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.

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Worldwide Clinical Trials

JUNE 15, 2022

Further, some patients are still hesitant to go into the clinic, and the prevalence of misinformation from the pandemic has led to greater concerns about therapies like gene therapies and the impact they fear it will have on their RNA/DNA. Working with a centralized IBC/IRB provider can speed up your process. .

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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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. of these are in the pre-clinical stage.

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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.,

RNA 61

RNA Gene Therapy Gene Protein 61

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

Drug Discovery World

FEBRUARY 13, 2023

SB: Transcriptomics is the study of genomic RNA transcripts in a biological system. RNA transcript expression levels can provide insight into underlying biology – eg. In terms of technical process, traditional RNA sequencing was a very laborious process that could take several weeks and was prone to errors. SB: Certainly.

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RNA Drugs Gene Expression Gene 52

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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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.

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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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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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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

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. InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

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Trials Gene Silencing RNA Gene Expression 59

Drug Discovery World

APRIL 16, 2023

The clinical benefit was observed regardless of the tumour mutational burden (TMB) status, according to results from the Phase IIb KEYNOTE-942 clinical trial presented at the AACR Annual Meeting 2023, held April 14-19.

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Vaccination Vaccine Immune Response Gene Expression 52

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

DECEMBER 8, 2020

. “In future analyses, with more data included as it becomes available, we will investigate differences in key subgroups such as older adults, various ethnicities, doses, timing of booster vaccines, and we will determine which immune responses equate to protection from infection or disease.” © 2020 HealthDay.

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VirTrial

OCTOBER 25, 2023

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. The studies reported the outcomes of thousands of volunteers who participated in the clinical trials which showed safety and efficacy of the vaccine.

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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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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

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

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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The Pharma Data

JANUARY 31, 2021

The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover’s COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

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Vaccination Vaccine Trials Protein 52

The Pharma Data

MAY 17, 2021

The interim results from the phase 2 trial on the vaccine, published today, on the contrary, showed a “ strong neutralizing antibody response” ? The companies also noted a high immune response after a single dose of the shot in patients with prior infection, indicating, they said, strong booster potential for the jab. “

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Immune Response Vaccination Vaccine Antibody 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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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. Employing the body’s own immune system against the tumour cells is a clever approach that proves to be highly successful in some cases, though research is continuously going on. . 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.

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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. Another potential clinical pathway is to use engineered exogenous circRNAs to produce therapeutic proteins within target cells.

RNA 52

RNA Drugs Gene Silencing Vaccination 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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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

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.

Protein 52

Protein RNA Marketing Development 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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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

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.

Gene Therapy 52

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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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

Delveinsight

DECEMBER 13, 2020

Even though clinical trial results were promising, adverse events and serious complications were observed. Hence, the persistence of cccDNA, the presence of integrated HBV DNA, and impaired innate and adaptive immune responses make it difficult to eliminate HBV from chronically infected patients.

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Genotype FDA Approval DNA Drugs 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. For more information, visit.

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