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

Pharmaceutical Technology

JUNE 8, 2023

The company’s samRNA vector is based on a synthetic RNA molecule derived from a wild-type Venezuelan Equine Encephalitis Virus (VEEV) replicon with the goal of extending the duration and magnitude of immunogen expression to drive potent and durable immune responses. GlobalData is the parent company of Clinical Trials Arena.

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Vaccination Vaccine Immune Response Allergies 130

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.

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Manufacturing Vaccine Vaccination RNA 130

Worldwide Clinical Trials

JUNE 15, 2022

The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials. But it’s important we strive to find ways to include diverse patients so trial data can be representative of the wider population.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

OCTOBER 25, 2020

German drugmaker CureVac said preclinical studies of its COVID-19 vaccine candidate, CVnCoV, showed the vaccination prompted a successful immune response. The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice.

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

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.

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Vaccine Vaccination Gene Therapy RNA 98

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. The start of dosing in the phase 1/1b trial of the drug has been delayed by the COVID-19 pandemic, but recruitment of the target 80 participants with advanced solid tumours is reported to be ongoing.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

XTalks

NOVEMBER 30, 2023

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

The Pharma Data

DECEMBER 14, 2020

Supported by promising phase 1 data, CureVac announced Monday that it has enrolled the first participant in the pivotal phase 2b/3 study of its messenger-RNA based coronavirus vaccine, CVnCoV. We are hopeful that this trial will continue to demonstrate the impact of mRNA technology,” said CureVac CEO Franz-Werner Haas. James Miessler.

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Vaccination Vaccine Trials Immune Response 52

Delveinsight

SEPTEMBER 23, 2021

858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Now, they are ready for their next venture, which is launching RNA biotech 858 Therapeutics with a USD 60 million Series A fundraising. have helped prepare more than 20 drug candidates for clinical trials. Jeffrey Stafford, Ph.D., Stafford and co.

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RNA Gene Therapy Gene Protein 61

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility.

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Vaccine Vaccination Clinical Trials Clinical Trials 116

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. TUESDAY, Dec. 8 in The Lancet. New data posted Tuesday on the U.S. © 2020 HealthDay.

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Vaccination Vaccine Trials Immune Response 52

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 Vaccination Vaccine 52

pharmaphorum

OCTOBER 6, 2020

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

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Vaccination Vaccine RNA Immune Response 59

pharmaphorum

OCTOBER 2, 2020

Genentech, which is already well established as a player in cancer immunotherapy with its PD-L1 class drug Tecentriq (atezolizumab) , will be responsible for development and marketing thereafter. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

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Vaccination Vaccine Immune Response Drugs 59

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 14, 2021

Rome Therapeutics – which officially launched last year – has made shining a light on the so-called ‘dark genome’ its mission, and has already discovered that repeats can play a critical role in human health, such as by switching on the innate immune response under stress.

DNA 52

DNA Immune Response Genome Genomics 52

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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Vaccination Vaccine Trials Immune Response 40

pharmaphorum

OCTOBER 12, 2022

The payload, Del Bourgo tell us, is the therapeutic DNA or RNA sequence that will cure or fix damaged cells. Similar to how we injected mRNA into people to trigger an immune response and train their immune system against COVID-19, genomic medicine repairs cellular or molecular mechanisms that are dysfunctional and cause disease.”.

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Genome Genomics Medicine Development 105

XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD. percent and severe RSV-associated LRTD by 94.1 percent compared to a placebo.

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Vaccination Vaccine FDA Approval Protein 98

pharmaphorum

SEPTEMBER 22, 2022

Le Vert says Osivax’s technology differs, however, as it attacks the virus’ T-cells, making the vaccine more effective in the long term, and that clinical trials have shown promise. The beauty of that T-cell response is that you can actually access the internal parts of the virus,” Le Vert states.

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Vaccination Vaccine Antibody Clinical Trials 97

The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

Vaccine 52

Vaccine Vaccination RNA Clinical Trials 52

STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines  can be greenlighted.

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Vaccine Vaccination Drugs Clinical Trials 98

The Pharma Data

DECEMBER 16, 2020

The Moderna vaccine is similar to Pfizer and BioNTech’s vaccine in the sense that they both use an approach utilizing messenger RNA (mRNA). Instead, it uses a genetic code, which tricks the body into developing an immune response to the virus.

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Vaccination Vaccine Immune Response FDA Approval 52

Roots Analysis

AUGUST 23, 2024

The idea behind mRNA vaccines is to use this natural process to incite an immune response: inject patients with a synthetic mRNA strand encoding a particular antigen – usually a protein, or part of a protein, recognized by the immune system – and their cells will produce the antigen in situ.

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Protein Vaccine Vaccination Immune Response 40

pharmaphorum

NOVEMBER 4, 2022

The influenza virus is subject to constant mutations to evade host immune response, and this causes the seasonal variation in circulating strains. The follow-up period for each participant will be a total of six months.

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Vaccine Vaccination Immune Response RNA 52

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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Vaccination Vaccine Protein Immune Response 52

The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S.

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Vaccine Vaccination Manufacturing Clinical Development 52

Roots Analysis

MAY 21, 2024

Several LNP-based therapies are currently being evaluated in the clinical trials; majority of these are conducted for treating breast cancer, ovarian cancer and lung cancer. In addition, these can be modified with ligands in order to improve the specificity and selectivity of the gene therapy and reduce off-target effects.

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Drug Delivery Drugs Gene Therapy Bioavailability 40

Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. In phase II clinical trial, led by Steven A. Rosenberg, M.D.

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Development DNA Clinical Trials Clinical Trials 52

VirTrial

OCTOBER 25, 2023

Members of the science and medicine team have additionally worked on hundreds of other vaccine trials involving hundreds of thousands more volunteers. Despite well-constructed and rigorous clinical trials looking at the vaccines, there were those that would not be immunized leading to further death and spread of the disease.

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Vaccination Vaccine Development Clinical Trials 52

Pharma Marketing Network

DECEMBER 21, 2020

those that modify the expression of an individual’s genes or repair abnormal genes) has entered clinical practice, including 11 RNA therapeutics, 2 in vivo gene therapies, and 2 gene-modified cell therapies. For example, “gene silencing” is a less-than-ideal description for the mechanism of RNA interference (RNAi) therapeutics.

Genetics 52

Genetics Medicine Gene Therapy Marketing 52

WCG Clinical

MAY 28, 2024

This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection. T cells and B cells also express specialized antigen receptors that impart specificity to the immune response, directing immune attack against foreign “non-self” targets while sparing “self” targets expressed by healthy tissue.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. 5) vaccine, each of which is based on BioNTech’s proprietary mRNA platform technology. .

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Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

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Vaccination Vaccine Production Manufacturing 52