Invivyd | MedPath

Invivyd Challenges FDA with Citizen Petition to Prioritize Monoclonal Antibodies for COVID-19 Prevention

9 days ago

• Invivyd has submitted a Citizen Petition urging the FDA to reevaluate COVID-19 prevention strategies, emphasizing the need for monoclonal antibodies alongside vaccines in the endemic phase of the virus. • The company argues that current vaccine efficacy data is outdated, as it was collected when Americans were immunologically naïve and before immune-evasive Omicron variants emerged. • Invivyd recommends new clinical trials for COVID-19 vaccines that include seropositive patients, test against contemporary variants, and measure efficacy over at least six months.

Invivyd Initiates Measles Monoclonal Antibody Discovery Program to Address Critical Treatment Gap

10 days ago

• Invivyd has launched a discovery program for a measles monoclonal antibody (mAb) in response to direct requests from healthcare providers treating active measles cases and managing outbreaks. • Currently, no approved antiviral treatments exist for measles, with clinicians limited to high-dose Vitamin A or immune globulin, both having significant limitations for widespread clinical use. • With over 20 million unvaccinated Americans and declining vaccination rates threatening U.S. measles elimination status, the company aims to identify a preclinical candidate by 2025 that could serve both as treatment and post-exposure prophylaxis.

Invivyd Secures $30M Non-dilutive Loan Facility to Advance COVID-19 Antibody Pipeline

a month ago

• Invivyd has signed a $30 million term loan facility with Silicon Valley Bank, providing non-dilutive capital access contingent on meeting specific milestones and conditions. • The financing comes as Invivyd seeks FDA alignment on the regulatory pathway for VYD2311, a novel monoclonal antibody candidate for COVID-19 designed for intramuscular administration. • VYD2311 leverages the same antibody backbone as pemivibart (PEMGARDA), which recently received emergency use authorization for pre-exposure prophylaxis in immunocompromised patients.

FDA Denies Invivyd's EUA Expansion Request for COVID-19 Antibody Pemgarda

3 months ago

• The FDA has rejected Invivyd's application to expand Pemgarda's emergency use authorization for treating mild to moderate COVID-19 in immunocompromised patients without alternative treatment options. • Pemgarda maintains its current EUA status as the market's only pre-exposure prophylactic for COVID-19, following AstraZeneca's Evusheld withdrawal in 2023 due to variant resistance. • The decision triggered a significant market response, with Invivyd's stock value declining approximately 33%, dropping from $1.77 to $1.21 per share.

AMPLIFY Trial Shows Promise: Acalabrutinib Combinations Outperform Chemoimmunotherapy in CLL/SLL Treatment

3 months ago

• Phase III AMPLIFY trial demonstrates superior progression-free survival with acalabrutinib-venetoclax combinations compared to traditional chemoimmunotherapy in previously untreated CLL/SLL patients without del(17p) or TP53 mutation. • The triplet regimen of acalabrutinib-venetoclax-obinutuzumab showed the highest efficacy with 82% 3-year progression-free survival in unmutated IGHV patients, though it carried increased risk of COVID-19 complications. • Novel CD3 × CD20 bispecific antibody epcoritamab shows promising early results in heavily pretreated CLL/SLL patients, achieving 43-60% complete response rates with improved safety profile.

Five Novel 9-Month Oral Regimens Show Promise in Phase 3 Trial for Drug-Resistant TB

3 months ago

• Phase 3 endTB trial demonstrates that five all-oral 9-month regimens are as effective as standard 18-24 month treatment for rifampin-resistant tuberculosis, with four regimens proving noninferior. • New treatment combinations incorporating bedaquiline, clofazimine, levofloxacin, and pyrazinamide show favorable outcomes, though concerns about hepatotoxicity and peripheral neuropathy persist. • The successful trial highlights the importance of community-researcher trust, while emphasizing the need to address ongoing toxicity concerns in future treatment developments.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

Invivyd's VYD2311 Shows Promise as COVID-19 Protection Alternative in Phase 1/2 Trial

4 months ago

• Invivyd's VYD2311 demonstrates positive safety and pharmacokinetic profiles in an ongoing Phase 1/2 clinical trial, with complete enrollment and dosing. • In vitro data indicates VYD2311 has a 17-fold greater neutralization potency against tested SARS-CoV-2 variants compared to pemivibart. • VYD2311 could offer stronger protection against symptomatic COVID-19 with less frequent dosing and improved tolerability compared to current vaccines. • The monoclonal antibody shows potential as both a convenient frontline protection and a potent, long-acting treatment option for COVID-19.

Monoclonal Antibody Shows Promise Against Dominant COVID-19 Variant

4 months ago

Inviyd's monoclonal antibody, pemivibart (Pemgarda), has demonstrated neutralizing activity against over 75% of currently circulating US COVID-19 variants and all prior tested variants, showcasing its potential in combating the virus's evolution.

Invivyd's Pemgarda Shows Continued Neutralizing Activity Against SARS-CoV-2 Variant XEC

4 months ago

• Invivyd's PEMGARDA (pemivibart) demonstrates consistent neutralizing activity against the dominant SARS-CoV-2 variant XEC in new in vitro data. • XEC and KP.3.1.1, both susceptible to PEMGARDA, constitute the majority (69%) of circulating SARS-CoV-2 variants in the U.S., according to CDC estimates. • Pemivibart has shown antiviral activity against 39 distinct SARS-CoV-2 variants over three years, with minimal change in neutralizing activity. • Data has been submitted to the FDA, and an update to the PEMGARDA Fact Sheet for Healthcare Providers is expected soon.

