XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Worldwide Clinical Trials

AUGUST 14, 2024

Molecular Biomarkers : Encompass various molecules, such as RNA and metabolites, to reflect the physiological state of the cells and their disease pathways. Protein-based Biomarkers : Include proteins found in blood, tissues, or other bodily fluids that can indicate disease presence or progression.

Genetics 195

Genetics Protein Gene Genotype 195

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry? What is a Receptor Occupancy Assay?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

Camargo

JULY 27, 2021

Research and development in the area is currently growing at a fast rate, and the National Institute of Health reports hundreds of clinical trials to test gene therapies for different genetic diseases, immune system disorders, oncology treatments, neurogenerative diseases, infectious diseases, and more.

Gene Therapy 238

Gene Therapy Gene Gene Editing Genetics 238

Pharmaceutical Technology

JULY 5, 2022

Researchers at the UNC School of Medicine have discovered that hepatitis A virus (HAV) replication needs particular interactions between the human protein ZCCHC14 and TENT4 poly(A) polymerases, a group of enzymes. In addition, the scientists later found that the HAV needs TENT4A/B for its replication.

Protein 130

Protein RNA Genome Genomics 130

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The therapeutic candidate consists of messenger RNA (mRNA) encoding for relaxin. It is developed based on messenger RNA expression and N2GL formulation platform. Buy the model here. The drug candidate is administered by intravenous route.

RNA 100

RNA Protein Antibody Vaccination 100

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

Protein 126

Protein Vaccine Vaccination Immune Response 126

pharmaphorum

JULY 20, 2022

Armed with a $100 million second-round financing, CAMP4 Therapeutics is preparing to start the first clinical trial of a drug targeting regulatory RNA (regRNA) molecules that can be used to fine-tune the expression of genes. ” The post CAMP4 raises $100m to take lead RNA drugs into clinic appeared first on. .

RNA 52

RNA Genetic Disease Drugs Protein 52

XTalks

DECEMBER 22, 2021

The RNA Revolution: From mRNA Vaccines to RNA Editing. The age of RNA is officially here, and it’s here to stay as more than a passing life science trend. RNA technology is not new nor has its potential been surprising. RNA in the Making. So why did this perceived RNA ‘revolution’ take so long?

Life Science 98

Life Science RNA Vaccination Vaccine 98

pharmaphorum

AUGUST 18, 2020

The trick is to look for proteins that are used across all coronavirus types and tend not to vary much from one virus species to another. If we can find any drugs that have gone into human beings if one of those has activity against COVID-19 proteins those would make it more rapidly through clinical trials.”.

Protein 121

Protein Pharma Companies RNA Drugs 121

Pharmaceutical Technology

NOVEMBER 22, 2022

Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. million in funding to support this work.

Manufacturing 130

Manufacturing Vaccine Vaccination RNA 130

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. and Leila Zegna, director of the Kabuki Syndrome Foundation.

Vaccine 98

Vaccine Vaccination Gene Therapy RNA 98

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

Delveinsight

SEPTEMBER 23, 2021

Boehringer stated that the Abexxa’s generation aims at cancer-specific proteins situated throughout the mobile versus proteins at the mobile membrane broadening the selection of possible cancer antigen objectives. 858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Jeffrey Stafford, Ph.D.,

RNA 61

RNA Gene Therapy Gene Protein 61

XTalks

JANUARY 3, 2024

In individuals affected by ATTR, which includes both hereditary and wild-type (non-hereditary) variants, the TTR protein forms fibrils that accumulate in various tissues. Safety and Efficacy of Wainua The FDA’s approval of Wainua is underpinned by compelling clinical data. This conjugation facilitates ASO delivery to hepatocytes.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

pharmaphorum

SEPTEMBER 17, 2020

An interim analysis of the BLAZE-1 clinical trial showed a reduced rate of hospitalisation in patients treated with Lilly’s LY-CoV555, an antibody that neutralises the SARS-CoV-2 coronavirus, in a phase 2 trial. However viral RNA sequencing revealed potential LY-CoV555-resistance variants in placebo and all treatment arms.

Antibody 129

Antibody RNA Trials Clinical Trials 129

The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. . CHENGDU, China , Feb. S-Trimer is intended to be adjuvanted.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

Pharmaceutical Technology

FEBRUARY 1, 2023

As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab. This is concerning as nirsevimab was very recently approved in only two regions.

