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.

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Gene Therapy Gene Gene Editing Genetics 238

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.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

pharmaphorum

SEPTEMBER 14, 2021

Repeat sequences aren’t involved in expressing proteins so have been generally under-studied by researchers, but there is increasing evidence that some human traits and diseases may be associated with mutations within them. Most drug discovery programmes target the roughly 2% of the human genome which encodes for protein.

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DNA Immune Response Genome Genomics 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 115

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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Vaccination Vaccine Gene Therapy RNA 98

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021.

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Vaccination Vaccine Immune Response Protein 52

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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Vaccination Vaccine Trials Protein 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

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 94

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. HER2 is a protein that plays an important role in cancer cell growth and is found on the surface of cancer cells in a very high quantity in about 10-20% of breast cancers. Rosenberg, M.D.

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Development DNA Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

Vaccination 52

Vaccination Vaccine Immune Response Protein 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. Neoantigen vaccines are designed to target certain proteins called neoantigens on tumor cells.

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Vaccination Vaccine Drugs Clinical Trials 98

The Pharma Data

JULY 6, 2021

Fitusiran is an investigational, subcutaneously administered small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors and has the potential to transform treatment as it would be the only prophylactic therapy with as few as six injections per year. ePoster Abstract # OC48.2

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Protein RNA Marketing Development 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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Vaccination Vaccine Manufacturing Clinical Development 52

Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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RNA Drugs Gene Silencing Vaccination 52

The Pharma Data

MAY 17, 2021

The investigational COVID-19 vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines, along with GSK’s established pandemic adjuvant technology. The interim results from the phase 2 trial on the vaccine, published today, on the contrary, showed a “ strong neutralizing antibody response” ?

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Immune Response Vaccination Vaccine Antibody 52

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 Vaccination Vaccine RNA 130

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.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Director of the FDA’s Center for Biologics Evaluation and Research.

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Vaccination Vaccine Production Manufacturing 52

Delveinsight

DECEMBER 13, 2020

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease.

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Genotype FDA Approval DNA Drugs 52

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.

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Vaccination Vaccine FDA Approval Protein 98

World of DTC Marketing

DECEMBER 29, 2020

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.

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Vaccination Vaccine Development Clinical Trials 307

Drug Discovery World

SEPTEMBER 6, 2022

And whilst clinical trials activity decreased by around 15% compared to 2020, last year still saw a number of regenerative medicines reach the bedside. According to the ASGCT, the gene therapy pipeline increased 16% from Q1 2021 with 3,579 gene, cell, and RNA therapies in development from preclinical through pre-registration stages.

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Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

FEBRUARY 6, 2023

Typically, the data obtained from such studies is large and high dimensional with thousands of molecules being measured for each individual sample requiring special statistical, data science, and bioinformatics skills to integrate the information and correlate it with the clinical outcome of interest.

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Big Data RNA Bioinformatics Vaccination 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

JANUARY 4, 2023

The researchers used high-dimensional immune profiling and single-cell RNA sequencing to study how the TIME is affected by a variety of immunotherapies. They identified specific immune checkpoint proteins, 41BB and LAG, that were highly expressed in exhausted T cells. . Details of the study .

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Immune Response Protein Antibody Research 52

Drug Discovery World

OCTOBER 6, 2022

In the cancer space alone over the last five years, clinical trials have increased 500% for new drugs and new drug combinations. New classes of therapies have added to this growth, including immune checkpoint inhibitors and genome targeted therapies. In pursuit of this, the number of new therapeutics in development has boomed.

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Medicine Clinical Trials Clinical Trials Genome 52

The Pharma Data

JUNE 25, 2021

The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).

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Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

OCTOBER 17, 2023

Today, spatial omics technologies enable imaging-based identification of cells in their native tissue context while simultaneously detecting hundreds of RNAs or tens of protein markers in the same cells. There is a lack of data and case studies beyond pilot projects related to patient recruitment and clinical trials.

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Gene Expression Drugs Protein Gene 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

The Pharma Data

DECEMBER 27, 2020

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related.

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Trials Antibody Gene Therapy Clinical Trials 52

Drug Discovery World

DECEMBER 15, 2022

Now, after nearly 35 years of research and more than a decade of preclinical progress, several different gene editing modalities are being tested in early phase clinical trials. Early phase clinical trials for gene editing therapies. DNA targeting specificity of RNA-guided Cas9 nucleases . References.

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Gene Editing Gene In-Vivo Genome 52

The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk.

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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. . INDICATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. The price of that prize is incalculable.

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Vaccination Vaccine Antibody Life Science 92