(MENAFN- Investor Ideas) Investorideas ( ), a go-to platform for big investing ideas for stock traders, including biotech Stocks reports on trading and news for Invivyd, Inc. (Nasdaq: IVVD ) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases.
The stock is trading at 1.0150, up 0.6573, gaining 183.7573% on volume of over 422 Million shares, with a day's high of $1.11. The stock announced breaking news on its Monoclonal Antibody designed to be a superior alternative to COVID-19 Vaccination for the broad population
Invivyd, today announced positive data from its ongoing Phase 1/2 clinical trial of VYD2311, Invivyd's novel monoclonal antibody (mAb) candidate designed to be a superior alternative to COVID-19 vaccination for the broad population as frontline protection in a convenient form, as well as to provide a novel, potent, long-acting option for the treatment of COVID-19.
COVID-19 in 2024 caused approximately 59,0001 deaths, 665,0001 hospitalizations, and growing burden of Long COVID over time, despite broadly available and utilized vaccine boosts and small molecule therapy. The initial Phase 1/2 data support VYD2311's potential as a more effective and convenient option to manage this deadly disease.
Invivyd's ongoing randomized, double-blind, Phase 1/2 clinical trial is evaluating the safety and clinical pharmacokinetic (PK) profile of VYD2311 in 40 subjects across multiple routes of administration and dose levels for a single dose, and includes VYD2311 dosed intravenously (IV), intramuscularly (IM), and subcutaneously (SC) in four cohorts of 10 patients each, randomized 8:2 to receive drug or placebo. The Phase 1/2 clinical trial has fully enrolled, and all planned doses have been administered, with only long-term follow-up remaining.
While the Phase 1/2 trial remains blinded, all pooled, blinded adverse events (AEs) identified to date across all arms remain mild to moderate and largely confined to typical injection site reactions or infusion reactions.
A formal estimate of in vivo half-life is not yet available for VYD2311 given the long apparent half-life thus far. As of Day 65, serum concentrations remain high and represent a potential substantial increase in observed half-life of VYD2311 relative to pemivibart. Analysis for the IM cohort (the most advanced cohort in time) is tracking generally with the PK profile of adintrevimab, a previous Invivyd mAb with an estimated in vivo half-life of 139 days, as depicted in Figure 1 below. PK analysis of VYD2311 intravenous and subcutaneous cohorts at earlier timepoints, at either similar doses subcutaneously or higher doses intravenously, are similarly and encouragingly tracking close to the estimated curves for adintrevimab thus far.
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