile and clinical efficacy demonstrated in global Phase 3 trials for both prevention and treatment of COVID-19. Its pharmacokinetic profile may allow for clinically meaningful titer levels through more accessible administration methods.

PEMGARDA, derived from adintrevimab as well, has shown in vitro neutralizing activity against major SARS-CoV-2 variants and targets the virus's spike protein receptor binding domain. The EUA for PEMGARDA is based on an immunobridging approach and its effectiveness against SARS-CoV-2 variants is subject to ongoing evaluation.

Invivyd's proprietary INVYMAB™ platform combines viral surveillance and predictive modeling with advanced antibody engineering to rapidly generate new mAbs to address evolving viral threats. The company's focus remains on providing protection from serious viral infectious diseases, starting with SARS-CoV-2.

This report is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. Invivyd has cautioned that these statements are not guarantees of future performance and actual results may differ materially.

In other recent news, Invivyd, Inc., a biopharmaceutical company, has reported promising results from its Phase 3 trial of PEMGARDA, a monoclonal antibody for COVID-19 prevention. The company's investigational antibody has shown to retain neutralizing activity against a range of SARS-CoV-2 variants, including the rising KP.3.1.1 strain. The trial revealed an 84% reduction in symptomatic COVID-19 risk, a development that has been well received by investors and analysts alike. H.C. Wainwright maintained a Buy rating on Invivyd, reflecting confidence in the company's performance.

Invivyd's second-quarter financials showed revenues reaching $2.3 million, falling short of the anticipated $6.9 million. However, the company expects revenue growth in the second half of the year. Invivyd is also advancing another monoclonal antibody candidate, VYD2311, and expanding access to PEMGARDA for immunocompromised individuals. On the corporate front, Invivyd appointed Timothy Lee as Chief Commercial Officer, a move expected to enhance the company's commercial strategy.

These are recent developments in Invivyd's ongoing efforts to combat respiratory viruses. The company has also submitted an EUA amendment request to the FDA for PEMGARDA's use in treating mild-to-moderate COVID-19 in certain immunocompromised patients. Despite facing supply constraints that affect its ability to expand in international markets, Invivyd remains optimistic about future results and the upcoming respiratory virus season.

InvestingPro Insights

As Invivyd, Inc. (NASDAQ: IVVD) forges ahead with its Phase 1 clinical trial for VYD2311, the company's financial health and market performance provide a backdrop for investors monitoring the biopharmaceutical landscape. With a market capitalization of $101.74 million, Invivyd sits in a unique position, holding more cash than debt on its balance sheet, which is a reassuring sign for stakeholders considering the company's financial stability.

However, an InvestingPro Tip highlights that Invivyd is quickly burning through cash, a situation that could raise concerns about the company's long-term funding strategy, especially as it continues to invest heavily in research and development for its COVID-19 treatments. Additionally, analysts are not expecting Invivyd to turn a profit this year, which is a critical consideration for investors looking for growth in their portfolios.

From a market perspective, Invivyd's stock has experienced significant volatility, trading near its 52-week low and reflecting a substantial price drop over the last six months. This performance is in line with the company's -78.54% 6-month price total return. Despite these challenges, Invivyd's gross profit margin remains impressively high at 96.11% for the last twelve months as of Q2 2024, indicating effective cost management relative to its revenue.

For investors seeking a more comprehensive analysis, there are additional InvestingPro Tips available on https://www.investing.com/pro/IVVD. These insights can provide deeper context into Invivyd's financials, market performance, and future prospects, helping to inform investment decisions in the biopharmaceutical sector.

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