Remove 2021 Remove Immune Response Remove Trials
article thumbnail

Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

article thumbnail

Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine

Drug Discovery Today

First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

The Pharma Data

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. “In Induction of innate immunity was investigated via specific cytokine markers.

article thumbnail

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

The Pharma Data

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. Beginning in February 2021, the study enrolled 722 volunteers, in the U.S. Issued: London UK.

article thumbnail

Moderna says its COVID-19 vaccine shows promise in elderly patients

The Pharma Data

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Moderna started a large-scale Phase 3 trial last month that will test the vaccine’s safety and effectiveness on 30,000 people with results expected in October.

Vaccine 90
article thumbnail

UK Pharma Company Scancell Selects COVID-19 Vaccine for Clinical Trials | 2020-12-21

The Pharma Data

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. Source link.

article thumbnail

Sanofi, GSK launch early trial for COVID-19 vaccine

The Pharma Data

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

Vaccine 52