Invivyd's Pemivibart Shows Long-Term COVID-19 Protection in CANOPY Trial

6 months ago

• Invivyd's CANOPY phase 3 trial data demonstrates pemivibart's efficacy as pre-exposure prophylaxis (PrEP) for COVID-19, including protection against recent JN.1 sublineages. • Pemivibart (Pemgarda) received EUA from the FDA for PrEP of COVID-19 in immunocompromised patients, supported by immunobridging data from the CANOPY trial. • Long-term follow-up data from CANOPY showed continued protection against KP.3 and KP.3.1.1 variants, even after cessation of drug, with low residual titers. • Invivyd scientists developed a novel methodology using a multi-antibody panel to predict neutralization behavior against emerging viral variants, enhancing confidence in antibody activity assessments.

Invivyd's Pemivibart Shows 76% Protection Rate Against COVID-19 in Phase 3 Trial

7 months ago

• Invivyd's Pemivibart demonstrated a 64% relative risk reduction in COVID-19 infection compared to placebo during months 7-12 of the CANOPY Phase 3 trial. • The trial showed an overall 12-month protection rate of 76% following two doses of Pemivibart, indicating sustained efficacy without continued dosing. • Pemivibart's safety profile remained consistent over the 12-month study, with no new safety signals or trends observed. • Invivyd reported $9.3 million in Pemgarda net product revenue for Q3, but withdrew its previous FY24 revenue guidance due to FDA concerns about reduced activity.

Invivyd's Pemgarda Shows 76% Risk Reduction in Symptomatic COVID-19 Over 12 Months

7 months ago

• Invivyd's Pemgarda demonstrated a 76% relative risk reduction in symptomatic COVID-19 over 12 months in the CANOPY Phase 3 trial. • During the off-drug follow-up (months 7-12), Pemgarda reduced the risk of symptomatic COVID-19 by 64% compared to placebo, despite declining drug concentrations. • The study included both immunocompromised and immunocompetent adults, highlighting the need for effective preventive measures across diverse populations. • No new treatment-emergent adverse events were reported, reinforcing Pemgarda's consistent safety profile throughout the 12-month monitoring period.

Invivyd's Pemivibart Shows Promising Clinical Efficacy in COVID-19 Prevention

7 months ago

• Invivyd's pemivibart, an investigational mAb, is being evaluated in the Phase 3 CANOPY trial for COVID-19 prevention in immunocompromised individuals and those at risk of exposure. • The CANOPY study assesses pemivibart's efficacy in preventing symptomatic COVID-19, with additional objectives including safety, tolerability, pharmacokinetics, and prevention of RT-PCR-confirmed cases. • Exploratory efficacy endpoints in the CANOPY trial include RT-PCR-confirmed symptomatic COVID-19, with detailed symptom duration and severity data collected post-infection. • Baseline demographics from the CANOPY trial indicate a diverse study population, including participants with various risk factors for severe COVID-19 and varying levels of prior vaccination.

FDA Updates Pemgarda EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility Data

8 months ago

• The FDA updated the PEMGARDA™ EUA Fact Sheet to reflect accurate in vitro neutralization activity against dominant circulating variants KP.3.1.1 and LB.1. • The updated Fact Sheet removes a contested statement regarding potentially reduced susceptibility of KP.3.1.1 to pemivibart, based on data from LabCorp's Monogram Biosciences lab. • Invivyd continues active variant monitoring and asserts that PEMGARDA is likely to retain adequate neutralization activity against currently circulating SARS-CoV-2 variants in the U.S. • Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart for assessing neutralization potency and variant susceptibility.

Pemivibart Guidelines Updated for COVID-19 Preexposure Prophylaxis in Immunocompromised Patients

8 months ago

• The FDA authorized pemivibart for preexposure prophylaxis of COVID-19 in moderately to severely immunocompromised individuals aged 12 years and older. • IDSA updated its COVID-19 treatment guidelines, suggesting clinicians use pemivibart prophylactically when circulating variants are susceptible. • Pemivibart's efficacy is inferred via immunobridging, comparing it to adintrevimab, which showed reduced symptomatic COVID-19 risk in trials. • Emerging data suggest potential reduced susceptibility of pemivibart to newer variants, necessitating ongoing monitoring and research efforts.

Invivyd Initiates Phase 1 Trial of VYD2311, a Novel Monoclonal Antibody for COVID-19

9 months ago

• Invivyd has dosed the first participants in a Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody (mAb) candidate for COVID-19. • The Phase 1 trial is a randomized, blinded, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311 in healthy volunteers. • VYD2311 was engineered from adintrevimab and aims to provide enhanced protection against current and future SARS-CoV-2 variants, especially for immunocompromised individuals. • Preliminary data from the Phase 1 trial are expected in the fourth quarter of 2024, with additional clinical readouts anticipated throughout 2025.

Adimab Announces 2023 Clinical Pipeline Update with 12 New Partner Programs

a year ago

Adimab, LLC, a leader in antibody discovery and engineering, reported that 12 new partner programs entered clinical development in 2023, increasing the total number of Adimab partner programs in clinical development to 74. The company highlighted the success of its platform, including the approval of two products and the filing of a Biologics License Application (BLA) in 2023, with three programs currently in pivotal trials.