Vaccine 162

Vaccine Vaccination Antibody Protein 162

XTalks

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). As of March 2024, the FDA has approved six small interfering RNA (siRNA) therapies.

Trials 52

Trials RNA Protein Gene Editing 52

The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

Protein 52

Protein Genome Genomics Research 52

pharmaphorum

JANUARY 10, 2023

The alliance has also yielded a computer vision system to improve the accuracy and speed of immune response evaluations, and a platform that has improved the success rate and throughput of DNA/RNA synthesis. The post BioNTech buys UK-based AI startup InstaDeep in £562m deal appeared first on.

Vaccination 116

Vaccination Vaccine Clinical Trials Clinical Trials 116

pharmaphorum

DECEMBER 13, 2021

Meanwhile, Sanofi also started a first clinical trial of an mRNA-based seasonal flu vaccine in June. The company expects to have two candidates in trials within 12 months and six within the next four years. Dormitzer comes from Pfizer, where he was chief scientific officer for RNA and viral vaccines for more than six years.

RNA 105

RNA Vaccine Vaccination Development 105

pharmaphorum

DECEMBER 1, 2020

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results. The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

Vaccine 88

Vaccine Vaccination RNA Clinical Trials 88

pharmaphorum

OCTOBER 31, 2022

The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

Genome 136

Genome Genomics Drugs RNA 136

pharmaphorum

NOVEMBER 10, 2021

Not so, says the NIH, which argues that three of its scientists – John Mascola, Barney Graham and Kizzmekia Corbett – should be named as co-inventors of the messenger RNA sequence coding for the SARS-CoV-2 spike protein that is the main component of Moderna’s mRNA-1273 shot. The patent has been filed but not yet awarded.

Vaccine 105

Vaccine Vaccination Scientist Protein 105

XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins.

Vaccine 98

Vaccine Vaccination FDA Approval Protein 98

XTalks

NOVEMBER 30, 2023

Its mechanism of action involves blocking the protein shell (capsid) of the HIV-1 virus, disrupting multiple crucial stages of the viral lifecycle. The FDA’s endorsement of Sunlenca is backed by compelling clinical evidence, demonstrating its efficacy as a viable treatment option. percent in the placebo group.

FDA Approval 111

FDA Approval Gene Therapy Gene Clinical Trials 111

XTalks

JUNE 18, 2024

.” — Aki Ko Additionally, Elixirgen Therapeutics has unveiled promising preclinical results for its Bobcat mRNA technology at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.

Protein 52

Protein RNA Genetics Gene Expression 52

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge.

Vaccine 77

Vaccine Vaccination RNA Clinical Trials 77

pharmaphorum

NOVEMBER 9, 2020

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier. Around 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.

Vaccine 98

Vaccine Vaccination Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 21, 2020

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code. As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

Vaccine 111

Vaccine Vaccination Doctor Doctors 111

pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19. The post Novavax provides 1.1

Vaccine 80

Vaccine Vaccination Manufacturing RNA 80

Delveinsight

JULY 29, 2021

Biogen and Ionis Pharmaceuticals have demonstrated that their experimental drug, BIIB080 (IONIS-MAPT), fulfilled the primary goal of safety and tolerability in the Phase Ib multiple ascending doses (MAD) clinical trials in mild Alzheimer’s disease patients. Details on the pipeline are still very thin.

Drugs 98

Drugs Protein Life Science Development 98

Delveinsight

JANUARY 7, 2021

The immunotherapy pipeline is led by an in-licensed EP4 antagonist that Ikena is testing combined with Keytruda in phase 1b/2 colorectal and non-small cell lung cancer clinical trials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinical trials. IND-enabling studies are underway.

RNA 52

RNA Clinical Trials Clinical Trials Bioavailability 52

Pharmaceutical Technology

FEBRUARY 1, 2023

However, subsequent RSV drugs, like Medimmune’s motavizumab, failed in clinical trials. A major breakthrough from the National Institutes of Health (NIH), in mapping the structure of the RSV protein significantly changed the landscape, allowing companies to leap into RSV drug research with better efficacy results.

Vaccine 162

Vaccine Vaccination Antibody Development 162